Example 001 101 Merged

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:53:11 G
CTRI Number CTRI/2011/08/001935 [Registered on: 02/08/2011] - Trial Registered Prospectively

Last Modified On 15/04/2019
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study A Placebo- and Active-Controlled Study of Preladenant in Early Parkinsons Disease (P
Scientific Title of A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Rang
Study Efficacy and Safety Study of Preladenant in Subjects With Early Parkinsons Disease (
Protocol No. P05664)
Secondary IDs if Any Secondary ID

NCT01155479
P05664 28 Jul 11 Amend 4
Details of Principal
Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address
Phone
Fax
Email
Details Contact
Person (Scientific Name Dr Monisha Sharm
Query)
Designation Medical Director
Affiliation MSD Pharmaceutic
Address 6th Floor, Vatika To
HARYANA 122002
Gurgaon
HARYANA
122002
India
Phone 91-124-4647300
Fax 911244375561
Email monisha_sharma@
Details Contact
Person (Public Query) Name DrMonisha Sharma
Designation Director Clinical Re
HARYANA 122002
Gurgaon
HARYANA
122002
India
Phone 91-124-4647300
Fax 911244375561
Source of Monetary or
Material Support > Merck Sharp and Dohme One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08
Primary Sponsor
Name Merck Sharp and D
Address One Merck Drive P
USA
Type of Sponsor Pharmaceutical ind
Details of Secondary Name

Sponsor Fulford India Limited
Countries of List of Countries

Recruitment Argentina
Bulgaria
Canada
Chile
Colombia
Czech Republic
Finland
France
Germany
Hungary
India
Israel
Italy
Mexico
Peru
Poland
Russian Federation
Spain
Sweden
Turkey
United Kingdom
United States of America
Sites of Study Name of Principal Name of Site

Investigator
Dr Madhuri Behari AIIMS
Dr Chandrashekhar Brain and Mind

Meshram
Dr Mohit Bhatt Kokilaben Dhirubhai

Ambani Hospital
Dr Vijayan Krishnan Kovai Medical Center

and Hospital Limited
Dr Rangashetty M S Ramaiah Medical

Srinivasa College and Hospitals
Dr Shankara Nellikunja Mallikatta Neu
Dr Puneet Agarwal Max Super Speciality

Hospital
Dr Uday Muthane Parkinson’s & Ageing

Research Foundation,
Dr Asha Kishore Sree Chitra Tirunal

Institute for Medical
Sciences & Technology
Dr Suresh Kumar Vijaya Health Centre
Details of Ethics Name of Committee Approval Status

Committee
Brain & Mind Institute Approved
EC- Vijaya Health Approved
Centre
Institutional Ethics Submittted/Under
Committee (IEC) - Review
SCTIMST
KMCH Ethics Submittted/Under

Committee Review
Kokilaben Dhirubhai Approved
Ambani
M.S. Ramaiah Medical Approved
College and Teaching
Hospital
Mallikatta NeuroCentre Approved
Max Superspeciality Approved
Hospital
PArkinsons& Ageing Approved
Research Foundation
Regulatory Clearance Status

Status from DCGI Approved/Obtained
Health Condition / Health Type

Problems Studied Patients
Patients
Intervention / Type
Comparator Agent Intervention
Comparator Agent
Comparator Agent
Inclusion Criteria
Age From 30.00 Year(s)
Age To 85.00 Year(s)
Gender Both
Details • Each subjec
than 5 years based
Disease Society Br
criteria for this prot
bradykinesia and a
Each subject who i
PDF of Trial
CTRI Website URL - http://ctri.nic.in
must have been on a stable regimen of treatment for at least

the 5 weeks immediately before Screening. (Note: Subjects who are
not taking any medications for PD are permitted to enroll in this
trial.) • Each subject must have a UPDRS Part 3 score of
³10. • Each subject’s Hoehn and Yahr Stage must be £3. 
• Each subject must be willing and able to provide written informed
consent for the trial. • Each subject must be ³30 to £85 years
of age. A subject may be of either gender and any
race/ethnicity. • Each subject must have results of Screening
clinical laboratory tests (hematology, blood chemistries, and 
urinalysis) drawn within 5 weeks prior to Randomization, clinically
acceptable to the investigator, and not within the parameters
specified for exclusion (below). • All subjects that are sexually
active or plan to be sexually active agree to use a highly effective
method of birth control while the subject is in the study and for 2
weeks after the last dose of study drug. A male subject must
also not donate sperm during the trial and within 2 weeks after the
last dose of study drug. Exclusion Criteria: • A
subject must not have a form of drug-induced or atypical
parkinsonism, cognitive impairment (ie, Montreal Cognitive
Assessment [MoCA] score <22), bipolar disorder, schizophrenia, or
other psychotic disorder. • A subject must not have a
history of any of the following: - repeated strokes with stepwise
progression of Parkinsonian features - repeated head
injury - definitive encephalitis - oculogyric crises -
neuroleptic treatment at onset of symptoms - more than one
first degree relative affected - sustained remission - strictly
unilateral features after 3 years - supranuclear gaze palsy 
- cerebellar signs - early severe autonomic involvement -
severe symptomatic autonomic involvement unrelated to
medications - early severe dementia with disturbances of
memory, language, and praxis - Babinski sign with clear,
clinically significant pyramidal tract involvement - presence of
cerebral tumor or communicating hydrocephalus on neuroimaging
(by history) - negative response to large doses of L-dopa (if
malabsorption excluded) - MPTP
(1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) or known neurotoxin
exposure - hallucinations unrelated to medications - stroke
within 6 months of Screening or persistent neurological deficit that
may interfere with study assessments - surgery for
PD • A subject must not have been treated with L-dopa or
dopamine agonists for other than diagnostic purposes. If a
subject has received L-dopa or dopamine agonists for diagnostic
purposes, he/she must not have received the L-dopa or
dopamine agonist within 30 days before Randomization. • A
subject must not have an untreated major depressive disorder
meeting Diagnostic and Statistical Manual of Mental Disorders
IV Text Revision criteria or Beck Depression Inventory II] {BDI
II} score ?19. A subject who is successfully treated [Beck
Depression Inventory, Version II {BDI-II} score <19] with stable
doses of allowed antidepressant medications for at least the 5 weeks
immediately before Screening is eligible to enroll in the
trial. • A subject must not be at imminent risk of self-harm or
harm to others, in the investigator’s opinion based on clinical
interview and responses provided on the Columbia - Suicide Severity
Rating Scale (C-SSRS). Subjects must be excluded if they
report suicidal ideation of Type 4 or 5 in the past 2 months or
suicidal behavior in the past 6 months as measured by the
C-SSRS at Screening or Baseline. • Blood Pressure: A subject
must not have a systolic blood pressure (BP) ³150 mm Hg OR
diastolic BP ³95 mm Hg at Screening and at a BP recheck prior
page 5 / 8
to Randomization.
must not have had
or procedure
but not limited to, m
[a subject must not
unstable angi
heart failure staged
IV. • Liv
aminotransferase (
x the upper limit of
 • Liver
serologically confir
infection [Hepatitis
cytomegalovirus {C
alcohol-induced he
subject must not ha
or recurrent malign
treated basal cell o
cancer, or in s
prostate-specific an
Concomitant Medic
treatment listed in t
continue to receive
trial, unless e
trial. • A
consumption of mo
wine or the equival
controlled diabetes
renal function
investigator. •
unstable medical c
cardiac disease, sy
alcohol/drug depen
participated in any
not have allergy/se
excipients. • A
considering breast-
pregnant or intendi
have any clinically
condition being<br/
would interfere with
in the trial. • A
drugs within 90 day
must not have bee
days, inclusive, of s
current trial. •
member of the pers
directly involved wi
Exclusion Criteria
Details - Must not have a f
cognitive impairme
score less than 22)
disorder, schizophr
exposure to a know
consistent with the
- Must not have ha
- Must not have a h
progression of Park
PDF of Trial
months of Screening; poorly controlled diabetes; abnormal renal

function; or a severe or ongoing unstable medical condition.
- Must not have an untreated major depressive disorder meeting

Diagnostic and Statistical Manual of Mental Disorders IV Text
Revision criteria. (A subject who is successfully treated [Beck
Depression Inventory, Version II {BDI?II} score 19] with stable doses
of allowed antidepressant medications for at least the 4 weeks
immediately before Screening is eligible to enroll in the trial.).
- Must not have failed to show a therapeutic response if a diagnostic

levodopa (L dopa) challenge had been done with a large test dose
(500 mg) of L dopa (if malabsorption excluded).
- Must not have been treated with L dopa or dopamine agonists for
other than diagnostic purposes (within 30 days before Screening).
- Must not be at imminent risk of self-harm or harm to others.
- Must not have elevated blood pressure (BP) (systolic BP greater

than or equal to 150 mm Hg or diastolic BP greater than or equal to
95 mm Hg) that cannot be adequately controlled with
antihypertensive medication, as demonstrated by 2 BP
measurements meeting acceptable BP criterion at consecutive
scheduled or unscheduled visits within 5 weeks prior to
Randomization.
- Must not have had any clinically significant cardiovascular event or

procedure for 6 months prior to Randomization, including, but not
limited to, myocardial infarction, prolonged QTc interval, angioplasty,
unstable angina, or heart failure; and a subject must not have heart
failure staged New York Heart Association Class III or IV.
- Must not have an alanine aminotransferase (ALT) or aspartate

amino transferase (AST) 3 x the upper limit of normal (ULN) or total
bilirubin (T BIL) 1.5 x ULN.
- Must not have active serologically-confirmed hepatic dysfunction

(defined as viral infection [Hepatitis B, C, or E; Epstein-Barr virus
(EBV)]; cytomegalovirus [CMV] or a history of diagnosis of drug- or
alcohol-induced hepatic toxicity or frank hepatitis, or a history of
diagnosis of drug- or alcohol-induced hepatic toxicity or frank
hepatitis.
- Must not have a history within the past 5 years of a primary or

recurrent malignant disease with the exception of adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, or in
situ prostate cancer with a normal prostate-specific antigen (PSA)
post resection.
- Must not have received certain prespecified medications or

ingested high tyramine-containing aged cheeses (eg, Stilton) for a
prespecified time window before the trial, during the trial, and for 2
weeks after the trial.
- Must not have an average daily consumption of more than three 4

ounce glasses (118 mL) of wine or the equivalent.
- Must not have a severe or ongoing unstable medical condition (eg,

any form of clinically significant cardiac disease, symptomatic
orthostatic hypotension, seizures, or alcohol/drug dependence).
page 7 / 8
- Must not have alle

its/their excipients.
- Must not be breas
intending to becom
- Must not have us
within 90 days imm
Method of Generating Computer generated randomization

Random Sequence
Method of Centralized
Concealment
Blinding/Masking Participant, Investigator and Outcome Assessor Blinded
Primary Outcome Outcome
Change from Baseline in the Sum of Unified
Parkinsons Disease Rating Scale Parts 2 and 3
scores (UPDRS2 plus 3)
Secondary Outcome Outcome

Proportion of Responders (Proportion of
participants with a greater than or equal to 20
percent improvement in UPDRS2 plus 3)
Change from Baseline in the UPDRS Part 2
score (Activities of Daily Living [ADL])
Target Sample Size Total Sample Size=1000

Sample Size from India=100
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termina
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termina
Phase of Trial Phase 3

Date of First 02/08/2011
Enrollment (India)
Enrollment (Global)
Estimated Duration of Years=3
Trial Months=4
Days=0
Recruitment Status of Other (Terminated)

Trial (Global)
Trial (India)
Publication Details
Brief Summary Protocol P05664 is a 2-part, 52-week trial; each part will be 26 weeks in duration. The
Part 1 is to demonstrate efficacy and safety of preladenant for the treatment of early P
Disease; Part 2 will assess the long term safety of preladenant.
In Part 1, subjects will be randomly assigned to 1 of 5 treatment groups: preladenant 2
twice-daily (bid), preladenant 5 mg bid, preladenant 10 mg bid, rasagaline 1 mg once-
placebo bid. Subjects who complete Part 1 will move directly into Part 2 and will rema
treatment group they were randomly assigned to in Part 1 with the exception of subjec
assigned to the placebo group. Subjects who received placebo in Part 1 will be admin
of preladenant bid in Part 2. Thus, Part 2 will have 4 treatment groups: Preladenant 2,
bid and rasagaline 10 mg qd.
Type of Study Drug
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study An Active-Controlled Extension Study to P04938 and P07037 (Study P06153 AM3)
Scientific Title of A Phase 3, 40?Week, Active?Controlled, Double?Blind, Double?Dummy Extension St
Study Preladenant in Subjects With Moderate to Severe Parkinsons Disease
NCT01215227
P06153, Version 1; dated 5 Nov 2010
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact
Person (Scientific Name Dr Monisha Sharm
Query)
Designation Director- Clinical R
HARYANA 122002
Gurgaon
HARYANA
122002
India
Phone 91-124-4647300
Fax 91-124-4375561
Details Contact
Person (Public Query) Name Dr Monisha Sharm
Designation Director- Clinical R
HARYANA 122002
Gurgaon
HARYANA
122002
India
Phone 91-124-4647300
Fax 91-124-4375561
Material Support > Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred
SPONSOR or Merck) One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0
Primary Sponsor
Name Merck Sharp Dohm
Address One Merck Drive P
USA

Sponsor Fulford India Limited

Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Finland
France
Germany
India
Ireland
Israel
Italy
Latvia
Lithuania
Mexico
Netherlands
New Zealand
Peru
Poland
Portugal
Russian Federation
Serbia
South Africa
Spain
Sweden
Turkey
Ukraine
United Kingdom

Investigator
Dr Mohit Bhatt Kokilaben Dhirubhai
Ambani Hosp.& Med.
Research Institute
Dr Angamuthu Meena Nizam Institute of

Medical Sciences
Dr Charulata Sankhla P.D.Hinduja National
Hospital & Medical
Research Centre
Dr Uday Muthane Parkinson’s & Ageing

Research Foundation
Dr Asha Kishore Sree Chitra Tirunal

Institute for Medical
Sciences & Technology
Dr Sarma St. Johns Medical

College Hospital
Dr Suresh Kumar Vijaya Health Centre

Committee
Institutional Ethical Approved
Review Board, St.
Johns Medical College
Site 1: IEC - Kokilaben Approved
Dhirubhai Ambani
Hospital
Site 2: IEC - Sree Not Applicable
Chitra Tirunal Institute
for Medical Sciences &
Technology
Site 3: Institutional Approved

Ethics Committee,
NIMS
Site 4: Institutional Approved
Ethics Committee
Site 5: National Health Approved
& Education Society
The Ethics Approved
Committee,175 NSK
Salai, Chennai, Tamil
Nadu

Patients
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details - Participants who
the parent trial, P04
willing and able to
 - Participants
schedules. -
 - Participants
(e.g., dopamine ag
have results of clin
chemistries, and ur
acceptable to the in
results from the pa
within the paramete
criterion for liver-re
in, or there has bee
(for cytomegaloviru
B, C, and E). 
examination within
normal limits or clin
within the paramete
criterion for blood p
active or plan to be
method of birth con
weeks after the las
donate sperm withi
Exclusion Criteria
Details Exclusion Criteria:
- Any participant w
reason.
- Any participant w
(e.g. any form of cl
orthostatic hypoten
- Any participant w
HbA1c greater than
creatinine greater t
- As a continuation
parent studies (P04
values for alanine a
aminotransferase (
most recent chemis
one of the following
- ALT or AST great
- ALT or AST great
- ALT or AST great
or international nor
to anti-coagulation)
- ALT or AST great
worsening fatigue n
tenderness fever ra
- As a continuation
from the parent stu
the following criteri
separated by 7 day
once already 7 day
- Systolic BP great
greater than or equ
- An elevation from
P07037) of systolic
diastolic BP greate
- A participant mus
primary or recurren
adequately treated
cervical cancer or i
prostate-specific an
- Any participant w
three 4-ounce glas
- A participant mus
medications or inge
Stilton) for a prespe
and for 2 weeks aft
- Any participant w
products or their ex
- Any female partic
- Any female partic
- Any participant w
other than the cond
investigator would
participation in the
- Any participant w
of the investigation

Random Sequence
Concealment
Blinding/Masking Double Blind Double Dummy
1. Incidence of systolic blood pressure (SBP) ?
180 mm Hg
2. Incidence of diastolic blood pressure (DBP) ?
105 mm Hg
3. Incidence of alanine aminotransferase (ALT) ?
3 x upper limit of normal and with a ?10%
increase from baseline
4. Incidence of aspartate aminotransferase
(AST) ? 3 x upper limit of normal and with a
?10% increase from baseline
5. Columbia Suicide Severity Rating Scale
(CSSRS): Suicidality, Suicidal Behavior, Suicidal
Ideation
6. Epworth Sleepiness Scale Score

To characterize the long-term efficacy of
preladenant in subjects with
moderate to severe PD.


Enrollment (India)
Enrollment (Global)
Trial Months=2
Days=10

Trial (Global)
Trial (India)
Publication Details NA
Brief Summary The purpose of this trial is to assess safety data collected for up to 52 weeks (from the
P04938 or P07037 to the end of P06153) and to characterize the efficacy of preladena
same time period in participants with moderate to severe Parkinson’s disease (PD).
A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double Dummy Extension Stud
The purpose of this trial is to assess safety data collected for up to 52 weeks (from the
P04938 or P07037 to the end of P06153) and to characterize the efficacy of preladena
same time period in participants with moderate to severe Parkinson’s disease (PD).
A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double Dummy Extension Stud
Preladenant in Subjects With Moderate to Severe Parkinson’s Disease
Number of Trial Centers: Approximately 163 sites.
Duration of Participation: Each subject will participate for approximately 42 weeks
weeks of active treatment followed by a 2-week Safety Follow-Up Visit).
Duration of Trial: The trial will require approximately 3 years from the beginning to th
overall trial (first subject signing informed consent to last contact with last subject).
Preladenant is a tablet. Rasagiline will be supplied as a capsule. A placebo tablet matc

preladen
will be available; and a placebo capsule matching rasagiline also will be available.
During the 40-week Treatment Period, subjects will receive one tablet and one cap
morning and one tablet orally each evening in a double-blind, double-dummy design
AUSTRIA
BRAZIL
BULGARIA
CANADA
CZECH REPUBLIC
FINLAND
FRANCE
GERMANY
INDIA
ISRAEL
ITALY
NETHERLANDS
PERU
POLAND
RUSSIA
SPAIN
TURKEY
UNITED KINGDOM
USA
Type of Study Biological
Study Design Single Arm Study
Public Title of Study Induction therapy with Thymoglobuline in live donor renal transplant
Scientific Title of An Observation study of Thymoglobuline as Induction therapy in a steriod free mainte
Study immuno-supressive protocol for INDIAN patients undergoing live donor renal transplan
NIL
Investigator or overall Name Dr Vijay Kher
Trial Coordinator
Designation Chairman
Affiliation Medanta - The Med
Address Division of Nephrol
Kidney & Urology I
Gurgaon
HARYANA
122001
India
Phone 9811054118
Fax
Email vijay.kher@medan
Details Contact
Person (Scientific Name Dr Vijay Kher
Query)
Kidney & Urology I
Gurgaon
HARYANA
122001
India
Phone 9811054118
Fax
Details Contact
Person (Public Query) Name Dr Vijay Kher
Kidney & Urology I
Gurgaon
HARYANA
122001
India
Phone 9811054118
Fax
Material Support > Genzyme Corporation 55 Cambridge Parkway Cambridge, MA 02142 USA
Primary Sponsor
Name Dr Vijay Kher
Address Chairman - Division
Medanta Kidney &
Sector-38 Gurgaon
Type of Sponsor Private hospital/clin

Sponsor NIL
Recruitment India

Investigator
Dr Vijay Kher Medanta - The Medicity

Committee
Medanta Independent Approved
Ethics Committee

Status from DCGI Notified
Notified
Intervention / Type
Inclusion Criteria
Gender Both
Details Recipients of first li
more or equal to 18
child bearing poten
negative serum B-H
to practice an acce
the study Sign
Exclusion Criteria
Details 1. Recipients taking
2. Recipients requi
3. Recipients who a
4. Recipients with H
5. CMV sero-negat
sero-positive donor
6. Pregnancy
7. Patients with Kn
antithymocyte glob
8. Patients with kno
9. Participation in a
pharmaceutical
10. Inability or miss
11. Any other signi
opinion of the Inves
Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Not Applicable
Concealment
Blinding/Masking Open Label
To observe at 6 months the efficacy of two
infusions of Thymoglobuline induction (3mg/kg
over at least 6 hours on Day 0 and 3mg/kg over
at least 6 hours on Day 1) to prevent acute
rejections in a steroid free maintenance protocol
in patients undergoing living donor first renal
transplantation

To observe at 6 months from the date of
transplant, the incidence of asymptomatic CMV
infections, symptomatic CMV infection/disease
and treated CMV episodes in patients with
steroid free immunosuppression undergoing
living donor first renal transplantation with
induction of Thymoglobuline

Phase of Trial N/A

Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Trial Months=0
Days=0
Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary This is a prospective, ope

Medicity, Sector 38, Gu
transplantation in our livin
sign an ethics committee ap
All patients will be monitored
week in the second month
post-transplant, and then once a m
study visits, complete blo
at every study visit.
In addition, at baseline a
urine protein creatinine r
post transplant, HbA1C and
DEXA scan will also be done.
All recipients will be scree

of CMV test will at baseline
months and thereafter once monthly fo
Patient with delayed graft dysfunc

standard practice in the institution.
CTRI Number CTRI/2011/06/001790 [Registered on: 08/06/2011] - Trial Registered Retrospective

Post Graduate Thesis Yes
Type of Study Diagnostic
Public Title of Study Role of Videoelectroencephalography and brain scan in severe epilepsy
Scientific Title of clinical correlation of videoelectroencephalography and Advanced neuroimaging inn re
Study epilepsy
NIL
Investigator or overall Name Dr Prakash Kori
Trial Coordinator
Designation Senior Resident
Affiliation chatrapati shahuji m
Address Dr prakash kori sen
shahuji maharaj me
Lucknow
UTTAR PRADESH
226012
India
Phone 07398842297
Fax -
Email drprakashkori@gm
Details Contact
Person (Scientific Name Dr RKGarg
Query)
Designation Prof and HOD dep
Affiliation Professor and head
university lucknow
Address Dr R.K.Garg DM P
maharaj medical un
Lucknow
UTTAR PRADESH
226012
India
Phone 9335901790
Fax -
Email garg50@yahoo.com
Details Contact
Person (Public Query) Name Dr Prakash Kori
Designation Senior Resident
Affiliation seniro resident cha
Address Dr prakash kori sen
maharaj medical un
Lucknow
UTTAR PRADESH
226012
India
Phone 07398842297
Fax -
Material Support > chatrapathi shahuji maharaj medical college university lucknow
Primary Sponsor
Name nil
Address not applicable
Type of Sponsor Other [not applicab

Sponsor NIL

Recruitment India
India
Investigator
R K Garg ,chatrapathi shahuji
maharaj medical
college university
lucknow

Committee
institutional ethics Approved
committee

Status from DCGI Not Applicable
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details All Patients with ep
our study proposed
antiepileptic drugs
month over 18 mon
will be included in o
Exclusion Criteria
Details Those patients with
antiepileptic medic
antiepileptic or dos
Method of Generating
Random Sequence
Method of
Concealment
Blinding/Masking
control of seizures

nil

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details not yet
Brief Summary The patients having uncontrolled epilepsy that is uncontrolled on two or more antiepile
and having atleast one or more than one seizure episode per month in last 18 months
in our study. These patients will be evaluated in detail clinical features and syndromic
possible will be made.They further undergo Video EEG and epileptiform discharges ar
localised to particular part of brain. The patients will also undergo advanced Neuroima
and results are analysed in terms of etilogy and site of localisation in the brain. The re
analysed in terms of common etiology of refractory epilepsy and is there any significan
The patients having uncontrolled epilepsy that is uncontrolled on two or more antiepile
and having atleast one or more than one seizure episode per month in last 18 months
in our study. These patients will be evaluated in detail clinical features and syndromic
possible will be made.They further undergo Video EEG and epileptiform discharges ar
localised to particular part of brain. The patients will also undergo advanced Neuroima
and results are analysed in terms of etilogy and site of localisation in the brain. The re
analysed in terms of common etiology of refractory epilepsy and is there any significan
between localisation by Neuroimaging and VideoEEG. The patients are

months and response antiepileptic are noted.

Type of Study Drug
Public Title of Study A clinical trial to assess the efficacy and safety of mycophenolate modified release tab
prophylaxis of acute rejection of renal transplantation
Scientific Title of AN OPEN LABEL, RANDOMIZED, CONTROLLED MULTICENTRE STUDY TO ASSE
Study EFFICACY AND SAFETY OF MYCOPHENOLATE MR TABLETS* (PANACEA BIOTE
COMPARISON WITH MYFORTIC (NOVARTIS PHARMACEUTICALS CORPORATIO
PROPHYLAXIS OF ACUTE REJECTION OF RENAL TRANSPLANTATION

PBL/CR/2010/05/CT; Version: 3.0 of 20-01-12
Investigator or overall Name Dr Arani Chatterjee
Trial Coordinator
Designation Senior Vice Presid
Affiliation
Address Panacea Biotec Ltd
Estate, Mathura Ro
New Delhi
DELHI
110044
India
Phone 011-41679000
Fax 011-41578085
Email aranichatterjee@pa
Details Contact
Person (Scientific Name Dr Arani Chatterjee
Query)
Affiliation
Estate, Mathura Ro
New Delhi
DELHI
110044
India
Phone 011-41679000
Fax 011-41578085
Details Contact
Person (Public Query) Name Dr Arani Chatterjee
Affiliation
Estate, Mathura Ro
New Delhi
DELHI
110044
India
Phone 011-41679000
Fax 011-41578085
Material Support > Panacea Biotec Ltd, New Delhi
Primary Sponsor
Name Panacea Biotec Ltd
Address B-1 Extn/G-3, Moh
Delhi-110044

Sponsor NA
Recruitment India

Investigator
Dr N K Mohanty Apollo Hospital
Dr Vijay Kher Medanta- The Medicity
Dr D K Pahari Medica Superspeciality

Hospital
Dr D S Ray RTIICS Hospital
Dr A D Parekh Shubha
Superspeciality

Committee
Apollo Hospital Ethics Submittted/Under
Committee Review
Clinical Research Approved
Ethics Committee,
Medica Superspeciality
Hospital
Ethiclin Independent Approved
Ethics Committee,
Ahmedabad (For Dr A.
D. Parekh)
Medanta-The Medicity Approved

Institutional Review
Board
RTIICS Ethics Submittted/Under
Committee Review

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 1. Patients of eithe
40 Kg of body weig
transplant 4. P
Patients able to tak
negative T-cell cros
Exclusion Criteria
Details 1. Pregnant women
2. Women who do
contraception
3. Recipient of pae
4. WBC count of 2,
cells/mm3 or Hb 6
5. Patients who ha
6. Systemic infectio
7. Patients with act
patients
8. Patients with kno
components of the
9. Malignancy or hi
skin carcinoma
10. Patients receiv
immunosuppressan
11. Patients with ac
GI disorder that mi
12. Patients who d
were already involv
Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
To evaluate that the prevention of acute renal
graft rejection episodes with Mycophenolate MR
Tablets (Panacea Biotec Ltd) when administered
once daily is non inferior to Myfortic (Novartis
Pharmaceuticals Corporation) when
administered twice daily at the end of 12 weeks
of study treatment

To evaluate that the Renal Graft Function with
Mycophenolate MR Tablets (Panacea Biotec
Ltd) when administered once daily is non-inferior
to Myfortic (Novartis Pharmaceuticals
Corporation) when administered twice daily
To evaluate that Safety (Incidences of clinical
and Laboratory AEs) with Mycophenolate MR
Tablets (Panacea Biotec Ltd) when administered
once daily is non-inferior to Myfortic (Novartis
Pharmaceuticals Corporation) when
administered twice daily


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details
Brief Summary Mycophenolate mofetil tablets is being used twice daily in renal transp
patients. Panacea Biotec Ltd has developed a novel modified release
of Mycophenolic acid as Mycophenolate Sodium which is to be taken o
and increasing compliance of patients. The pharmacokinetic studies co
had shown that the Cmax and AUC of the modified release formulation o
Mycophenolate MR are maintained throughout the 24 hours including
period as well. This current trial is planned to evaluate the non inferiori
modified release formulation of Mycophenolate MR (Panacea Biotec L
once daily against the Myfortic (Novartis Pharmaceuticals Corporation
formulation given twice daily.
Mycophenolate mofetil tablets is being used twice daily in renal transp
patients. Panacea Biotec Ltd has developed a novel modified release
of Mycophenolic acid as Mycophenolate Sodium which is to be taken o
and increasing compliance of patients. The pharmacokinetic studies co
had shown that the Cmax and AUC of the modified release formulation o
Mycophenolate MR are maintained throughout the 24 hours including
period as well. This current trial is planned to evaluate the non inferiori
modified release formulation of Mycophenolate MR (Panacea Biotec L
once daily against the Myfortic (Novartis Pharmaceuticals Corporation
formulation given twice daily.

Type of Trial Observational
Type of Study Follow Up Study
Public Title of Study a clinical trial to study the causes of thalamic lesions on brain imaging and its long term
Scientific Title of thalamic lesions: clinical and radiological profile
Study
NIL
Investigator or overall Name ARVIND GUPTA
Trial Coordinator
Designation SENIOR RESIDEN
Affiliation DEPARTMENT OF
MAHARAJ MEDIC
Address DEPARTMENT OF
MAHARAJ MEDIC
ROSEMERRY BLO
SITAPUR ROAD,lu
Lucknow
UTTAR PRADESH
226003
India
Phone 07499438644
Fax
Email drarvindagupt@yah
Details Contact
Person (Scientific Name DR M K SINGH
Query)
Designation PROFESSOR
MAHARAJ MEDIC
MAHARAJ MEDIC
Lucknow
UTTAR PRADESH
226003
India
Phone 09839038491
Fax
Email maneesh_singh@r
Details Contact
Person (Public Query) Name ARVIND GUPTA
Designation SENIOR RESIDEN
MAHARAJ MEDIC
MAHARAJ MEDIC
ROSEMERRY BLO
SITAPUR ROAD,lu
Lucknow
UTTAR PRADESH
226003
India
Phone 07499438644
Fax
Email drarvindagupt@yah
Material Support > CHHATRAPATI SHSHUJI MAHARAJ MEDICAL UNIVERSITY , LUCKNOW, UP
Primary Sponsor
Name CHHATRAPATI SH
Address CHHATRAPATI SH
LUCKNOW, UP
Type of Sponsor Government medic

Sponsor NIL

Recruitment India
Investigator
DR ARVIND GUPTA DEPARTMENT OF
NEUROLOGY,
CHHATRAPATI
SHAHUJI MAHARAJ
MEDICAL
UNIVERSITY ,
LUCKNOW, UP

Committee
chhatrapati shahuji Approved
maharaj medical
university

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details Patients found to h
study
Exclusion Criteria
Details NONE
Random Sequence
Concealment
Blinding/Masking Not Applicable
Disability will be assessed after 6 months of
treatment by GCS, Modified Barthel index scores

DEATH

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details NONE
Brief Summary A PROSPECTIVE OBSERVATIONAL STUDY TO STUDY THE CLINICAL AND RADI
FEATURES OF PATIENTS HAVING THALAMIC LESIONS ON BRAIN IMAGING , DO
MINIMUM 30 PATIENTS OF INDOOR AND OUTDOORS OF DEPARTMENT OF NEU
CSMMU, LUCKNOW , WITH CLINICAL OUTCOME ASSESED AT 3 AND 6 MONTHS

Type of Study Diagnostic
Public Title of Study Causes for white matter changes in Brain imaging
Scientific Title of Etiological profile of Diffuse/multifocal white matter changes in neuroimaging
Study
NIL
Investigator or overall Name Dr prakash kori
Trial Coordinator
Designation senior resident
Affiliation chatrapati shauji m
Address senior resident Dep
medical university
Lucknow
UTTAR PRADESH
226003
India
Phone 7398842297
Fax -
Details Contact
Person (Scientific Name Dr R K Garg
Query)
Designation Professor and head
Address Professor and head
chatrapati shauji m
Lucknow
UTTAR PRADESH
226003
India
Phone 9335901790
Fax -
Details Contact
Person (Public Query) Name Dr R K Garg
Designation Professor and head
Address Professor and head
chatrapati shauji m
Lucknow
UTTAR PRADESH
226003
India
Phone 9335901790
Fax -
Material Support
Material Support > chatrapathi shahuji maharaj medical college university lucknow
Primary Sponsor
Name nil
Address Not applicable
Type of Sponsor Other [Not applicab

Sponsor nil
Recruitment India
Investigator
DR R K Garg Department of
neurology chatrapathi
shahuji maharaj
medical college
university lucknow

Committee
institutional ethics Approved
committe


Intervention / Type
Inclusion Criteria
Gender Both
Details Those patients hav
neuroimaging will b
Exclusion Criteria
Details patients having isc
associated with hyp
Method of Generating
Random Sequence
Method of
Concealment
Blinding/Masking
anti IgM dengue,IgM JE,IgM measles,IgM
herpes simplex which would help identify the
cause of not improvement in white matter
changes

nil

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details not yet
Brief Summary The patients who have been admitted in inpatient department ward and these patients
are found out to have white matter changes on neuroimaging as a part of diagnosis fo
concerned symptoms will be included in our study.These patients will be assessed in
and cause of the disease will tried to e ascertained. To rule out infectious cause and im
cause for white matter lesion serum and cerebrospial fluid examination and infectious
like anti IgM dengue,IgM JE,IgM herpes simplex virus and IgG and Igm anti measles a
be measured. These patients will be treated as per the diagnosis. These patients will b
for 6 months and functional status of the patients will be assessed .

Type of Study Drug
Study Design Randomized, Parallel Group Trial
Public Title of Study Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Le
Complicated Urinary Tract Infection, Including Pyelonephritis
Scientific Title of A Multicenter, Double-blind, Randomized, Phase 3 Study to Compare the Safety and
Study Intravenous CXA 201 and Intravenous Levofloxacin in Complicated Urinary Tract Infec
Including Pyelonephritis

CXA-cUTI-10-05, V2.0 dtd, 4th Jan 2011
NCT01345955
Investigator or overall Name Mr Lokesh Chaudh
Trial Coordinator
Designation trial coordinator for
Affiliation Manager, Clinical O
Address PRA Health Scienc
Marol • Andheri Ea
Mumbai
MAHARASHTRA
400 059
India
Phone 91-22-71234116
Fax 91-22-71234198
Email pandotratarun@pra
Details Contact
Person (Scientific Name Mr Lokesh Chaudh
Query)
Affiliation Manager, of Clinica
Address PRA International M
Mumbai
MAHARASHTRA
400 059
India
Phone 91-22-71234116
Fax 91-22-71234198
Email chaudharilokesh@
Details Contact
Person (Public Query) Name Mr Lokesh Chaudh
Affiliation Manager, Clinical O
Address The Qube • A-602
Andheri (East) • Mu
Mumbai
MAHARASHTRA
400 059
India
Phone 91-22-71234116
Fax 91-22-71234198
Email chaudharilokesh@
Material Support > Cubist Pharmaceuticals Inc 65 Hayden Avenue Lexington, MA 02421
Primary Sponsor
Name Cubist Pharmaceu
Address 65 Hayden Avenue

Sponsor PRA International India

Recruitment Bulgaria
India
Italy
Poland
Spain
Ukraine

Investigator
Dr Sanjay Maitra Apollo Hospitals
Dr Apul Goel Chhatrapati Shahuji

Maharaj Medical
University
Dr Dinesh Jain Dayanand Medical

College & Hospital
Dr Kapil Thakkar Excel Hospital
Dr Manish Ahuja Fortis Hospital - Mohali

Dr Sonal Dalal Gujarat Kidney
Foundation
Dr Hargovind Institute of Kidney

Laxmishanker Trivedi Diseases & Research
Centre
Dr Arun Chawla Kasturba Medical

College & Hospital
Dr Prakash Khetan Shravan Hospital and

Kidney Institute
Dr Mayank Shree Giriraj

Rameshchandra Multispeciality Hospital
Thakker
Dr Vipul Shah Siddhivinayak Hospital

Dr Gokulnath St. Johns Medical
College Hospital

Committee
Central India Medical Approved
Research Ethics
Committee
Drug Trial Ethics Approved
Committee
Ethical Trial Of Health Approved
In Community (ETHIC)
Committee
Ethiclin Independent Approved
Ethics Committee
Ethics Committee, Approved

Apollo Hospitals
Gujarat Kidney Approved
Foundation Ethics
Committee( EC)
Review Board
Institutional Ethics Approved
Committee (IEC)
Kasturba Medical
College & Hospital

Committee (IEC), Fortis
Hospital Mohali
Committee, Chhatrapati
Shahuji Maharaj
Medical University,
Internal Review Board Approved

Shri Giriraj Hospital Approved
Research Ethics
Committee
Status
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 1.Provide written in
procedure not part
representative may
provided this is app
guidelines). 2
years of age 
either: a
postmenopausal fo
bilateral tubal ligati
 b.Of childbea
birth control (e.g., a
of the following me
months prior to stu
partner. Or, subjec
Subjects must be w
the trial and for at l
 4.Males are r
(condom or other b
for at least 35 days
5.Pyuria (white blo
urine or more than
 6.Clinical sig
a.Pyelonephritis, a
 1.Documente
accompanied by pa
 2.Flank pain;
suprapubic tendern
vomiting; OR 
2 of the following:<
worsening symptom
frequency or urinar
temperature more
rigors, chills, or "wa
 4.Costoverte
on physical exam;
At least 1 of the fol
with documented h
urinary catheter tha
therapy and before
that is scheduled to
study therapy and
anatomical abnorm
malformations or n
resulting in at least
pretreatment basel
hours before the st
drug. N
start IV study drug
of the baseline urin
therapy for the trea
Exclusion Criteria
Details 1.Have a documen
hypersensitivity or
antibacterial (Note:
uneventful re-expo
2.Have a concomit
requires non-study
study drug therapy
vancomycin, linezo
3.Receipt of any am
therapy after collec
before administrati
4.Receipt of any do
for the treatment of
study-qualifying pre
subjects with an ac
be enrolled provide
the last dose of the
baseline urine spec
prophylaxis for cUT
consistent with an
other eligibility crite
qualifying baseline
5.Intractable urinar
anticipates would r
6.Complete, perma
7.Confirmed funga
(with more than or
8.Permanent indwe
nephrostomy.
9.Suspected or con
10.Suspected or co
11.Ileal loop or kno
12.Severe impairm
less than 30 mL/mi
hemodialysis or he
output over 24 hou
13.Current urinary
before the EOT (in
study drug adminis
14.Any condition o
Investigator, would
quality of study dat
15.Any rapidly prog
illness including ac
shock.
16.Immunocompro
hematological mali
immunosuppressiv
medications for pre
administration of co
of prednisone per d
days preceding ran
17.One or more of
specimens: asparta
aminotransferase (
bilirubin level great
absolute neutrophi
40,000/, or hemato
18.Participation in
within 30 days prio
19.Previous partici
20.Women who are
Method of Generating Stratified randomization

Random Sequence
Concealment
The proportion of subjects who have both a
per-subject microbiological outcome of
eradication and a clinical outcome of cure.

The number and percentage of subjects in each
treatment group recorded as a clinical cure or
failure or indeterminate
The number and percentage of subjects in each
treatment group recorded as a microbiological
eradication or persistence or indeterminate
Safety will be evaluated in the safety population
by presenting summaries of AEs, laboratory
evaluations, vital signs, and physical
examinations in the 2 treatment groups
For each unique pathogen, the number and
percentage of subjects in each treatment group

recorded as a microbiologic eradication or
persistence for that particular pathogen

Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=

Enrollment (India)
Enrollment (Global)
Trial Months=9
Days=0
Recruitment Status of Completed

Trial (Global)
Trial (India)
Publication Details
Brief Summary Approximately 776 subjects will be enrolled into this study and randomized 1:1 to rece
or comparator (levofloxacin) resulting in 330 subjects per treatment arm. Subject parti
require a minimum commitment of 35 days and a maximum of 42 days. Subjects will b
for the administration of all doses of IV study therapy. A test of cure visit will occur at 7
the last dose of study drug and a late follow-up evaluation or contact will occur a minim
days and a maximum of 35 days after the last dose of study drug.
Arms Assigned Interventions
CXA-201 as treatment for cUTI: Experimental Drug: CXA-201
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201 IV infusion (1500mg q8) for 7 d
Intervention: Drug: CXA-201
Levofloxacin as treatment for cUTI: Active Drug: Levofloxacin
Comparator Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin IV infusion (750mg qd) for 7 days
Intervention: Drug: Levofloxacin
Approximately 776 subjects will be enrolled into this study and randomized 1:1 to rece
or comparator (levofloxacin) resulting in 330 subjects per treatment arm. Subject parti
require a minimum commitment of 35 days and a maximum of 42 days. Subjects will b
for the administration of all doses of IV study therapy. A test of cure visit will occur at 7
the last dose of study drug and a late follow-up evaluation or contact will occur a minim
days and a maximum of 35 days after the last dose of study drug.
Arms Assigned Interventions
CXA-201 as treatment for cUTI: Experimental Drug: CXA-201
CXA-201 IV infusion (1500mg q8) for 7 days CXA-201 IV infusion (1500mg q8) for 7 d
Intervention: Drug: CXA-201
Levofloxacin as treatment for cUTI: Active Drug: Levofloxacin
Comparator Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin IV infusion (750mg qd) for 7 days
Intervention: Drug: Levofloxacin

Drug
Type of Study Drug
Public Title of Study A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
Scientific Title of A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in M
Study Metastatic Castrate-Resistant Prostate Cancer
10TASQ10,Ver4.1with India
spec1.0,2.0,&3.0dated 19Jul2013
NCT01234311
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact
Person (Scientific Name Arun Sundriyal
Query)
Designation Associate Director
Affiliation PPD Pharmaceutic
Address Vatika City Point,11
Gurgaon–122002,I
Gurgaon
HARYANA
122002
India
Phone 91-124-4739903
Fax 91-124-4739999
Email Arun.Sundriyal@pp
Details Contact
Person (Public Query) Name Arun Sundriyal
Address PPD Pharmaceutic
11th Floor,Sector 2
India
Gurgaon
HARYANA
122002
India
Phone 91-124-4739903
Fax 91-124-4739903
Material Support > Active Biotech AB Box 724, Scheelevagen 22 SE-220 07 Lund, Sweden
Primary Sponsor
Name Active Biotech
Address Active Biotech AB
Sweden

Sponsor PPD Pharmaceutical Development India Pvt Ltd

Australia
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Estonia
France
Germany
Greece
India
Ireland
Italy
Latvia
Lebanon
Lithuania
Mexico
Netherlands
New Zealand
Norway
Panama
Peru
Poland
Republic of Korea
Romania
Russian Federation
Slovakia
Spain
Sweden
Taiwan
Turkey
Ukraine
United Kingdom

Investigator
Dr Ginil Kumar Pooleri Amrita Institute of
Medical Sciences
Dr Kim Jacob Mammen Christian Medical

College & Hospital
Dr Bhalchandra Jehangir Clinical
Dattatraya Kashyapi Development Centre
Pvt Ltd
Dr Sunder Lal Tolani Monilek Hospital and

Research Centre
Dr Gouri Shankar Orchid Nursing Home

Bhattacharyya
Dr Shailesh Arjun Shatab

Bondarde Superspeciality
Dr Vanita Noronha Tata Memorial Hospital

Committee
Ethics Committee Approved
Jehangir Clinical
Development Centre
Pvt Ltd

Review Board, Orchid
Nursing Home
Committee - Amrita
Institute of Medical
Sciences

Committee - Shatabdi
Hospital
Committee Monilek
Hospital & Research
Centre

Committee, CMC
Ludhiana
Institutional Review Approved
Board, Tata Memorial
Hospital

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Male
Details 1. Age at least 18 y
of signing the inform
mildly symptomatic
confirmed adenoca
Histologically confi
prostate. <br
radiographic exam
other imaging mod
testosterone (less t
6. Evidence of prog
testosterone have
more than or equal
values as specified
with partner of child
adequate contrace
spermicide or vase
contraceptive meth
patient stops taking
years) of prior mali
squamous cell carc
swallow and retain
the study visit sche
13. Ability to compr
including possible r
investigator and to
 14. Abl
and date the writte
nature and purpose
effects, and given a
understand this info
Exclusion Criteria
Details 1. Prior cytotoxic ch
within 2 years or w
study treatment.
2. Previous antican
including abirateron
weeks prior or sipu
start of study treatm
scan, a new baseli
the radiation therap
3. Previous therapy
weeks for bicalutam
4. Concurrent use
following exception
- Ongoing treatmen
agonists or antago
zoledronic acid) is
stable schedule; ho
compound, or both
5. Any treatment m
prior to the start of
6. Prostate cancer
analgesics or warra
7. Ongoing treatme
anticoagulants is a
monitor before incl
8. Maintenance tre
prednisolone or pre
have been stable fo
9. Systemic exposu
P450 (CYP) 3A4 is
to the start of study
not allowed within 1
10. Ongoing treatm
substrate with narr
treatment.
11. Ongoing treatm
therapeutic range a
12. Simultaneous p
with investigational
investigational drug
treatment.
13. Myocardial infa
coronary syndrome
congestive heart fa
attack, or limb clau
study treatment an
angina, uncontrolle
ventricular arrhythm
14. History of panc
15. Known brain or
16. Known positive
HIV will be exclude
morbidity in an imm
17. Chronic hepatit
disease or cirrhosis
or known viral hepa
hepatitis will be allo
18. Patients with ac
latent TB. (Country
at least 30 days pri
should intend to co
19. Any condition,
or psychiatric cond
which could confou
places the patient a
20. Any patient wh
participate in the st
Random Sequence
Concealment
Blinding/Masking Participant, Investigator and Outcome Assessor Blinded
The primary endpoint is progression-free survival
(PFS) defined as the time from the date of
randomization to the date of radiological
progression or death.

NA


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0
Recruitment Status of Closed to Recruitment of Participants

Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details Not Applicable
Brief Summary This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod i
asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effe
tasquinimod on delaying disease progression compared with placebo.

Type of Study Drug
Public Title of Study A phase-III study to test the therapeutic equivalence, safety and pharmacokinetics of a
formulation of leuprolide acetate versus Lucrin in subjects with locally advanced and m
prostate cancer.
Scientific Title of A randomized, multicenter, phase-III study to test the therapeutic equivalence, safety
Study pharmacokinetics of a new monthly depot formulation (3.75 mg/month) of leuprolide a
(Leuprolide Sun 3.75 mg) versus Lucrin in subjects with locally advanced and metasta
cancer.

CLR_08_10 (v01 Amd 00 dated 13 Oct 2011)
Investigator or overall Name Dr Mudgal Kotheka
Trial Coordinator
Designation Associate Vice Pre
Affiliation Sun Pharma Advan
Address 17/B, Mahal Indust
Mumbai
MAHARASHTRA
400093
India
Phone 912266455645
Fax
Email Clinical.Trials@spa
Details Contact
Person (Scientific Name Dr Mudgal Kotheka
Query)
Mumbai
MAHARASHTRA
400093
India
Phone 912266455645
Fax
Details Contact
Person (Public Query) Name Dr Mudgal Kotheka
Mumbai
MAHARASHTRA
400093
India
Phone 912266455645
Fax
Material Support > Sun Pharma Industries Limited
Primary Sponsor
Name Sun Pharma Indus
Address Acme Plaza, Andh

Sponsor NIL

Recruitment India
Investigator
Dr Suresh Patankar AMAI Chharitable
Trusts ACE Hospital
Dr Sharadchandra Chopda Medicare &
Prasad Research Centre Pvt.
Ltd.
Dr Gensh K Bakhi Dept. of Urology,
Dr Rajeev Sood Dr. Ram Manohar Lohia

Hospital and PGIMER,
New Delhi
Dr Kapil Thakkar Excel Hospital
Dr Raghunath S K HCG Bangalore

Institute Of Oncology
Sampangi Rama
Nagar, Bangalore-
560027
Bangalore
KARNATAKA
Dr Rajendra Shimpi Inamdar Multispeciality Hospital Building S. No,
Hospital 15, Fatima Nagar, Pune
- 411 040, Maharashtra,
India
Pune
MAHARASHTRA
Dr Arun Chawla Kasturba Medical Dept of Urology, Post
College & Hospital, Box 7, Madhava Nagar,
Manipal - 576104.
Udupi
KARNATAKA
Dr Jayesh Dhabalia Lokmanya Tilak Department of Urology

Municipal Medical Dr. Babasaheb
College & Lokmanya Ambedkar Road, Sion
Tilak Municipal General (West), Mumbai -
Hospita, Maharashtra 400022, Maharashtra
Mumbai
MAHARASHTRA
Dr Ramesh D M. S. Ramaiah Medical MSRIT Post, New BEL

College and Hospital Road, Bangalore -
560054, Karnatka
INDIA
Bangalore
KARNATAKA
Dr Ashish Pardeshi Medipoint Hospitals 241/1,New D P

Pvt.Ltd Road,Aundh,Pune-411
007
Pune
MAHARASHTRA
Dr Rajendra K Shimpi Noble Hospital Private 153, Magarpatta City

Limted Road Hadapsar Pune
411013
Pune
MAHARASHTRA
Dr Dilip Dhanpal Sagar Hospital, Department of Urology

Karnataka No. 44/54, 30th Cross,
Tilaknagar, Jayanagar
Extension, Bangalore –
560041 Karnataka
Bangalore
KARNATAKA
Dr Janak Desai Samved Hospital Near Stadium Circle,

Navarangpura -380009
Ahmedabad Gujarat
Ahmadabad
GUJARAT
Dr Anil Mandhani Sanjay Gandhi Post Department of Urology

Graduate Institute of Raebareli Road,
Medical Sciences, UP Lucknow - 226014,
Uttar Pradesh
Lucknow
UTTAR PRADESH
Dr Shreekant N Sushruta Multispeciality PB Road,Vidhyanagar,

Meherwade Hospital & Research
Centre Pvt.Ltd
Dr Hemant Pathak Topiwala National

Medical College & BYL
Nair Hospital
Dr Divakar Dalela Uro Health Research

Center
Dr N K Mohanty V M Medical College &

Safdarjang Hospital,
New Delhi

Committee
Central Ethics Approved
Committee for HCG
Group oh Hospitals (Dr
Raghunath SK)
Ethical Committee, Submittted/Under

Safadarjang hospital (N Review
K Mohanty)
Ethical Review Board Approved
(Dr Ramesh D)
Ethical Trial of Health In Approved
Community (ETHIC)
Committee (Dr Kapil T)
(Surat)

Inamdar Multispeciality
Hospital/Dr. Rajendra
Shimpi/Pune
Ethics Committee Submittted/Under

Samved Review
Hospital/Dr.Janak
Desai/Ahmedabad
Human Ethics Submittted/Under

Committee (Dr GB) Review
Independent Ethics Submittted/Under
Committee (Dr Divakar Review
D) (Lucknow)
Committee (Dr Suresh
P)
Committee for Human Review
Research, Sanjay
Gandhi Post Graduate

Sciences (Dr AM)
Committee, Ram Review
Manohar Lohia Hospital
(Dr Rajeev S)

Committee-Human Review
Research, Lokmanya
Tilak Municipal Medical
College & Lokmanya
Tilak Municipal General
Hospital (Dr JD)

Committee/Dr.Hemant Review
Pathak/Mumbai
Magna -Care Ethics Approved
Committee/Dr.
Sharadchandra
Prasad/Nasik
Manipal University Submittted/Under

Ethics Committee/Dr. Review
Arun Chawla/Manipal
Noble Hospital Approved
Institutional Ethics
Committee (Dr
Rajendra S)
Penta-Med Ethics Submittted/Under

Committee/Dr. Ashish Review
Pardeshi/Pune
Sagar Hospitals Ethics Approved
Committee Human
Research (Dr DD)
Sushruta Hospitals Submittted/Under
Ethics Committee/Dr. Review
Shreekant N
Meherwade/Hubli

Patients
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Male
Details 1.Histologic or cyto
(stage T1-4 N0-3M
testosterone levels
screening. 4.E
5.Estimated life exp
organ and immune
laboratory values, o
creatinine<2.0 mg/
ULN, ALT<5.0 X U
109/L,Hemoglobin
8.Accepts post-the
appropriate birth co
barrier contraceptio
willing to use appro
sterilization, hormo
(partner) or double
Exclusion Criteria
Details 1.Subjects who had
a)An orchiectomy,
b)Undergone any p
the prostate (TURP
screening visit.
2.Subjects who had
a)Prostate cancer t
chemotherapy, imm
modifiers) within 2
b) Luteinizing horm
Leuprolide, Gosere
within 12 months o
months at a time.
c)Androgen recept
Megestrol acetate,
visit.
d)5-alpha-reductas
months prior to scr
e)Investigational dr
3.Subjects with ant
a)Need of concomi
treat flare up reacti
cord compression.
b)Problems for com
protocol, in the opin
4.Subjects with –
a)Evidence of brain
taking into account
symptoms.
b)Clinically significa
cardiovascular diso
coronary vascular p
within 6 months of
c)Any symptoms o
evaluation of local
site (e.g. immuniza
d)Systemic disease
hepatic, respiratory
safe completion of
investigator.
e)Prior or concurre
carcinoma-in-situ o
treated malignancie
are eligible).
f)Active hepatitis, H
g)Active bacterial a
h)Active peptic ulce
i)Known hypersens
of the study medica
j)History of substan
5.Subjects who hav
previous surgery, c

Random Sequence
Method of Other
Concealment
Achieving a total serum testosterone
concentration within the castration range defined
as serum testosterone 50 ng/dl on Day 29 (Week
5)

Additional efficacy assessments (testosterone,
LH, PSA, AP)
Safety and tolerability assessment
Pharmacokinetic evaluation of leuprolide acetate

levels (for a subset of 12 subjects in each arm)


Enrollment (India)
No Date Specified
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary A randomized, multicenter, phase-III, open label, active-controlled, parallel gr
to test the therapeutic equivalence, safety and pharmacokinetics of a new mo
formulation (3.75 mg/month) of leuprolide acetate (Leuprolide Sun 3.75 mg) v
Lucrin in subjects with locally advanced and metastatic prostate cancer. The
objective is to achieve a total serum testosterone concentration within the cas

range defined as serum testosterone 50 ng/dl on Day 29 (Week 5).

Type of Study Drug
Public Title of Study A Clinical study to assess PK properties of Intravenous iron isomaltoside with mean m
weight of 1000 daltons by administering for 500 mg and 1000 mg doses to Inflammato
Disease
Scientific Title of A Open-label pharmacokinetic study of iron isomaltoside 1000 (Monofer®) administer
Study IV bolus injection or 1000 mg intravenous infusion to subjects with Inflammatory Bowe
P-Monofer-PK-IBD-02
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact
Person (Scientific Name Dr Sumbul Siddiqu
Query)
Designation Medical Monitor
Affiliation Max Neeman Inter
Address Max Neeman Inter
Phase-III City: New
Country: India
South
DELHI
110020
India
Phone 91-81-30666357
Fax 91-11-41001945
Email ssiddiqui@neeman
Details Contact
Person (Public Query) Name Dr Shariq Anwar
Designation Director Operations
Affiliation Max Neeman Inter
Address Max Neeman Inter
Phase-III City: New
Country: India
South
DELHI
110020
India
Phone 91-9810979215
Fax 91-11-40548168
Email sanwar@neemana
Material Support > Pharmacosmos A/S
Primary Sponsor
Name Pharmacosmos AS
Address Roervangsvej 30, D

Sponsor Max Neeman International

Recruitment India
Investigator
Dr Abhinav Sharma Capital Urology and
Gastro Hospital
Dr Virendra Singh Gut Endoscopy Clinic
Chowdhury
Dr Rupesh Mehta Mehta Hospital
Dr Shrikant Mukewar Midas MultiSpeciality

Hospital
Dr K Jagan Mohan Rao Nagarjuna Hospital
Dr Vijaya Yenepoya Specialty

Ramachandran Hospital

Committee
Agrasen Ethics Approved
Committee, Agrasen
Hospital 76, Devi
Nagar, New Sanganer
Road, Sodala , Jaipur,
Rajasthan, India
Bhopal Independent Approved

Ethics Committee, 220,
Geeta Nagar,
Bhanpura,
Bhopal-462026,
Madhya Pradesh, India
Centarl India Medical Approved

Research Ethics
committee, Dr.S.M.Patil
Hospital, 2nd
Floor,Yugdharma
Complex, Ramdaspeth,
Nagpur – 440010,
Maharashtra, India
Ethical committee, Approved

Nagarjuna Hospital,
Kanuru,
Vijayawada-520007,
A.P., India
Independent Ethics Approved

Comiittee, 57, Brahmin
Mitra Mandal
Society,B/W Paldi Bus
Stop & Jalaram
Mandir,Paldi
,Ahmedabad -380006,
India
Norms Ethical Approved

Committee, 6-10-425/1,
Bhavani Shankar
Compound, Gundu Rao
Lane,Mannagudda ,
Mangalore-575 003

Intervention /
Comparator Agent Type
Intervention
Intervention
Comparator Agent
Inclusion Criteria
Gender Both
Details 1. Men and women
diagnosed with infl
disease activity (de
Harvey-Bradshaw
(subscore without e
colitis). 3. We
Transferrin saturati
12 months by inves
participate after inf
Exclusion Criteria
Details 1. Anaemia predom
deficiency anaemia
2. Iron overload or
haemochromatosis
3. Drug hypersensi
or iron mono- or dis
4. Known hypersen
drug products.
5. Subjects with a h
6. Active Intestinal
7. Active intestinal
8. Decompensated
Aminotransferase (
9. History of immun
C.
10. Active acute or
judgement and if d
White Blood Cells (
11. Rheumatoid ar
inflammation.
12. Pregnancy and
postmenopausal (a
menstruation), surg
must use one of th
period and after the
biological half-life (
Contraceptive pills,
injections (prolonge
vaginal ring, and tr
13. Extensive activ
14. Planned electiv
15. Participation in
screening
16. Untreated Vitam
17. Other I.V. or or

weeks prior to scre
18. Erythropoietin t
19. Any other medi
may cause the sub
study or place the s
Examples include U
Heart Disease or U

Random Sequence
Centralized
Concealment
To assess PK properties of higher doses (500
mg and 1000 mg) of iron isomaltoside 1000
(Monofer®) in IBD

To establish the effect of iron isomaltoside 1000
(Monofer®) on the reticulocyte count
To establish whether any excretion takes place
in the urine after intravenous administration of
higher doses (500 mg and 1000 mg) of iron
isomaltoside 1000 (Monofer®)
To assess other laboratory measures of iron

status
To obtain safety reassurance with the use of iron



Enrollment (India)
Enrollment (Global)
Trial Months=4
Days=0

Trial (Global)
Trial (India)
Publication Details none as yet
Brief Summary This study is Open-label ph
by 500 mg IV bolus injectio
Disease that will be conducted approximately 3 centers in India.
The primary objective:-
To assess PK properties of higher doses

isomaltoside 1000 (Monofer®) in IBD.
The secondary objectives:-
To establish the effect of iron isomaltoside

reticulocyte count
To establish whether any excretion takes

intravenous administration of higher doses
To assess other laboratory measures of iron status
To obtain safety reassurance with the use

(Monofer®)

Type of Study Ayurveda
Public Title of Study A clinical study to see the effect of some Ayurvedic formulations in the patients of Pros
enlargement.
Scientific Title of Clinical Evaluation of Kanchanara Guggulu and Varuna Kwath Churna in the Manage
Study Benign Prostate Hypertrophy (BPH).
NIL
Investigator or overall Name Dr Pradeep Dua
Trial Coordinator
Designation Research Officer (c
Affiliation Central Council for
Address Central Council for
Jawahar Lal Nehru
Anusandhan Bhaw
Janakpuri-110058
Sciences (CCRAS)
Homoeopathy Anu
Opposite D Block,
West
DELHI
110058
India
Phone 011-28525831
Fax 011-28520748
Email duadrpradeep@gm
Details Contact
Person (Scientific Name Dr Pradeep Dua
Query)
Jawahar Lal Nehru
Anusandhan Bhaw
Janakpuri-110058
Sciences (CCRAS)
Homoeopathy Anu
Opposite D Block,
West
DELHI
110058
India
Phone 011-28525831
Fax 011-28520748
Details Contact
Person (Public Query) Name Dr Pradeep Dua

Jawahar Lal Nehru
Anusandhan Bhaw
Janakpuri-110058
Sciences (CCRAS)
Homoeopathy Anu
Opposite D Block,
West
DELHI
110058
India
Phone 011-28525831
Fax 011-28520748
Material Support > Support in terms of infrastructural facilities: 1. National Institute of Ayurveda (NIA), J
Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola. 3. Shri Dharma
Manjunatheswara (SDM) College of Ayurveda, Hassan.
Primary Sponsor
Name Department of AYU
Government of Ind
Address Department of AYU
Government of Ind
Delhi-110001
Type of Sponsor Government fundin

Sponsor NIL
Recruitment India

Investigator
Dr M K Shringi DrSunil National Institute of
Kanodiya Ayurveda (NIA), Jaipur
Dr Ramesh Arya Dr Rajiv Gandhi

Javad Akther Government
Post-Graduate
Ayurvedic College,
Paprola
Dr P Hemanth Kumar Shri Dharmasthala

Dr Vishwabharathi Manjunatheswara
(SDM) College of
Ayurveda, Hassan

Committee
Committee, National
Institute of Ayurveda
(NIA), Jaipur
Committee, Rajiv
Gandhi Government
Post-Graduate
Ayurvedic College,
Paprola

Committee, SDM
College of Ayurveda,
Hassan, Karnataka,
India

Intervention / Type
Intervention
Comparator Agent
Inclusion Criteria
Gender Male
Details 1. Patients with age
American Urology
21 3. Rectal e
Hypertrophy (BPH)
Specific Antigen (P
<15ml/sec for 2 voi
study for 16 weeks
Exclusion Criteria
Details 1. Patients with sev
2. Patients currentl
BPH/ Hair loss
3. Patients with H/O
4. Serum Prostate
5. Chronic retention
6. Refractory bacte
7. Patients with per
8. Patients with evi
9. Patients with poo
10. Patients with po
11. Patients on pro
corticosteoids, anti
drugs that may hav
100 mm Hg)
12. Patients sufferi
term drug treatmen
Psycho-Neuro-End
13. Patients who h
Coronary Syndrom
Arrhythmia in the la
14. Symptomatic p
15. Patients with co
Aspartate Amino T
Transferase (ALT),
times upper norma
Creatinine >1.2mg/
Bronchial Asthma a
[COPD]), or any ot
16. Alcoholics and/
17. H/o hypersensi
18. Patients who h
trial during the pas
19. Any other cond
jeopardize the stud

Random Sequence
Concealment
• Change in AUA symptom score during the
period of 12 weeks.
• Change in Quality of Life (QOL) Index.

• Reduction in the post voidal residual volume of
urine
• Improvement in Peak urine flow rate.


30/12/2010
Enrollment (India)
Enrollment (Global)

Trial Months=6
Days=0

Trial (Global)
Trial (India)
Publication Details To be published after the completion of the clinical trials in all the three centers.
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Comm
Brief Summary (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.
Kanchanara Guggulu is a poly herbal preparation containing Kanchanara (Bauhinia variegata), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellerica), Amlaki (Phyllanthus emblica), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Varuna (Crata
Tvak (Cinnamomum zeylanicum), Patra (Cinnamomum tamala) and Guggulu (Commiphora wightii).
Varuna Kwath Churna consists of dried stem bark of Crataeva nurvala.
The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of Kanchanara Guggulu and Varuna Kwath Churna, the classical Ayurvedic formulations which have been in use since ages and fou
Hypertrophy and promoting the health.
The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs an
project.

14/02/2014
Type of Study Drug
Public Title of Study A clinical trial to study the safety and efficacy of S-equol in the treatment of Benign Pro
Hyperplasia.
Scientific Title of Randomized, Double-Blind
Study Efficacy and Safety of 4-We
AUS-CT04 Amendment #4, Version 2.5, dated
13 Apr 2012
F.No.CT/124/11-DCG (I)
NCT00962390
Investigator or overall Name Ms Sushma Srikan
Trial Coordinator
Designation Clinical Operations
Affiliation Novotech Clinical R
Address Novotech® Unit# 1
Bangalore,India Su
80 4164 8994 | mo
Bangalore
KARNATAKA
560001
India
Phone
Fax
Email Sushma.Srikanth@
Details Contact
Person (Scientific Name Ms Sushma Srikan
Query)
Address Novotech Clinical R
Prestige Meridian-1
Phone: +91 80 416
Bangalore
KARNATAKA
560001
India
Phone
Fax
Details Contact
Person (Public Query) Name Ms Sushma Srikan
Address Novotech Clinical R
Prestige Meridian-1
Phone: +91 80 416
Bangalore
KARNATAKA
560001
India
Phone
Fax
Material Support > Novotech® Unit# 1103, Level 11 Prestige Meridian-1 29,M.G.Road Bangalore,India
8994
Primary Sponsor
Name Ausio Pharmaceuti
Address 1776 Mentor Ave, S
513-731-1600 513-

Sponsor NIL
Recruitment Australia
India

Investigator
Dr Shams Abdul Kadar Inamdar Multispeciality
Iqbal Hospital,
Dr Ajit Saxena Indraprastha Apollo

Hospitals
DrHKNagaraju M S Ramaiah Memorial
Hospital
Dr Sujata Patwardhan Seth G S Medical

College and KEM
Hospital
Dr Sher Singh Yadav SMS Hospital

Committee
Ethical Review Approved
Board,M.S. Ramaiah
Medical College &
Hospitals, MSR Nagar
New BEL Road, MSRIT
Post, Bangalore
-560054
Ethics committee for Approved

research on Human
Subjects,G. S. Medical
Colllege and KEM
Hospital, Parel, Mumbai
Ethics committee of Approved

SMS Medical college
and attached
Hospitals,SMS Medical
Hospital, JLN Marg,
Jaipur - 302004
Ethics Committee on Approved
Clinical
Trials,Indraprastha
Apollo Hospitals, Sarita
Vihar, Delhi
Ethics Approved
Committee-Inamdar
Multispeciality
Hospital,Inamdar
Multispecialty Hospital,
Pune

Intervention / Type
Comparator Agent
Intervention
Intervention
Inclusion Criteria
Gender Male
Details Inclusion Criteria 1.5
an IPSS ? 13 at Sc
cc/sec and < 15 cc
(and Baseline, if ap
informed consent t
the procedures and
and date an inform
(IEC) before the co
and able to comply
site study staff.
Exclusion Criteria
Details Exclusion Criteria
A patient will not be
exclusion criteria a
1. Has a known his
intolerance to ingre
2. Neurogenic blad
3. Has bladder nec
4. Has acute or chr
5. Has, or has a his
prostate suspected
or has a serum PS
concentration > 4 n
PDF of Trial
ruled out to the satisfaction of the investigator.
6. Has a residual void volume > 250 mL.
7. Has any clinically significant unstable cardiac, respiratory,
neurological, immunological, hematological, hepatic, renal,
endocrine, or gastric disease or any other condition that, in the
opinion of the investigator, could compromise the patient’s welfare,
ability to communicate with the study staff, or otherwise
contraindicate study participation.
8. Shows presence of any manifest premalignant or malignant
disease except treated skin cancers (except melanoma).
9. Has a history of smoking more than 5 cigarettes daily within the
year before
Screening.
10. Has resting systolic blood pressure (BP) > 160 mmHg or BP > 90
mmHg or 11. Has bladder stones as detected by ultrasound.
12. Has hematuria of unknown etiology.
13. Had previous prostate surgery or other invasive treatment for
BPH.
14. Had prior radiation to the pelvis.
15. Has Parkinson’s disease or multiple sclerosis.
16. Had stroke or myocardial infarction within 5 months before
Baseline.
17. Has clinically significant abnormal screening electrocardiogram
(ECG) or unstable
angina or severe congestive heart failure.
18. Has active liver disease with aspartate aminotransferase (AST) >
2 times the upper limit of normal (ULN), alanine aminotransferase
(ALT) > 2 times ULN, unexplained alkaline phosphatase > 3 times
ULN, total bilirubin > ULN, renal insufficiency with creatinine > 1.7
mg/dL, or clinically significant abnormal hemoglobin, white blood cell
count, or platelet count.
19. Has a history of postural hypotension or has a fall in systolic BP
> 20 mm Hg after 2 minutes in a standing position.
20. Received alpha blocker therapy within 28 days before Baseline.
21. Received androgens, anti-androgens, 5-alpha reductase
inhibitors, or luteinizing hormone-releasing hormone (LHRH) analogs
within 3 months before Baseline.
22. Received tricyclic antidepressants or plant extracts (e.g., saw
palmetto) within 1 month before Baseline.
23. Received sedating antihistamines, sympathomimetics, or
anticholinergics within 1 week before Baseline.
24. Has initiated new use (i.e., within the past 4 weeks before
Screening) or otherwise are not on stable doses of
phosphodiesterase-5 inhibitors during the 4 weeks before Screening.
25. Has known or suspected history of alcoholism or drug abuse or
misuse within the last 5 years.
26. Is considered by the investigator, for any reason (including, but
not limited to, the risks described as precautions, warnings, and
contraindications in the current version of the Clinical Investigator’s
Brochure for AUS-131 [S-equol]), to be an unsuitable candidate to
receive the study drug.
27. Has tested positive on the urine drug screen. Patients who test
positive at Screening and can produce documentation from their
physician for the medication that
caused the positive test may be considered for study enrollment at
the discretion of the investigator.
28. Has significant difficulties swallowing capsules or is unable to
tolerate oral
medication.
29. Has participated in another clinical trial or received any
investigational drug or device or investigational therapy within 30
page 5 / 7
days before Screen

Method of Generating Other
Random Sequence
Method of Pre-numbered or coded identical Containers
Concealment
Blinding/Masking Participant and Investigator Blinded
The primary efficacy endpoint is the change from
Baseline in PSA concentration at the Week 4
Visit (V5).

The secondary endpoints are the following: •
Change from Baseline in prostate size (assessed
by transrectal ultrasonography)
• Change from Baseline in Qmax
• Percent of patients with change from Baseline
in Qmax 2 cc/sec
• Percent of patients with change from Baseline
in Qmax 30% • Change from Baseline in PSA
concentration
• Change from Baseline in PSA density


Enrollment (India)
Enrollment (Global)
Trial Months=8
Days=0

Open to Recruitment
Trial (Global)
Trial (India)
Publication Details
Brief Summary The preclinical and clinical data available indicate that AUS-131 is well tolerated and p
acceptable risk-to-benefit ratio to the patient.
Two Phase 1 clinical studies have been completed. An acceptable safety profile was r
both these studies. The TEAE for study drug were similar to placebo and only 2 mild T
(abdominal cramps and nausea) were considered related to study drug for both studie
safety data is blinded it is not known if these TEAE are in the placebo or drug groups.
benefits of a potent ER-? agonist to effectively treat the symptoms of benign prostatic
while providing minimal risk to the patient would be unprecedented.
The PK data from the single dose Phase 1 study AUS-CT01, indicate that, based on t
AUS-131, a BID dosing regimen is appropriate to ensure adequate systemic exposure
state. The PK data from the multidose Phase 1 study, AUS-CT02, confirmed a BID do
is appropriate. The 10, 50, and 150-mg BID doses in the current study are comparable
the dosing regimen in the 14-day AUS-CT02 study with dosing cohorts of 10, 20,
BID. The older individuals (45-65 years) had different PK profiles compared to the
(18-44 years) in the single-dose Phase 1 study, AUS-CT01. However, the safety p
between groups. Dose-normalized AUC0-12 and Cmax were not significantly differ
younger and older age groups, for single and steady state doses in the multidose Ph
AUS-CT02. The safety profile was similar between the older individuals compared
individuals for both studies which suggest the safety profile
for the Phase 2 studies will be similar to those reported in the Phase 1 studies.

Public Title of Study A Clinical Study to Evaluate the Safety and Efficacy of Capsule Outflo in Patients with
Prostatic Hyperplasia
Scientific Title of A Randomized Open Label Dose Determination Clinical Study to Evaluate the Safety
Study of Capsule Outflo in Patients with Benign Prostatic Hyperplasia.
SLS/SAH/01/2012, Version #1.0, Dated 30 July
2012
Investigator or overall Name Dr Shailesh A Shah
Trial Coordinator
Affiliation Bodyline Hospitals
Address Nava Vikas Gruh R
Ahmedabad-38000
Ahmadabad
GUJARAT
380007
India
Phone 079-26651520
Fax 079-26640558
Email shaileshshahuro@
Details Contact
Person (Scientific Name Mr Dipak Patel
Query)
Designation R&D Manager
Affiliation Sahajanand Life Sc
Address Sahajanand Estate
Char-rasta, Ved Ro
Surat
GUJARAT
395004
India
Phone
Fax
Email dipak.patel@sahbi
Details Contact
Person (Public Query) Name Dr Nirav Joshi
Designation Co-investigator
Affiliation Sahana Clinical Re
Address Sahana Clinical Re
cross-roads, Surat
Surat
GUJARAT
395004
India
Phone 9879839644
Fax
Email nirav.joshi@sahan
Material Support > Sahajanand Life Sciences Private Limited
Primary Sponsor
Name Sahajanand Life Sc
Address Sahajanand Estate
Char-rasta, Nani V

Sponsor NIL
Recruitment India
Investigator
Dr Shailesh A Shah Bodyline Hospitals
Dr Gyanendra R Chitale Clinic
Sharma
Dr Rasesh Desai Desai Uroligical and

Maternity Hospital
Dr Vijay D Raghoji Dr. Raghoji Kidney

Hospital and Research
Centre
Dr Ravindra B Sabnis Muljibhai Patel

Urological Hospital
Dr Janak D Desai Samved Hospital

Committee
International Bio Approved
Industry
Open-Innovation
MovEment Independent
Ethics Committee
(IBIOME
IEC)_Ahmedabad_Dr.
Gyanendra Sharma
Industry
Open-Innovation
Ethics Committee
(IBIOME
IEC)_Ahmedabad_Dr.
Janak Desai

Industry
Open-Innovation
Ethics Committee
(IBIOME
IEC)_Ahmedabad_Dr.
Kapil Thakkar

Industry
Open-Innovation
Ethics Committee
(IBIOME
IEC)_Ahmedabad_Dr.
Rasesh Desai

Industry
Open-Innovation
Ethics Committee
(IBIOME
IEC)_Ahmedabad_Dr.
Shailesh A. Shah

Industry
Open-Innovation
Ethics Committee
(IBIOME
IEC)_Ahmedabad_Dr.
Vijay Raghoji
Muljibhai Patel Society Approved

for Research in
Nephro-Urology Ethics
Committee
(MPSRNUEC) Affiliated
to Muljibhai Patel
Urological Hospital

Status from DCGI
Not Applicable

Intervention / Type
Intervention
Inclusion Criteria
Gender Male
Details •Male patients with
with BPH, naïve to
•Patients with Inter
than 7 and less tha
less than 40 cc<br/
 •Patients with
willing to give writte
Exclusion Criteria
Details •Patients with pros
bladder stones; ure
interfere with norm
•Symptomatic coro
events
•Current treatment
(alternative) medic
•Patients with abno
•Any significant dis
the subject
•Patients with drug
•Any psychiatric dis
•Patients who have
months

Random Sequence
Concealment

Change in International Prostate Symptom Score
(IPSS)
Change in Uroloflowmetry parameters

Change in Prostate Volume


Enrollment (India)
No Date Specified
Enrollment (Global)
Trial Months=6
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary This study is a randomized, open label, multi-centric trial comparing th
and efficacy of Capsule OutFlo (1 BD) and OutFlo (2 BD) 75 patients w
Hyperplasia of Prostate. The primary outcome of the trial is to compare
decrease in IPSS in patients taking OutFlo (1BD) vs. OutFlo (2 BD) . P
outcome measures would also include change in Qmax and post void re
urine volume. Reduction in Prostate size from the base-line to the end
study would be noted as a secondary outcome measure.
CTRI/2012/07/002821 [Registered on: 23/07/2012] - Trial Registered Prospectively

Public Title of Study A clinical trial to study the effects of EN3348 (MCC) as compared with Mitomycin C in
intravesical treatment of subjects with BCG recurrent or refractory non-muscle invasiv
cancer
Scientific Title of A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study To Evalua

Study Efficacy And Safety Of EN3348 (MCC) as Compared With Mitomycin C In The Intrave
Treatment Of Subjects With BCG Recurrent Or Refractory Non-Muscle Invasive Bladd

EN3348-303 Amendment 1 Version 2 dated 25
february 2011
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact
Person (Scientific Name Manali Rane
Query)
Designation Project Manager
Affiliation DiagnoSearch Life
Address DiagnoSearch Life
22, Wagle EstateT
Thane
MAHARASHTRA
400604
India
Phone 02267776300
Fax 02267776303
Email manali.rane@diagn
Details Contact
Person (Public Query) Name Manali Rane
Designation Project Manager
Affiliation DiagnoSearch Life
Address DiagnoSearch Life
22, Wagle EstateT
MAHARASHTRA
400604
India
Phone 02267776300
Fax 02267776303
Email manali.rane@diagn
Material Support > Endo Pharmaceuticals Inc
Primary Sponsor
Name Endo Pharmaceuti
Address Endo Pharmaceuti
19317; United Stat

Sponsor DiagnoSearch Life Sciences Pvt Ltd

Recruitment Canada
Germany
India
Netherlands
Poland
United Kingdom

Investigator
Dr Harvinder Singh Chhatrapati Shahuji
Maharaj Medical
University
Dr Kim J Mammen Christian Medical

College & Hospital

Hospital & PGIMER
Dr Desi Gowda M S Ramaiah Medical

Ramesh College and Hospitals
Dr Sunder Lal Tolani Monilek Hospital &

Research Centre
Dr PVLN Murthy Nizams Institute of

Medical Sciences
Dr Sudhir Rawal Rajiv Gandhi Cancer
Institute and Research
Centre
Dr Ganesh Bakshi Tata Memorial Hospital
Dr Jitendra Amlani Urocare Hospital
Dr Nayan Kumar V. M. Medical College &

Mohanty Safdarjang Hospital
Dr Kalyan Kumar Woodlands

Sarkar Multispeciality Hospital
Limited

Committee
Ethical Committee, Approved
V.M. Medical College &
Safdarjang Hospital
Ethical Review Board, Approved
M.S. Ramaiah Medical
College & Teaching
Hospital, Bangalore

Woodlands
Multispecialty Hospital
Limited, Kolkata
Human Ethics Approved

Committee, Tata
Memorial Hospital,
Mumbai
Human Ethics Approved
Committee, Tata
Memorial Hospital,
Mumbai

Committee , Dr. Ram Review
& PGI MER, New Delhi

Committee, Chhatrapati
Shahuji Maharaj
Medical
University(Erstwhile
King Goerges Medical
University), Lucknow

Committee, Christian
Medical College &
Hospital, Ludhiana

Committee, Monilek
Hospital & Research
Center, Jaipur
Institutional Review Approved

Board, Rajiv Gandhi
Cancer Institute &
Research Centre, New
Delhi
NIMS Institutional Approved

Ethics Committee,
Nizam’s Institute of
Medical Sciences,
Hyderabad
Wellcare Research Approved

Ethics Committee,
Urocare Hospital,
Rajkot

Intervention / Type
Intervention
Comparator Agent
Inclusion Criteria
Gender Both
Details Subjects are eligibl
criteria are met:<br
or older at time of c
or refractory NMIBC
evidence of persist
CIS) at least 6 mon
with or without mai
Recurrent disease
achieving a tumor-
course of BCG1 wi
months. Subjects w
18 months followin
course of BCG is d
instillations of BCG
strength. 3. H
2004 WHO classifi
a. High grade Ta p
papillary lesion(s) (
muscularis propria)
tumor(s) of any gra
resectable CIS lesi
randomization 
including follow-up
Eastern Cooperativ
grade of 2 or less<
involving the upper
extravesical work u
biopsy) within 6 mo
work up occurred m
extravesical work u
order to determine
child-bearing poten
post-menopausal f
effective contracep
study and be willing
after their last dose
and give written inf
Exclusion Criteria
Details Subjects meeting t
participation in the
1. Current or previo
2. Current or previo
metastatic bladder
3. Current evidence
adenocarcinoma o
4. Currently receivi
(cytotoxic/cytostatic
5. Currently receivi
. 6. Current or prior
7. Systemic immun
8. Treatment with a
lives from randomiz
9. Prior treatment w
3 months of
randomization, exc
immediately post-T
10. Prior treatment
cell wall compositio
11. Refractory to M
following minimum
12. Contraindicatio
13. Untreated urina
14. ANC 1000/µL a
15. Known cardiov
within the past 3 m
failure (New York H
uncontrolled cardia
16. Female subject
17. Congenital or a
18. Current or histo
any organ system (
years (with the exc
the ureter treated w
adequately treated
or asymptomatic no
successfully treate
receiving hormone
19. Bladder contrac
for a minimum of 1
20. Inability to toler
surgical manipulati
21. Clinically signif
22. Any medical or
investigator, would
protocol or comple

Random Sequence
Concealment
The primary objective of this study is to evaluate
the efficacy of EN3348 as compared with
mitomycin C in the treatment of subjects with
BCG recurrent or refractory NMIBC
Outcome
The secondary objective is to evaluate the safety
of EN3348 as compared with mitomycin C in the
treatment of subjects with BCG recurrent or
refractory NMIBC.


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details Not applicable
Brief Summary This is a phase 3 randomized, active-controlled, open-label, multicenter study
conducted in approximately 120 investigational sites worldwide. Subjects with
recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will
for participation in this study. Refractory disease is defined as failure to achie
tumor-free status by 6 months of initiation of adequate BCG therapy (minimum
weekly doses of BCG (induction) followed by a second course (induction or m
in which subject received a minimum of 2 doses).
Recurrent disease is defined as reappearance of disease after achieving a tu
status by 6 months after initiation of adequate BCG therapy. Subjects with re
disease must have recurred within 18 months following the last dose of BCG.
Approximately 450 subjects will be randomized. The randomization will be 1:1
stratified by geographic region (North America, India, Europe), tumor patholo
versus no CIS), prior BCG response (refractory versus recurrent), and prior in
(IVe) chemotherapy (yes/no).
The study will consists of 4 phases: Screening phase of 6 weeks, induction p
weeks, maintenance phase of 10 months and follow up phase of up to approx
months.
This is a phase 3 randomized, active-controlled, open-label, multicenter study
conducted in approximately 120 investigational sites worldwide. Subjects with
recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will
for participation in this study. Refractory disease is defined as failure to achie
tumor-free status by 6 months of initiation of adequate BCG therapy (minimum
weekly doses of BCG (induction) followed by a second course (induction or m
in which subject received a minimum of 2 doses).
Recurrent disease is defined as reappearance of disease after achieving a tu
status by 6 months after initiation of adequate BCG therapy. Subjects with re
disease must have recurred within 18 months following the last dose of BCG.
Approximately 450 subjects will be randomized. The randomization will be 1:1
stratified by geographic region (North America, India, Europe), tumor patholo
versus no CIS), prior BCG response (refractory versus recurrent), and prior in
(IVe) chemotherapy (yes/no).
The study will consists of 4 phases: Screening phase of 6 weeks, induction p
weeks, maintenance phase of 10 months and follow up phase of up to approx
months.

Interventional
Nutraceutical
Public Title of Study This study is to see the safety tolerability and efficacy of study medication (Dose I & II
placebo in subjects with Benign Prostatic Hyperplasia
Scientific Title of An exploratory double-blind placebo controlled randomized parallel group multi-centric
Study evaluate the safety tolerability and efficacy of LinumLife EXTRA (Dose I & II) compare
in subjects with Benign Prostatic Hyperplasia

VL/0702174/FR, Version 1.3, Date: 16-07-2008
Investigator or overall Name Dr Navneet Sonaw
Trial Coordinator
Designation Trial Coordinator
Affiliation Vedic Lifesciences
Address Vedic Lifesciences
Andheri (W), Mumb
Mumbai
MAHARASHTRA
400053
India
Phone 02242025706
Fax
Email navneet.s@vediclif
Details Contact
Person (Scientific Name Dr Navneet Sonaw
Query)
Andheri (W), Mumb
MAHARASHTRA
400053
India
Phone 02242025706
Fax
Details Contact
Person (Public Query) Name Dr Navneet Sonaw
Andheri (W), Mumb
MAHARASHTRA
400053
India
Phone 02242025706
Fax
Material Support > Frutarom Netherlands BV, Landjuweel 5, 3905 PE Veenendaal, The Netherlands.
Primary Sponsor
Name Frutarom Netherlan
Address Landjuweel 5 3905
Type of Sponsor Other [Nutraceutica

Sponsor NIL
Recruitment India

Investigator
Dr Umesh Khanna Lancelot Kidney and GI
Centre
Dr Mukund G Andankar B.Y.L.Nair charitable

Hospital and Topiwala
Medical College
Dr Rajesh Shrotri Shrotri Urology
Dr Chetan Patil Muktai Hospital

Dr Raju Uttamani Shraddha Hospital
Dr Milind Bapat Sardesai Clinic

Committee
B.Y.L NAIR CH
Hospital Mumbai - Dr.
Mukund Andankar
Committee Mumbai -
Dr. Chetan Patil
Committee Mumbai -
Dr. Milind Bapat
Committee Mumbai -
Dr. Rajesh Shrotri
Committee Mumbai -
Dr. Raju Uttamani
Committee Mumbai -
Dr. Umesh Khanna

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Male
Details • Ages eligible for S
eligible for Study :
Fresh cases) diagn
of BPH (frequency;
etc) • America
Score ? 13. •
ng/ml) • Resid
voiding 
Exclusion Criteria
Details Subjects on 5 –alp
adrenergic antagon
Subjects on combin
alpha-blockers(K/c
Subjects on anti-ch

Random Sequence
Concealment
• Change in the American Urological Symptom
Index Score
• Change in the Post Voiding Residual Urine
volume in all treatment groups


Enrollment (India)
No Date Specified
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details None
Brief Summary Benign Prostatic Hyperplasia (BPH) is associated with bothersom
urinary tract symptoms (LUTS) that affect quality of life by interfe
normal daily activities and sleep patterns. The prevalence of both
symptoms also increases with age. Treatment of BPH is currentl
undergoing intense scrutiny due to the cost and morbidity {comp
and disability due to the procedure associated with the “gold stan
treatment, Transurethral Resection of the Prostate (TURP)} but t
with bladder neck incision are costly and have adverse effects in
bleeding, infection and sexual dysfunction such as retrograde eja
and may not be required in less severe cases. Hence it is the ne
to look out for oral medications for BPH with minimal side effects
a need to develop other treatments, especially for subjects unfit f
or with less severe symptoms. The modern drugs do provide sym
relief to the patient, which is the most important target to be achi
these subjects. In the present study, the aim is to assess these
formulations as a supportive therapy for symptoms of BPH and a
same time to determine their efficacy. In this study we are trying
evaluate these herbal formulations and monitor whether the Inve
Product (IP) LinumLife Extra (two active doses) can maintain and
provide greater symptomatic relief to subjects with BPH

Type of Trial Observational
Type of Study Cross Sectional Study
Study Design Other
Public Title of Study To compare the Ischemic stroke and Hemorrhagic stroke
Scientific Title of To study the outcome of hospitalization in patients of Ischemic stroke Vs Hemorrhagic
Study retrospective Observational study
MAX/RETRO-STR Version: 1.1 Dated June 1,
2012
Investigator or overall Name Dr JD Mukherji
Trial Coordinator
Designation Senior Consultant
Affiliation Max Super Special
Address Max Super Special
Delhi 110017 Max
Saket New Delhi 1
South
DELHI
110017
India
Phone 9810950742
Fax
Email jd.mukherji@maxh
Details Contact
Person (Scientific Name Karan Sharma
Query)
Designation Clinical research T
Delhi 110017 Max
Saket New Delhi 1
South
DELHI
110017
India
Phone 9711252764
Fax
Email krnsharma87@gm
Details Contact
Person (Public Query) Name Dr JD Mukherji
Designation Senior Consultant
Delhi 110017 Max
Saket New Delhi 1
DELHI
110017
India
Phone 9810950742
Fax
Email jd.mukherji@maxh
Material Support > NA
Primary Sponsor
Name NA
Address NA
Type of Sponsor Other [NA]

Sponsor NIL
Recruitment India

Investigator
Dr JD Mukherji Max Super Speciality
Hospital, Department of
Neurology, West Block

Committee
Max Healthcare Ethics Approved
Committee, Max Super
Speciality Hospital

Health Type
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details All Ischemic and H
Department of Neu
Delhi 
Exclusion Criteria
Details 1. Patients undergo
2. Patients of SAH.
3. Incomplete patie

Random Sequence
Concealment
1. To determine the disability/death in patients of
ischemic stroke and hemorrhagic stroke, using
mRS or/and BI, at admission and discharge, in a
retrospective observational study.

1. To determine the disability, recovery in
ischemic stroke patients, after thrombolysis with
tPA and non-thrombolysed patients.
2. To determine the relation of factors namely,
age, hypertension, diabetes mellitus, old stroke,
coronary artery disease, smoking, alcohol, GCS
on admission, treatment, on the outcome of
hospitalization in patients of ischemic stroke and
hemorrhagic stroke.

Total Sample Size=114
Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=2
Days=0

Trial (Global)
Trial (India)
Publication Details "None Yet"
Brief Summary As the morbidity and the re
each other, this retrospect
disability on discharge/
This is a retrospective obse
of Neurology of Max Supe
Primary objective is to s
1. All Ischemic and H
Neurology, Max super Specialty Hospital, Saket, New Delhi
2. Exclusion Criteria
1. Patients undergoing Neuro-surgical management
2. Patients of SAH.
3. Incomplete patient clinical data


Public Title of Study A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifi
Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss d
Androgen-Deprivation Therapy
Scientific Title of A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifi
Study Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss d
Androgen-Deprivation Therapy

20080560 - Protocol amendment 3 dated 25
June 2013
NCT00925600
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact
Person (Scientific Name Sagar Patil
Query)
Affiliation Amgen Technology
Address A Wing, Level 4,Dy
400059 India
Mumbai
MAHARASHTRA
400059
India
Phone 912267869351
Fax 91-22-67869138
Email psagar@amgen.co
Details Contact
Person (Public Query) Name Dr Veena Jaguste
Designation Dir Development O
Affiliation Amgen Technology
Address A Wing, Level 4, D
Mumbai,India
Mumbai
MAHARASHTRA
400059
India
Phone 91-22-67869353
Fax 991-22-67869138
Email vjaguste@amgen.c
Material Support > Amgen Inc
Primary Sponsor
Name Amgen Technology
Address A Wing, Level 4, D
Mumbai | India | PI
Type of Sponsor Other [Global Biote

Sponsor none
Australia
Austria
Belgium
Bulgaria
Canada
Colombia
Croatia
Cyprus
Czech Republic
Denmark
Estonia
France
Germany
Greece
Hong Kong
Hungary
Iceland
Ireland
Israel
Italy
Latvia
Lithuania
Luxembourg
Malta
Mexico
Netherlands
Norway
Peru
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom

Investigator
Dr Kim Mammen Christian Medical
college Hospital
Dr Rajnish Nagarkar Curie Manavata Cancer
Centre
Dr Raghunath SK HCG-Bangalore
Institute of Oncology
Dr Abhay Mahajan Sai Urology Hospital

Committee
Christian Medical Approved
College and Hospital,
Ludiana - Institutional
ethics committee
HCG - Central Ethics Approved

committee,
HCG-Bangalore
Institute of Oncology
Manavata Clinical Approved

Research institute
Professional Ethics
Committee
Sai Urology Hospital Approved

Ethics Committee - Dr
Abhay
Regulatory Clearance
Status from DCGI Status

Approved/Obtained
Health Type
Patients
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Male
Details Men more than 30
 Have underg
GnRH agonists and
months ECO
(6/12 or 0.5 on the
at 4 meters in one
Density (BMD) req
lumbar spine, total
years of age: BMD
neck -2.5 At least 2
Exclusion Criteria
Details Screening LOCS II
4.0 for cortical cata
Bone Mineral Dens
hip andor femoral n
evidence of distant
Known osteonecro
Unstable system d
hypertension, unsta
myocardial infarctio
Incisional eye surg
Current administra
PSA 5ngmL at scre

Random Sequence
Concealment
Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Subject incidence of lens opacification event
development or progression by month 12, based
on a change of ? 1.0 in P, ? 1.0 in C, or ? 0.7 in
NO in the LOCS III score.

development or progression by month 6, based
on a change of ? 1.0 in P, ? 1.0 in C, or ? 0.7 in

NO in the LOCS III score
Adverse event incidence and changes in safety
analytes.


Enrollment (India)
Enrollment (Global)
Trial Months=3
Days=0

Trial (Global)
Trial (India)
Publication Details None
Brief Summary This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new
lens opacifications in subjects with non-metastatic prostate cancer receiving denosum
loss due to androgen deprivation therapy.
Summary of results:
This study was conducted at 125 centers in 18 countries: Australia, Bulgaria, Canada, the Czech Republic, France, Greece, Hungary, India, Latvia, Mexico, New Zealand, Poland, Russia, Slovak
Africa, Ukraine, and the United States.
The first participant enrolled on 30 November 2009 and the last participant enrolled on 04 May 2015.
Participants were randomly assigned to receive denosumab or placebo in a 1:1 allocation ratio. Randomization was stratified on the basis of screening Lens Opacities Classification System (LOC
versus ? 3.0 at any site); age group (< 75, ? 75 years), and patient-reported history of cataract (yes/no).

Type of Study Drug
Public Title of Study A clinical trial to study the effects Adjuvant Axitinib in patients at High Risk of Recurren
Carcinoma
Scientific Title of Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 St
Study Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC
AP311736, Version 6 dated January 31, 2013
NCT01599754
Investigator or overall Name Dr Shrikant P Kasa
Trial Coordinator
Designation Clinical Project Ma
Affiliation IQVIA RDS (India)
Address 301-A-1,Leela Bus
Mumbai-400059
Mumbai
MAHARASHTRA
400059
India
Phone 09920287330
Fax 022-66466475
Email Shrikant.Kasawlek
Details Contact
Person (Scientific Name Dr Shoibal Mukher
Query)
Designation Vice President, Me
Address 8th Floor, DLF Squ
Gurgaon, Haryana
Gurgaon
HARYANA
122002
India
Phone 91-7838652395
Fax
Email shoibal.mukherjee@
Details Contact
Person (Public Query) Name Suchela Srivatsa
Designation Director – Clinical O
Address 301-A-1, Leela Bus
400059
Mumbai
MAHARASHTRA
400059
India
Phone 91-9820712114
Fax 91-22-56774343
Email suchela.srivatsa@q
Material Support > SFJ Pharma Ltd. II Boundary Hall, 2nd Floor, Cricket Square, PO Box 2681, Grand
KY1-1111, Cayman Islands, on behalf of Pfizer Inc., 235 E, 42nd street, New York
Primary Sponsor
Name SFJ Pharma Ltd II
Address Boundary Hall, 2nd
Cayman, KY1-1111
42nd street, New Y

Sponsor Quintiles Research India Private Limited

Recruitment China
Democratic People's Republic of Korea
Hong Kong
India
Japan
Taiwan

Investigator
Dr Tanveer M Maksud Bharat Cancer Hospital
& Research Institute
Dr V Satya Suresh Attili BIBI General Hospital &

Cancer Centre
Dr Pavithran Keechilat Department of Medical

Oncology, Amrita
Sciences and Research
Center
Dr SVSS Prasad Department of Medical

Oncology, Apollo
Health City
Dr Ranjan Kumar Department of Medical

Mohapatra Oncology, Apollo
Speciality Hospital 600035, Tamil Nadu,

India.
Chennai
TAMIL NADU
Dr Chanchal Goswami Department of 71/1, Humayun Kabir
Oncology, B.P. Poddar Sarani, New Alipore,
Hospital & Medical Block – G, Kolkata –
Research Ltd 700053,West Bengal,
India
Kolkata
WEST BENGAL
Dr Krishna Prasad Department of Attavar, Mangalore -
Oncology, Kasturba 575001, Karnataka,
Medical College India
Hospital Dakshina Kannada
KARNATAKA
Dr Boman Dhabhar Department of Aga Hall, Nesbit Road,

Oncology, Prince Aly Mazagaon, Mumbai –
Khan Hospital 400010, Maharashtra,
India
Mumbai
MAHARASHTRA
Dr Donald J Fernandes Department of Shirdi Sai Baba Cancer

Radiotherapy & Hospital & Research
Oncology, Shirdi Sai Centre (A Unit of
Baba Cancer Hospital & Kasturba Hospital),
Research Centre Madhav Nagar, Manipal
– 576104, Karnataka,
India
Udupi
KARNATAKA
Dr Kim Mammen Department of Urology, Christian Medical

Christian Medical College & Hospital,
College & Hospital Ludhiana - 141008,
Punjab, India
Ludhiana
PUNJAB
Dr Apul Goel Department of Urology, King George’s Medical

King George’s Medical University, Chowk,
University Lucknow – 226003,
Uttar Pradesh Uttar
Pradesh, India
Lucknow
UTTAR PRADESH
Dr Bhalchandra Jehangir Clinical Jehangir Hospital

Kashyapi Development Centre Premises, 32 Sassoon
Private Limited Road, Pune – 411001,
Maharashtra, India
Pune
MAHARASHTRA
Dr Chiramana Haritha M.S. Patel Cancer Shree Krishna Hospital

Centre & Medical Research
Centre, Gokal Nagar,
Karamsad – 388325,
Gujarat, India
Anand
GUJARAT
Dr Murali Krishna Mahatma Gandhi 1/7, MVP Colony,

Voona Cancer Hospital & Visakhapatnam –
Research Institute
Dr Amit Rauthan Manipal Hospital
Dr Amit Bhargava Moolchand Kharaiti

Ram Hospital &
Ayurvedic Research
Dr Minish Mahendra Ruby Hall Clinic

Jain
Dr Anish Maru SEAROC Cancer

Centre
Dr Shailesh Arjun Shatabdi Super

Bondarde Speciality Hospital

Committee
Ethical Committee, B.P. Approved
Poddar Hospital &
Medical Research Ltd.,
71/1, Humayun Kabir
Sarani, Block- G, New
Alipore, Kolkata –
700053, West Bengal-
Dr. Chanchal Goswami
Ethical Trial of Health In Approved
Community (ETHIC)
Committee, Shop No:16
(B), 3rd floor, Sheetal
Shopping Square,(Old
LB Cinema), Ghod
Dod- Bhatar Road
Junction, Surat-395001,
Gujarat- Dr. Tanveer M.
Maksud
Ethics Committee of Submittted/Under

Manipal Hospitals, Review
Manipal Hospital, 98,
HAL Airport Road,

Bangalore-560017,
Karnataka- Dr. Amit
Rauthan
Ethics Committee, Approved 17/05/2012
Apollo Hospitals, Apollo
Health City, Jubilee
Hills,
Hyderabad-500096,
Andhra Pradesh- Dr.
SVSS Prasad
Human Research Approved 04/06/2012

Ethics Committee, H M
Patel Centre for
Medical Care And
Education,
Karamsad-388325,
Gujarat- Dr. Chiramana
Haritha
Institutional Ethics Approved 13/04/2012

Committee – Poona
Medical Research
Foundation, 40,
Sassoon Road, Pune –
411001, Maharashtra-
Dr. Minish Mahendra
Jain
Institutional Ethics Submittted/Under No Date Specified
Committee, Amrita Review
Sciences and Research
Centre, Ponekkara P.O,
Kochi-682041, Kerala-
Dr. Pavithran Keechilat

Committee, BIBI
General Hospital &
Cancer Centre,
16-3-991/1/C,
Government Printing
Press Road, Malakpet,
Hyderabad – 500024,
Andhra Pradesh- Dr. V.
Satya Suresh Attili

Committee, Christian
Medical College &
Hospital, Ludhiana-141
008,Punjab- Dr. Kim
Mammen
Institutional Ethics Submittted/Under No Date Specified

Committee, Office of Review
the Research Cell,
Chhatrapati Shahuji
Maharaj Medical
University, Chowk,
Lucknow-226003, Uttar
Pradesh- Dr. Apul Goel
Institutional Review Approved 21/05/2012
Board , Mahatma
Gandhi Cancer Hospital
& Research Institute,
1/7, M.V.P.Colony,
Visakhapatnam-530017
, Andhra Pradesh- Dr.
Murali Krishna Voona
Institutional Review Submittted/Under No Date Specified
Board, Prince Aly Khan Review
Hospital,Aga Hall,
Nesbit Road,
Mazagaon, Mumbai –
Dr. Boman Dhabhar
Jehangir Clinical Approved 21/04/2012

Development Centre
Board, Jehangir
Hospital Premises, 32,
Sassoon Road, Pune -
Dr. Bhalchandra
Kashyapi
Manipal University Approved 12/07/2012

Ethics Committee,
Madhav
Nagar,Manipal-576104,
Karnataka- Dr. Donald
J Fernandes
Manipal University Approved 10/05/2012

Ethics Committee,
Madhav
NagarManipal-576104,
Karnataka- Dr. Krishna
Prasad
Moolchand Medcity Not Applicable No Date Specified

Review Board,
Moolchand Kharaiti
Ram Hospital &
Ayurvedic Research,
Institute, Moolchand
Medcity Hospital,Lajpat
Nagar III, Main Ring
Road,New Delhi –
110024- Dr. Amit
Bhargava
SEAROC Ethics Submittted/Under No Date Specified

Committee, SEAROC Review
Cancer Centre, S.K.
Soni Hospital, Sect -5
Vidhyadhar Nagar,
Sikar Road, Jaipur –
302013, Rajasthan- Dr.
Anish Maru
Shatabdi Super Approved 20/04/2012

Speciality Hospital
Committee, Shatabdi
Super Speciality
Hospital, Suyojit City
Centre, Opp.
Mahamarg Bus Stand,
Mumbai Naka, Nashik –
Dr. Shailesh Arjun
Bondarde


Patients
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 1.Male or female, a
than or equal to 20
diagnosed utilizing
following: a.T
Fuhrman’s grade 3
to1 b.T3 N0 o
to 1 - T3a inva
greatest dimension
Fuhrman’s grade a
Fuhrman’s grade a
histologically confir
clear cell RCC.<br/
macroscopic residu
must not have rece
chemotherapeutic,
RCC. 6.Patien
anti-angiogenic tre
organ function defi
more than or equal
or equal to 75,000
or equal to 9.0 g pe
multiplied by upper
than or equal to 1.5
less than or equal t
clearance (Clcr) mo
Cockcroft-Gault eq
using Scr: Clcr (mL
by weight (in kilogr
dL)}). The cal
for female gender.<
dipstick. If dipstick
protein:urine creati
may enter only if U
Cycle 1 Day 1, no e
as documented by
hour apart. The sys
than or equal to 14
readings must be le
hypertension is con
eligible. 9.Wo
adequate contrace
for women include
contraceptives, intr
partner who has be
Acceptable contrac
vasectomy for at le
spermicide. 1
(ICD) indicating tha
has been informed
enrollment. 11
visits, treatment pla
procedures. 
Exclusion Criteria
Details Patients presenting
the trial:
1.Histologically und
duct carcinoma, lym
sites.
2.National Cancer
Adverse Events (C
date of randomizat
3.Diagnosis of any
of randomization, e
cancer, or in situ ca
adequately treated
months.
4.Any of the followi
administration: myo
coronary/periphera
heart failure, cereb
and 6 months for d
5.Gastrointestinal a
inability to take ora
requirement for intr
prior surgical proce
resection
treatment for active
active gastrointesti
hematemesis,
hematochezia or m
resolution
documented by en
malabsorption synd
6. Current use or a
known potent CYP
ketoconazole, itrac
nefazodone, nelfina
7. Current use or a
known CYP3A4/5 o
dexamethasone, p
phenobarbital, and
8. Requirement of
antagonists. Low-d
low-dose anticoagu
venous access dev
allowed. Therapeu
9. Active seizure di
cord compression,
10. A serious unco
would impair their a
11.Known human i
immunodeficiency
12.Pregnancy or br
potential must have
to date of randomiz
13.Dementia or sig
the understanding
with the requireme
14.Other severe ac
laboratory abnorma
study participation
the interpretation o
investigator would
study.
15.Receipt of any i
investigational anti
16.Current treatme
care trials or non-tr
(PRO) methods stu

Random Sequence
Concealment
Disease Free Survival DFS based on the IRC
review of tumor assessments is the primary
endpoint in this study.

over all Survival (OS) will be compared between
Arm A and Arm B DFS based on the investigator
tumor assessments will also be analyzed as a
secondary endpoint


Enrollment (India)
24/04/2012
Enrollment (Global)
Trial Months=0
Days=0
Trial (Global)
Trial (India)
Publication Details None yet
Brief Summary This is a prospective, randomized, double-blind placebo controlle
3 trial of oral axitinib starting at 5 mg twice daily given up to 3 yea
placebo. The dose may be increased or decreased depending on
individual patient tolerance of axitinib. The Primary Objective of t
is to demonstrate an improvement in disease free survival (DFS)
patients at high risk of recurrent RCC randomly assigned to adju
axitinib (Arm A) vs. Placebo (Arm B) after nephrectomy.
Type of Study Drug
Public Title of Study Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hos
Adults With Complicated UTIs (Urinary Tract Infections).
Scientific Title of A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group,
Study Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CA
Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Tr
Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Ne
Pathogen in Hospitalized Adults.

D4280C00002 dated 08 May 2012
NCT01595438
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact
Query)
11th Floor, Sector
122002 India
Gurgaon
HARYANA
122002
India
Phone 911244739903
Fax 911244739999
Details Contact
11th Floor, Sector
122002 India
Gurgaon
HARYANA
122002
India
Phone 911244739903
Fax 911244739999
Material Support > AstraZeneca AB, S-151 85 Södertälje, Sweden
Primary Sponsor
Name AstraZeneca AB
Address S-151 85, Sodertal

Sponsor NIL

Belgium
Brazil
Bulgaria
Croatia
Czech Republic
France
Germany
Greece
India
Israel
Japan
Mexico
Poland
Republic of Korea
Romania
Russian Federation
Taiwan
Ukraine

Investigator
Dr Deepak Bolbandi Apollo Hospitals
Dr Rajagopal Vallivayai Apollo Hospitals

Enterprise Limited
Dr Bhagyesh Care Institute of

Ashwinkumar Shah Medical Sciences
(CIMS) Hospital Private
Limited
Dr Jaydeep Date Deenanath Mangeshkar

Hospital and Research
Centre
Dr Sanjay Kumar Department of
Kochar
Dr Shriniwas Ambike Jehangir Clinical

Development Centre
Pvt Ltd
Dr Arun Chawla Kasturba Medical

College and Hospital
Dr Jyothsna Guttikonda Star Hospitals (Unimed

Health Care Pvt. Ltd.)
Dr Parikh Kandarp Sterling Hospital

Priyakant
Committee
Apollo Hospitals Approved
Jehangir Clinical
Development Centre
Pvt Ltd
Ethics Committee of Approved

Care Institute of
Medical Sciences
Ethics Committee, S. P. Approved
Medical College & AG
Hospitals(PBM)
Hospital

Committee Apollo
Hospitals
Committee Kasturba
Medical College and
Hospital

Committee Star
Hospitals
Committee-Deenanath Review
Mangeshkar Hospital
and Research Centre
Sterling Hospital Ethics Approved

Committee

Patients
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 18 to 65 years of a
participate if they a
females capable of
pregnancy while re
days after. <b
WBCs and has a p
containing greathe
recognized uropath
(CAZ-AVI and dorip
pyelonephritis or co
Exclusion Criteria
Details Urine pathogen is a
resistant to CAZ-AV
Patient urine cultur
microorganisms re
confirmed fungal U
Patient is receiving
transplant.
Patient is immunoc
Patient is considere
period or has a rap

Random Sequence
Concealment
1.The proportion of patients with resolved (or
return to premorbid) UTI(Urinary Tract
Infection)symptoms except flank pain and
resolution or improvement in flank pain based on
patient-reported symptom assessment response.
2.The proportion of patients with a per patient
microbiological eradication and resolution (or
return to premorbid) of all UTI-specified

symptoms based on patient-reported symptom
assessment response.

The proportion of patients with a favorable per
patient microbiological response in the
microbiological modified Intent-To-Treat analysis
set.

patient microbiological response in the
microbiologically evaluable analysis set.
patient microbiological response in the extended
microbiological evaluable analysis set.
The proportion of patients with resolution (or
return to premorbid) of all UTI-specific symptoms
based on the patient-reported symptom
assessment response in the microbiological
modified Intent-To-Treat analysis set.
The proportion of favorable per-pathogen

microbiological response in the microbiological
modified Intent-To-Treat analysis set.
microbiological response in the microbiologically
evaluable analysis set.
microbiological response in the extended
The proportion of patients with an
investigator-determined clinical cure in the
microbiological modified Intent-To-Treat analysis
set.

extended microbiologically evaluable analysis
set.

clinically evaluable analysis set.
The favorable per pathogen microbiologic
response by categories of minimum inhibitory
concentration in the microbiological modified
Intent-To-Treat analysis set.

concentration in the microbiologically evaluable
analysis set.

concentration in the extended microbiologically
evaluable analysis set.
The proportion of patients with favorable

investigator clinical response assessment in
patients infected with a ceftazidime resistant
pathogen in the microbiological modified
The proportion of patients with an 21 to 25 days after study drug s
investigator-determined clinical cure in patients
infected with a ceftazidime resistant pathogen in
the microbiologically evaluable analysis set.
The proportion of patients with an 21 to 25 days after study drug s

investigator-determined clinical cure in patients
the extended microbiologically evaluable
analysis set.
The proportion of patients with favorable 21 to 25 days after study drug s

per-patient microbiological response for patients
the microbiological modified Intent-To-Treat
analysis set.

the microbiologically evaluable analysis set.

the extended microbiologically evaluable
analysis set.
The proportion of patients with symptomatic Day 5 and 21 to 25 days after s

resolution (defined in the coprimary variables) for
patients infected with a ceftazidime resistant
pathogen in the microbiological modified
The time to first defervescence while on IV Any time after start of study dru
(intravenous)study therapy in patients in the (intravenous) study therapy, wh
microbiological modified Intent-To-Treat analysis of 5 days to a maximum of 14 d
set who have fever at study entry. therapy.
(intravenous) study therapy in patients in the (intravenous) study therapy, wh
microbiologically evaluable analysis set who of 5 days to a maximum of 14 d
have fever at study entry. therapy.
extended microbiologically evaluable analysis of 5 days to a maximum of 14 d
set who have fever at study entry. therapy.
clinically evaluable analysis set who have fever of 5 days to a maximum of 14 d
at study entry. therapy.
Profile of pharmacokinetic (PK) of the individual Anytime within 15 minutes prior

components of CAZ-AVI (avibactam and stopping study drug, anytime be
ceftazidime)- maximum plasma concentration minutes after stopping study dr
(Cmax). Cmax - Maximum plasma concentration. between 300 minutes and 360
stopping study drug.
components of CAZ-AVI (avibactam and stopping study drug, anytime be
ceftazidime)- minimum plasma concentration minutes after stopping study dr
(Cmin). Cmin - Minimum plasma concentration. between 300 minutes and 360
components of CAZ-AVI (avibactam and

ceftazidime)- area under the plasma
concentration time curve at steady state
(AUCss). AUCss - Area under the plasma
concentration time curve at steady state.
Profile of pharmacokinetic (PK) of the individual

components of CAZ-AVI (avibactam and
ceftazidime)- terminal half-life (t½ ). t½ -
Terminal half-life.


Enrollment (India)
Enrollment (Global)
Trial Months=5
Days=28

Trial (Global)
Trial (India)
Publication Details
Brief Summary The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compare
Doripenem for treating hospitalized patients with complicated urinary tract infections, i
acute pyelonephritis.

Type of Study Surgical/Anesthesia
Public Title of Study A Clinical trial to compare the events that occur during and after surgery,between the
laparoscopic(key hole) approches,RETROPERITONEAL VS TRANSPERITONEAL AP
the removal of entire kidney,in the treatment of renal tumors.
Scientific Title of A Comparitive study of perioperative outcomes of retroperitoneoscopic vs transperiton

Study laparoscopic Radical nephrectomy in Renal cell carcinoma-A Randomized controlled
IEC.NO.07/13/2012/MCT
Investigator or overall Name DR VENUGOPAL
Trial Coordinator
Designation PROFESSOR
Affiliation GOVT MEDICAL C
Address Dr. G. VENUGOPA
COLLEGE POST P
SPECIALITY BLOC
Thiruvananthapura
KERALA
695011
India
Phone 09447055070
Fax
Email drgvenugopal@yah
Details Contact
Person (Scientific Name DR NAVIN CHRIST
Query)
Affiliation govt medical colleg
Address Gurukripa kesava g
senior resident dep
college
Thiruvananthapura
KERALA
695011
India
Phone 09895552073
Fax
Email navinchristopher.an
Details Contact
Person (Public Query) Name DR NAVIN CHRIST
Affiliation govt medical colleg
Address 2/1120(9),gurukripa
post senior residen
medical college thi
Thiruvananthapura
KERALA
695011
India
Phone 09895552073
Fax
Email navinchristopher.an
Material Support > STATE BOARD OF MEDICAL RESEARCH, GOVT. MEDICAL COLLEGE HOSPITA
THIRUVANANTHAPURAM-695011
Primary Sponsor
Name DR G VENUGOPA
Address PROFESSOR, DE
BLOCK, GOVT. ME
THIRUVANANTHA
Type of Sponsor Other [PRINCIPAL

Sponsor DR NAVIN CHRISTOPHER A

Recruitment India
Investigator
DR G VENUGOPAL GOVT. MEDICAL
COLLEGE HOSPITAL

Committee
HUMAN ETHICAL Approved
COMMITTEE, GOVT.
MEDICAL COLLEGE, T
HIRUVANANTHAPURA
M-695011

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details All participants of a
Hospital, Thiruvana
(CT) evidence of R
give consent to par
Exclusion Criteria
Details History of prior maj
BMI greater than 3

Random Sequence
Concealment
Blinding/Masking Participant and Outcome Assessor Blinded
To Assess the difference in operative blood loss
and post operative analgesia requirement
between the two laparoscopic procedures.
To assess the difference in occurrence of
perioperative complications between the two
laparoscopic procedures.

To assess the difference in duration of stay in
the hospital for the patients undergoing these
two laparoscopic procedures.
To assess the difference in duration of surgery,
renal artery and renal vein control time between
the two laparoscopic procedures.

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details NONE YET
Brief Summary A randomized controlled trial, double blind, parallel group, single tertiary care centre s
comparing the perioperative outcomes of retroperitoneoscopic vs transperitoneal lapa
radical nephrectomy done in patients with renal cell carcinoma. Study conducted in Go
College Hospital, Thiruvananthapuram. Estimated sample size 40, 20 in each arm. Ex
duration of study is 2 years.
Primary Objectives
To Assess the difference in operative blood loss and post operative analgesia req
the two laparoscopic procedures.
To assess the difference in occurrence of perioperative complications between th
procedures.
Secondary Objectives
To assess the difference in duration of stay in the hospital for the patients undergoing these two laparoscopic procedures.
To assess the difference in duration of surgery, renal artery and renal vein control time between the two laparoscopic procedures.

Type of Trial PMS
Type of Study Drug
Study Design Other
Public Title of Study Prospective Observational Study of Once-Daily Tamcontin® Tablet (Continus® Contro
tablet of Tamsulosin Hydrochloride, 0.4 mg) in the Treatment of Lower Urinary Tract S
Secondary to Benign Prostatic Hyperplasia (BPH) in the Routine Clinical Practice
Scientific Title of Prospective Observational Study to Assess the Safety and Efficacy of Once-Daily Tam
Study Tablet (Continus® Controlled release tablet of Tamsulosin Hydrochloride, 0.4 mg) in t
of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia (BPH) in
Clinical Practice

CCS/TAM/12/v.2
Investigator or overall Name Dr Harbans Singh
Trial Coordinator
Designation Chief Urologist
Affiliation R. G. Urology and
Address R. G. Urology and
Pitampura, Delhi
North West
DELHI
110034
India
Phone
Fax
Email harbanspruthi@ho
Details Contact
Person (Scientific Name Dr Harbans Singh
Query)
Pitampura, Delhi
DELHI
110034
India
Phone
Fax
Details Contact
Person (Public Query) Name Dr Harbans Singh
Pitampura, Delhi
DELHI
110034
India
Phone
Fax
Material Support > Modi-MundiPharma Pvt. Ltd.
Primary Sponsor
Name ModiMundiPharma
Address Umesh Modi Group
110019 (India)

Sponsor Not Applicable
Recruitment India

Investigator
Dr Dinesh Suman Noble Medicare
Dr Harbans Singh R. G. Urology and
Laparoscopy Hospital
Dr Manish Singla R. G. Urology and

Dr Pankaj Wadhwa R. G. Urology and

Dr R L Nayak Sama Nursing Home
Dr Ashok K Gupta Urology Clinic
Dr Sudhir Khanna Urology Clinic

Committee
SPECT ERB, Delhi Approved

Health Type
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Male
Details Newly diagnosed, t
Tamsulosin hydroc
Exclusion Criteria
Details Not Applicable

Random Sequence
Concealment
To assess the safety and efficacy of once-daily
Tamcontin® tablet (Continus® controlled release
tablet of Tamsulosin hydrochloride, 0.4 mg) in
the treatment of lower urinary tract symptoms
secondary to Benign Prostatic Hyperplasia in the
routine clinical practice

Not Applicable

Phase of Trial Post Marketing Surveillance

Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0

Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details None Yet
Brief Summary The present study is aimed at generating prospective data on the safety and efficacy o
0.4 mg tablet manufactured and marketed by Modi-Mundipharma Pvt. Ltd. in the routin
practice. The BA/BE (bioavailability/ bioequivalence) studies of the product have show
night time plasma concentration can be attained if the tablet is dosed at 9 pm while als
an optimal plasma concentration of the drug over a 24 hr. time-period. This may be du
controlled drug release formulation of Tamcontin®. This in turn could lead to a better m
of the symptoms of BPH especially nocturia which is a major clinical problem faced by
patients. Through this study we aim to correlate the results of BA/BE studies with the c
outcomes (chronotherapeutic benefit) in BPH patients.

11/11/2013
Type of Study Drug
Public Title of Study A Study to assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liqui
in Patients 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
Scientific Title of A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration St
Study the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinat
in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity

2011-000330-11
905-CL-047 dated 22 March 2012
NCT01565694
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact
Query)
Designation Associate Director-
Point, 11th Floor, S
Gurgaon
HARYANA
122002
India
Phone 911244739903
Fax 911244739999
Email arun.sundriyal@pp
Details Contact
Designation Associate Director-
Point, 11th Floor, S
Gurgaon
HARYANA
122002
India
Phone 911244739903
Fax 911244739999
Email arun.sundriyal@pp
Material Support > Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden,The Netherlands
Primary Sponsor
Name Astellas Pharma E
Address Astellas Pharma E
Netherlands

Sponsor PPD Pharmaceutical Development India Pvt Ltd

Recruitment Belgium
Brazil
Canada
Denmark
France
Germany
India
Mexico
Netherlands
Poland
Republic of Korea
Russian Federation
Turkey
United Kingdom

Investigator
Dr Shailesh Anantray Bodyline Hospitals
Shah

Hospital & PGIMER
Dr Shobha Lal Himalayan Institute of

Sukhdarshan Medical Sciences
Dr Shimpi Rajendra Inamdar Multispeciality

Kashinath Hospital

Committee
Ethics Approved
Committee-Inamdar
Multispeciality Hospital
(PI-Dr Rajendra Shimpi)

Committee-Dr. Ram Review
& PGIMER (PI- Dr
Rajeev Sood)

Committee-HIHT
university (PI- Dr
Shobha Lal)
Spandan Independent Submittted/Under
Ethics Review
Committee-Bodyline
Hospital (PI- Dr
Shailesh Shah)


Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details Documented diagn
Practicing clean int
treatment with an a
Exclusion Criteria
Details Known genitourina
incontinence.
Bladder augmentat
Current Faecal imp
Electro-stimulation
any time during the
Subjects with the fo
complete obstructio
at risk of gastric ret
Reflux grade 3 or 4
Current urinary trac
Subject has severe
than 30 ml/min).
Subject has severe
than 9).
Subject has receive
prior to screening.

Random Sequence
Concealment
Change from baseline in maximum cystometric
capacity (MCC)

Change in Maximum Cystometric Capacity
(MCC)
Change in Urodynamics
Measured by:
Bladder compliance (Change in V per Change in
Pdet).
Bladder volume until first detrusor contraction
(greater than 15 cmH2O).
Bladder volume at 30 cm H2O detrusor
pressure.
Bladder volume at 40 cm H2O detrusor
pressure.
Number of uninhibited detrusor contractions
(greater than 15 cmH2O) until leakage or
maximum 135 percentage of age-related bladder
capacity. Detrusor pressure at leakage or 135
percentage of age-related cystometric capacity.
Change in Diary Observations

Measured by:
Average catheterized volume per catheterization.
Maximum catheterized volume per day.
Mean number of incontinence episodes per 24
hours.
Number of dry (incontinence-free) days per 7
days.
Change in Quality of Life

Total Sample Size=74

Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0

Trial (Global)
Trial (India)
Publication Details NA
Brief Summary The purpose of this study is to investigate a medicine for the treatment of symptoms a
complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
occurs in patients with spina bifida or other spinal cord damage where the bladder mu
more than normal during filling. These patients often have an inability to void, so that c
is required to empty the bladder.
The medicine being tested in this study is called solifenacin succinate. Solifenacin tab
to adults for the treatment of overactive bladder. A new liquid suspension has been de
treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension will be investigated. The take-up
time that the solifenacin suspension stays in the body will also be investigated during
The study will last for approximately 12 months, where completing patients will receive
continuous treatment.
Effectiveness will be measured by urodynamics (the filling and emptying of the bladde
volumes measured during catheterization together with the diary responses relating to
of incontinence episodes or incontinence free days.
Safety assessments include analysis of the blood and urine, review of the ECG, ultras
kidney, simple memory and understanding tests (cognitive function) and the ability to s
far objects (visual accommodation).
Study has been discontinued in India.
No Subjects were screened or enrolled for the study in India.
The purpose of this study is to investigate a medicine for the treatment of symptoms a
complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
occurs in patients with spina bifida or other spinal cord damage where the bladder mu
more than normal during filling. These patients often have an inability to void, so that c
is required to empty the bladder.
The medicine being tested in this study is called solifenacin succinate. Solifenacin tab
to adults for the treatment of overactive bladder. A new liquid suspension has been de
treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension will be investigated. The take-up
time that the solifenacin suspension stays in the body will also be investigated during
The study will last for approximately 12 months, where completing patients will receive
continuous treatment.
Effectiveness will be measured by urodynamics (the filling and emptying of the bladde
volumes measured during catheterization together with the diary responses relating to
of incontinence episodes or incontinence free days.
Safety assessments include analysis of the blood and urine, review of the ECG, ultras
kidney, simple memory and understanding tests (cognitive function) and the ability to s
far objects (visual accommodation).
Study has been discontinued in India.
No Subjects were screened or enrolled for the study in India.
PDF of Trial
n, 08 Jan 2023 04:53:11 GMT)
l Registered Prospectively
n Early Parkinsons Disease (P05664 AM4)

Active-Controlled Dose-Range-Finding
h Early Parkinsons Disease (Phase 3
Identifier
ClinicalTrials.gov
Protocol Number
Details of Principal Investigator
Details Contact Person (Scientific Query)

Dr Monisha Sharma
Medical Director
MSD Pharmaceuticals Pvt Ltd
6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon
HARYANA 122002 India
Gurgaon
HARYANA
122002
India
91-124-4647300
911244375561
monisha_sharma@merck.com
Details Contact Person (Public Query)
DrMonisha Sharma
Director Clinical Research India
MSD Pharmaceuticals Pvt Ltd
Gurgaon
HARYANA
122002
India
91-124-4647300
page 1 / 8
PDF of Trial
911244375561
Source of Monetary or Material Support
00 Whitehouse Station, NJ 08889-0100
Primary Sponsor Details
Merck Sharp and Dohme
One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100
USA
Pharmaceutical industry-Global
Address
8th Floor, Platina, Plot No. C 59, G Block,
Bandra Kurla Complex, Bandra E, Mumbai 400
098
me of Site Site Address Phone/Fax/Email
MS All India Institute of 91-11-26588886

Medical Sciences madhuribehari@hotmail
(AIIMS), Room no. .com
3074, 3rd floor,
Teaching block, New
Delhi – 110029 INDIA
South
DELHI
Brain and Mind Institute B-101, Neeti Gaurav 91-9822722132

Complex, Ramdaspeth, drmeshram@hotmail.co
Nagpur – 440010, m
Nagpur
page 2 / 8
PDF of Trial
MAHARASHTRA
kilaben Dhirubhai Rao Saheb Achutrao 912230666666
mbani Hospital Patwardhan Marg, Four drmbhatt@gmail.com
Bungalows, Andheri
(West) 400053
Mumbai
MAHARASHTRA
vai Medical Center 3209, Avanashi Road, 91-9842155101

d Hospital Limited Coimbatore – 641014 kalyani_vijayan@rediff
Tamil Nadu, India mail.com
Coimbatore
TAMIL NADU
S Ramaiah Medical Dept of Neurology New 91-80-23608888

llege and Hospitals BEL Road MSRIT Post drrsrinivasa@hotmail.c
Bangalore 560054 om
Bangalore
KARNATAKA
Mallikatta Neuro Centre Opp. Mallikatta Circle, 91-9845080925
Kadri Mangalore – shankarmnl@hotmail.c
575002 om
Uttara Kannada
KARNATAKA
ax Super Speciality Max Super Speciality 91-9971545666

spital Hospital 1, Press shankarmnl@hotmail.c
Enclave Road, Saket om
New Delhi – 110 017
New Delhi
DELHI
rkinson’s & Ageing No. 58 C/12, Micro 91-8025599190

search Foundation, Labs Compound, Kudlu umuthane@usa.net
Village, Singasandra
Post, Hosur Main Road,
Bangalore – 560068
Bangalore
KARNATAKA
ee Chitra Tirunal All India Institute of 91-471-2524268

titute for Medical Medical Sciences Ashakishore99@gmail.
iences & Technology (AIIMS), Room no. com
3074, 3rd floor,
Thiruvananthapuram,
Kerala- 695011, INDIA
Thiruvananthapuram
KERALA
aya Health Centre OPD Block, Room No.1 91-44-24814261

and 2 Neuro Lab and doc_suresh@yahoo.co
Neuro Clinic 175, NSK m
Salai, Vadapalani
Chennai 600026 INDIA
Chennai
TAMIL NADU
proval Status Date of Approval Is Independent Ethics

Committee?
proved 18/01/2012 No
bmittted/Under No Date Specified No

view
page 3 / 8
PDF of Trial

view
Date
19/03/2012
Condition
Idiopathic Parkinsons Disease
Parkinsons disease
Name Details
Preladenant (SCH 420814) Each morning: 2, 5, or 10 mg
preladenant tablet + placebo
capsule Each evening
(approximately 8 hours after the
morning dose): 2, 5, or 10 mg
preladenant tablet. Total
duration of treatment will be 52
weeks (26 weeks in each part of
the study)
Placebo for Preladenant Each morning: placebo tablet +

placebo capsule Each evening
(approximately 8 hours after the
morning dose):placebo tablet.
Subjects randomly assigned to
this group will receive placebo
twice daily for the first 26 weeks
(Part 1) and will be re-assigned
to receive preladenant 5 mg
twice daily for the second 26
weeks (Part 2).
Rasagiline Each morning: placebo tablet +

1 mg rasagiline capsule Each
evening (approximately 8 hours
after the morning dose):placebo
tablet. Total duration of
treatment will be 52 weeks (26
weeks in each part of the study)
Inclusion Criteria
30.00 Year(s)
85.00 Year(s)
Both
 • Each subject must have a diagnosis of idiopathic PD for less
than 5 years based on the United Kingdom Parkinson’s
Disease Society Brain Bank Criteria and the inclusion/exclusion
criteria for this protocol. a. Each subject should have
bradykinesia and at least one of the following symptoms: •
Each subject who is receiving amantadine and/or anticholinergics
page 4 / 8
ttp://ctri.nic.in
page 5 / 8
PDF of Trial
to Randomization. • Cardiovascular Disease: A subject
must not have had any clinically significant cardiovascular event
or procedure for 6 months prior to Randomization, including,
but not limited to, myocardial infarction, prolonged QTc interval
[a subject must not have a QTcF result > 500 msec], angioplasty,
unstable angina, or heart failure; and a subject must not have
heart failure staged New York Heart Association Class III or
IV. • Liver Enzymes: A subject must not have an alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) ³3
x the upper limit of normal (ULN) or total bilirubin (T-BIL) ³1.5 x ULN.
 • Liver Disease: A subject must not have active
serologically confirmed hepatic dysfunction (defined as viral
infection [Hepatitis B, C, or E; Epstein-Barr virus {EBV};
cytomegalovirus {CMV}]) or a history of diagnosis of drug- or
alcohol-induced hepatic toxicity or frank hepatitis. • A
subject must not have a history within the past 5 years of a primary
or recurrent malignant disease with the exception of adequately
treated basal cell or squamous cell skin cancer, in situ cervical
cancer, or in situ prostate cancer with a normal
prostate-specific antigen (PSA) post resection. • Prohibited
Concomitant Medications: A subject must not have received any
treatment listed in the protocol • A subject must not need to
continue to receive any treatment listed in the table below during the
trial, unless expressly prescribed by the investigator during the
trial. • A subject must not have an average daily
consumption of more than three 4-ounce glasses (118 mL) of 
wine or the equivalent. • A subject must not have poorly
controlled diabetes (eg, HbA1c >8.5) or significantly abnormal
renal function (eg, creatinine >2.0 mg/dL) in the opinion of the
investigator. • A subject must not have a severe or ongoing
unstable medical condition (eg, any form of clinically significant
cardiac disease, symptomatic orthostatic hypotension, seizures, or
alcohol/drug dependence). • A subject must not have
participated in any studies using preladenant. • A subject must
not have allergy/sensitivity to investigational products or their
excipients. • A female subject must not be breast-feeding or
considering breast-feeding. • A female subject must not be
pregnant or intending to become pregnant. • A subject must not
have any clinically significant condition or situation, other than the
condition being studied that, in the opinion of the investigator,
would interfere with the trial evaluations or optimal participation
in the trial. • A subject must not have used any investigational
drugs within 90 days immediately before Screening. • A subject
must not have been participating in any other clinical trial within 90
days, inclusive, of signing the informed consent form of the
current trial. • A subject must not be a member or a family
member of the personnel of the investigational or sponsor staff
directly involved with this trial. 
Exclusion Criteria
- Must not have a form of drug induced or atypical Parkinsonism,
cognitive impairment(ie, Montreal Cognitive Assessment [MoCA]
score less than 22), bipolar disorder, untreated major depressive
disorder, schizophrenia, or other psychotic disorder; history of
exposure to a known neurotoxin, or any neurological features not
consistent with the diagnosis of PD as assessed by the investigator.
- Must not have had surgery for PD.
- Must not have a history of repeated strokes with stepwise
progression of Parkinsonism or head injuries, or a stroke within 6
page 6 / 8
ttp://ctri.nic.in
page 7 / 8
PDF of Trial
- Must not have allergy/sensitivity to investigational product(s) or

its/their excipients.
- Must not be breast-feeding, considering breast-feeding, pregnant or
intending to become pregnant.
- Must not have used preladenant ever, or any investigational drugs
within 90 days immediately before Screening.
me Timepoints
Baseline and Week 26
me Timepoints
e only for Completed/Terminated trials

only for Completed/Terminated trials
be 26 weeks in duration. The objective of

nt for the treatment of early Parkinson’s
enant.
atment groups: preladenant 2 mg
g bid, rasagaline 1 mg once-daily (qd) or
ctly into Part 2 and will remain in the same
1 with the exception of subjects who were
acebo in Part 1 will be administered 5 mg
ment groups: Preladenant 2, 5 or 10 mg
page 8 / 8
PDF of Trial
n, 08 Jan 2023 04:53:26 GMT)

7037 (Study P06153 AM3)

Double?Dummy Extension Study of
sons Disease
Identifier
ClinicalTrials.gov
Protocol Number

Dr Monisha Sharma
Director- Clinical Research, India
MSD Pharmaceuticals Pvt Ltd.
Gurgaon
HARYANA
122002
India
91-124-4647300
91-124-4375561
Dr Monisha Sharma
Director- Clinical Research, India
MSD Pharmaceuticals Pvt Ltd.
Gurgaon
HARYANA
122002
India
91-124-4647300
91-124-4375561
page 1 / 8
PDF of Trial
& Co., Inc. (hereafter referred to as the
itehouse Station, NJ 08889-0100, U.S.A

Merck Sharp Dohme
One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100
USA
Address
Fulford (India) Limited, 8th Floor, Platina Plot No.
C-59, G-Block Bandra-Kurla Complex, Bandra
(E), Mumbai 400098
page 2 / 8
PDF of Trial
kilaben Dhirubhai Medical Research 91-22-30666666

mbani Hosp.& Med. Department,Room No. drmbhatt@gmail.com
search Institute 19,15th Floor,Kokilaben
Dhirubhai Ambani
Hosp.& Med. Research
Inst. Rao Saheb
Achutrao Patwardhan
Marg Four Bunglows,
Andheri West 400053
Mumbai (Suburban)
MAHARASHTRA
zam Institute of Department of 91-40-23320332

edical Sciences Neurology,Room No. meenaak@hotmail.com
329/A,3rd floor, Nizams
Sciences Panjagutta
500082
Hyderabad
ANDHRA PRADESH
D.Hinduja National Neurology Department, 91-22-24447179
spital & Medical Room No. 2107, 2nd charusankhla@gmail.co
search Centre Floor, P.D. Hinduja Nat. m
Hospital & Med.
Research Centre Veer
Savarkar Marg 400163
Mumbai
MAHARASHTRA
rkinson’s & Ageing Room No. 6 (Drug Trial 91-80-25599190

search Foundation Room,2nd Floor, umuthane@usa.net
Parkinsons and Aging
Research Foundation
Panjagutta 500082
Hyderabad
ANDHRA PRADESH
ee Chitra Tirunal Neuro Pharmacology 91-471-2524400

titute for Medical Women Disorder ashakishore99@gmail.c
iences & Technology Section, om
Basement,Sree Chitra
Tirunal Institute for
Medical Sciences &
Technology SCTIMST
P. O. 695011
Thiruvananthapuram
KERALA
Johns Medical Department of 080-22065780

llege Hospital Neurology, 3rd Floor, grk_sarma@yahoo.com
Sarjapur Road
Koramangala
Bangalore, 560034,
KARNA
Bangalore
KARNATAKA
aya Health Centre OPD Block, Room No.1 044-24814261

& 2, 175 NSK Salai, doc_suresh@yahoo.co
Chennai, TAMILNADU, m
600026
page 3 / 8
PDF of Trial
Chennai
TAMIL NADU
Committee?
t Applicable No Date Specified No
Date
19/06/2012
Condition
Parkinson Disease
Parkinsons disease
Name Details
Preladenant (SCH 420814) 2, 5, or 10 mg Preladenant
tablets, given orally twice daily
for 40 weeks
Rasagiline 1 mg Rasagiline tablet given
orally once a day for 40 weeks
Inclusion Criteria
30.00 Year(s)
85.00 Year(s)
Both
- Participants who have completed the 12-week treatment period of
the parent trial, P04938 or P07037. - Participants must be
willing and able to provide written informed consent for P06153.
 - Participants must be able to adhere to dose and visit
schedules. - Participants must be taking levo-dopa (L-dopa).
 - Participants may be taking additional adjunct PD medications
(e.g., dopamine agonists, entacapone). - Each participant must
have results of clinical laboratory tests (hematology, blood
chemistries, and urinalysis) within normal limits or clinically
acceptable to the investigator as evidenced by the last available test
results from the parent study (P04938 or P07037), and no results fall
within the parameters for exclusion described below in the exclusion
criterion for liver-related findings. - There has been no change
in, or there has been no finding to warrant checking, serology status
page 4 / 8
PDF of Trial
(for cytomegalovirus [CMV], Epstein-Barr virus [EBV], and Hepatitis

B, C, and E). - Each participant must have results of a physical
examination within normal limits, including blood pressure, within
normal limits or clinically acceptable limits to the investigator, and not
within the parameters for exclusion described below in the exclusion
criterion for blood pressure. - All participants who are sexually
active or plan to be sexually active agree to use a highly effective
method of birth control while the participant is in the study and for 2
weeks after the last dose of study drug. A male participant must not
donate sperm within 2 weeks after the last dose of study drug.
Exclusion Criteria
Exclusion Criteria:
- Any participant who discontinued from P04938 or P07037 for any
reason.
- Any participant with a severe or ongoing unstable medical condition
(e.g. any form of clinically significant cardiac disease symptomatic
orthostatic hypotension seizures or alcohol/drug dependence).
- Any participant with a history of poorly controlled diabetes (e.g.
HbA1c greater than 8.5) or significantly abnormal renal function (e.g.
creatinine greater than 2.0 mg/dL) in the opinion of the investigator.
- As a continuation of the liver-related withdrawal criteria from the
parent studies (P04938 and P07037) any participant with elevated
values for alanine aminotransferase (ALT) aspartate
aminotransferase (AST) or total bilirubin (T BIL) as evidenced by the
most recent chemistry panel results in the parent study meeting any
one of the following criteria:
- ALT or AST greater than 8 x upper limit of normal (ULN).
- ALT or AST greater than 5 x ULN for more than 2 weeks.
- ALT or AST greater than 3 x ULN and (T-BIL greater than 2 x ULN
or international normalized ratio [INR] greater than 1.5 that is not due
to anti-coagulation) at the same visit.
- ALT or AST greater than 3 x ULN with the appearance of
worsening fatigue nausea vomiting right upper quadrant pain or
tenderness fever rash and/or eosinophilia (greater than 5%).
- As a continuation of the blood pressure (BP) withdrawal criteria
from the parent study (P04938 or P07037) any participant meeting
the following criteria for the second of two consecutive visits
separated by 7 days (i.e. the participant met one of the BP criteria
once already 7 days before the P06153 screening visit):
- Systolic BP greater than or equal to 180 mm Hg or diastolic BP
greater than or equal to 105 mm Hg or
- An elevation from baseline BP in the parent study (P04938 or
P07037) of systolic BP greater than or equal to 40 mm Hg or
diastolic BP greater than or equal to 20 mm Hg.
- A participant must not have a history within the past 5 years of a
primary or recurrent malignant disease with the exception of
adequately treated basal cell or squamous cell skin cancer in situ
cervical cancer or in situ prostate cancer with a normal
prostate-specific antigen (PSA) post resection.
- Any participant with an average daily consumption of more than
three 4-ounce glasses (118 mL) of wine or the equivalent.
- A participant must not have received certain prespecified
medications or ingested high tyramine-containing aged cheeses (e.g.
Stilton) for a prespecified time window before the trial during the trial
and for 2 weeks after the trial.
- Any participant with allergy/sensitivity to the investigational
products or their excipients.
- Any female participant breast feeding or considering breast feeding.
- Any female participant pregnant or intending to become pregnant.
- Any participant with any clinically significant condition or situation
page 5 / 8
PDF of Trial
other than the condition being studied that in the opinion of the
investigator would interfere with the trial evaluations or optimal
participation in the trial.
- Any participant with a member or a family member of the personnel
of the investigational or sponsor staff directly involved with this trial.
me Timepoints
1.Up to 42 weeks from the beginning of P06153
6.Screening and 40 weeks from the beginning of
P06153
me Timepoints
Up to 42 weeks from the beginning of P06153

for up to 52 weeks (from the beginning of

erize the efficacy of preladenant over the
Parkinson’s disease (PD).
ouble Dummy Extension Study of
for up to 52 weeks (from the beginning of
erize the efficacy of preladenant over the
Parkinson’s disease (PD).
ouble Dummy Extension Study of
page 6 / 8
PDF of Trial
for approximately 42 weeks in P06153 (ie, 40
t).
years from the beginning to the end of the
t with last subject).
psule. A placebo tablet matching
o will be available.
ceive one tablet and one capsule orally each

double-dummy design
page 7 / 8
PDF of Trial
page 8 / 8
PDF of Trial
n, 08 Jan 2023 04:53:32 GMT)

transplant
rapy in a steriod free maintenance
ing live donor renal transplantation
Identifier
NIL
Dr Vijay Kher
Chairman
Medanta - The Medicity
Division of Nephrology and Renal Transplant Medicine Medanta
Kidney & Urology Institute Sector -38
Gurgaon
HARYANA
122001
India
9811054118
vijay.kher@medanta.org
Dr Vijay Kher
Chairman
Gurgaon
HARYANA
122001
India
9811054118
Dr Vijay Kher
Chairman
Gurgaon
HARYANA
122001
India
9811054118
page 1 / 4
PDF of Trial
dge, MA 02142 USA
Dr Vijay Kher
Chairman - Division of Nephrology & Renal Transplant Medicine
Medanta Kidney & Urology Institute Medanta - The Medicity
Sector-38 Gurgaon - 122001 Haryana
Private hospital/clinic
Address
NIL
edanta - The Medicity Medanta-The Medicity, 0124-4141414

Division of Nephrology vijay.kher@medanta.or
and Renal Transplant g
Medicine, Medanta
Kidney & Urology
Institute Sector 38,
Gurgaon-122001
Gurgaon
HARYANA

Committee?
Date
27/04/2011
27/04/2011
Condition
Induction therapy(Thymoglobuline) on patients
undergoing live donor renal transplantation
Name Details
Thymoglbuline Thymoglobuline will be
adminsitered at 3mg/kg on day
of transplant beginning at least
1hr prior to reperfusion of the
graft and 3mg/kg on day 1 post
transplant
Inclusion Criteria
18.00 Year(s)
80.00 Year(s)
Both
Recipients of first living related donor kidney transplant Aged
more or equal to 18 years Male and Female If female of
child bearing potential: Must not be lactating; Must have a
negative serum B-HCG within 24 hrs prior to Day-0 Must agree
to practice an acceptable and reliable form of contraception during
the study Signed Informed Consent
page 2 / 4
PDF of Trial
Exclusion Criteria
1. Recipients taking prednisone at the time of their transplant
2. Recipients requiring prednisone for an underlying disease
3. Recipients who are undergoing second or more transplants
4. Recipients with Hepatitis B or C infection
5. CMV sero-negative recipients receiving an organ from a CMV
sero-positive donor (CMV D+/R-)
6. Pregnancy
7. Patients with Known contraindication to administration of rabbit
antithymocyte globulin
8. Patients with known allergy to rabbit derived products
9. Participation in another clinical study using another non-licensed
pharmaceutical
10. Inability or missing willingness to participate in the study
11. Any other significant disease or medical conditions that, in the
opinion of the Investigator, may preclude participation in the study
me Timepoints
6 months
me Timepoints
6 months

page 3 / 4
PDF of Trial
This is a prospective, open-label, single arm study that will be conducted at Medanta-The
38, Gurgaon, Haryana. All the patients getting first kidney
transplantation in our living donor programme will be eligible for the study. All patients will
gn an ethics committee approved informed consent in order to participate in the study.
monitored twice a week for the first month post-transplant,
month post-transplant, and then every 2 weeks in month
nsplant, and then once a month from month 4 to 6 post-transplant. During these
study visits, complete blood cell count (CBC) and renal allograft parameters will be done
In addition, at baseline and monthly intervals, liver panels, blood sugar, lipid profile and
urine protein creatinine ratio will be determined. In addition, at 3 months and 6 months
intact PTH will be performed. Additionally, at 6 months,
All recipients will be screened for CMV-PCR for 6 months post-transplant. The frequency
(prior to transplant) and then once a week for the
thereafter once monthly for the remaining 3 months.
dysfunction will undergo biopsy of the graft which

on.
page 4 / 4
PDF of Trial
n, 08 Jan 2023 04:53:37 GMT)
l Registered Retrospectively
evere epilepsy
dvanced neuroimaging inn refractory
Identifier
NIL
Dr Prakash Kori
Senior Resident
chatrapati shahuji maharaj medical university,lucknow
Dr prakash kori senior Resident Dept of Neurology Chatrapati
shahuji maharaj medical university ,lucknow
Lucknow
UTTAR PRADESH
226012
India
07398842297
-
drprakashkori@gmail.com
Dr RKGarg
Prof and HOD department of neurology
Professor and head of department chatrapati shauji maharaj medical
university lucknow
Dr R.K.Garg DM Prof and HoD Dept of Neurology Chatrapati shauji
maharaj medical university,Lucknow
Lucknow
UTTAR PRADESH
226012
India
9335901790
-
garg50@yahoo.com
Dr Prakash Kori
Senior Resident
seniro resident chatrapati shauji maharaj medical university,lucknow
Dr prakash kori senior Resident Dept of Neurology Chatrapati shauji
maharaj medical university,Lucknow
Lucknow
UTTAR PRADESH
226012
India
page 1 / 4
PDF of Trial
07398842297
-
ucknow
nil
not applicable
Other [not applicable]
Address
NIL
atrapathi shahuji Department of 05222258852

aharaj medical neurology chatrapathi -
lege university sahuji maharaj medical garg50@yahoo.com
know university lucknow
Lucknow
UTTAR PRADESH

Committee?
proved 29/01/2011 Yes
Date
No Date Specified
Condition
epilepsy
Name Details
magnetic resonance imaging of The MRI imaging of brain is a
brain along with sequences like neuroimaging based on
DTI ASL magnetic property of brain
tissue which is used routinely
for diagnostic purpose of
various epileptic disorders.Here
we use along with routine MRI
special sequences like DTI ASL
which is a component of MRI
brain imaging is used.These
sequences measures the blood
flow to particular area of
epileptic focus in the
brain.These sequences will be
done by the same MRI machine
which is routinely used for
neuroimaging.
videoelectroencephalogram of videoelectroencephalogram is a
brain externaly used device wherein
electrodes applied over the
external surface of head and
electric discharges of inside
page 2 / 4
PDF of Trial
brain is recorded over a monitor
attached to the electrodes and
hence if any epileptic
discharged are noted they can
be detected and as well as
localised to particular part of
brain
Inclusion Criteria
1.00 Year(s)
80.00 Year(s)
Both
All Patients with epilepsy disorder who satisfy the criteria adopted in
our study proposed by Berg et al i.e, Failure of two or more
antiepileptic drugs and occurrence of one or more seizures per
month over 18 months with no more than 3 months seizures free
will be included in our study.
Exclusion Criteria
Those patients with refractory epilepsy not strictly adhering to
antiepileptic medication Patients who have taken underdosage of
antiepileptic or dosage for inadaquate time .
me Timepoints
after 6 months of enrollment of patients
me Timepoints
nil

olled on two or more antiepileptic drugs

per month in last 18 months are included
nical features and syndromic diagnosis if
nd epileptiform discharges are noted and
undergo advanced Neuroimaging of brain
calisation in the brain. The results will be
sy and is there any significant correlation
olled on two or more antiepileptic drugs
per month in last 18 months are included
nical features and syndromic diagnosis if
nd epileptiform discharges are noted and
undergo advanced Neuroimaging of brain
calisation in the brain. The results will be
sy and is there any significant correlation
page 3 / 4
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d VideoEEG. The patients are also follwed up for 6

page 4 / 4
PDF of Trial
n, 08 Jan 2023 04:53:46 GMT)
henolate modified release tablets in the
TICENTRE STUDY TO ASSESS THE

ABLETS* (PANACEA BIOTEC LTD) IN
ACEUTICALS CORPORATION) IN THE
ANSPLANTATION
Identifier
Protocol Number
Dr Arani Chatterjee
Senior Vice President
Panacea Biotec Ltd, B-1 Ext/G-3, Mohan Cooperative Industrial

Estate, Mathura Road, New Delhi-110044
New Delhi
DELHI
110044
India
011-41679000
011-41578085
aranichatterjee@panaceabiotec.com
Dr Arani Chatterjee

New Delhi
DELHI
110044
India
011-41679000
011-41578085
Dr Arani Chatterjee

New Delhi
DELHI
110044
page 1 / 4
PDF of Trial
India
011-41679000
011-41578085

Panacea Biotec Ltd
B-1 Extn/G-3, Mohan Co-op. Industrial Estate, Mathura Road, New
Delhi-110044
Pharmaceutical industry-Indian
Address
NA
ollo Hospital Apollo Hospital, Sainik 09337103451

School Road, nkmty2002@gmail.com
Bhubaneswar, Orissa
Khordha
ORISSA
edanta- The Medicity Medanta Kidney and 09811054118
Urology Institute, vijay.kher@rediffmail.co
Medanta- The Medicity, m
Second Floor, Sector
38 Gurgaon
Gurgaon
HARYANA
edica Superspeciality Medica Superspeciality 09874679469

spital Hospital, 127 E M dilip.pahari@medicasyn
Bypass, Mukundapur, ergie.in
Kolkata
Kolkata
WEST BENGAL
IICS Hospital RTIICS Hospital, 124, 09831824751

Mukundapur, E M deepak_ray@hotmail.c
Bypass, Kolkata om
Kolkata
WEST BENGAL
Shubham Kidney Diseases and 09824542389

Superspeciality Hospital Transplant Foundation, hiral_6@yahoo.com
Shubham
Superspeciality
Hospital, Naranpura,
Ahmedabad
Ahmadabad
GUJARAT

Committee?
view
page 2 / 4
PDF of Trial
view
Date
05/12/2011
Condition
Patients with renal transplantation
Name Details
Mycophenolate MR Tablets Mycophenolate MR Tablets
(Panacea Biotec Ltd) Dose: 720 mg Duration: 12
weeks Frequency: Two tablets
once daily Route: oral
Myfortic (Novartis Myfortic Tablets Dose: 360 mg
Pharmaceuticals Corporation) Duration: 12 weeks Frequency:
Two tablets twice daily Route:
oral
Inclusion Criteria
18.00 Year(s)
75.00 Year(s)
Both
1. Patients of either sex, 18-75years 2. Patients having at least
40 Kg of body weight 3. Patients receiving their first kidney
transplant 4. Patients willing to give informed consent 5.
Patients able to take oral medications 6. Patients having
negative T-cell cross match 
Exclusion Criteria
1. Pregnant women and lactating women
2. Women who do not agree to use adequate method for
contraception
3. Recipient of paediatric enbloc kidney
4. WBC count of 2,500 cells/mm3, platelet count 1000X 103
cells/mm3 or Hb 6 g%
5. Patients who have receiveda multi-organ transplant
6. Systemic infections requiring continued antibiotic therapy
7. Patients with active liver disease, HBsAg, HCV or HIV positive
patients
8. Patients with known hypersensitivity to mycophenolate or any
components of the formulation, cyclosporine or steroids
9. Malignancy or history of malignancy other than adequately treated
skin carcinoma
10. Patients receiving investigational prophylactic
immunosuppressants
11. Patients with active ulcer disease, severe diarrhoea, or any other
GI disorder that might interfere with the absorption of medications
12. Patients who do not fully understand the purpose of the study or
were already involved in other studies
page 3 / 4
PDF of Trial
me Timepoints
12 weeks of study treatment
me Timepoints
12 weeks of study treatment

ice daily in renal transplant

novel modified release formulation
m which is to be taken once daily
armacokinetic studies conducted
ed release formulation of
the 24 hours including the trough
valuate the non inferiority of novel
MR (Panacea Biotec Ltd) given
maceuticals Corporation)
ice daily in renal transplant
novel modified release formulation
m which is to be taken once daily
armacokinetic studies conducted
ed release formulation of
the 24 hours including the trough
valuate the non inferiority of novel
MR (Panacea Biotec Ltd) given
maceuticals Corporation)
page 4 / 4
PDF of Trial
n, 08 Jan 2023 04:53:51 GMT)
rain imaging and its long term effects
Identifier
NIL
ARVIND GUPTA
SENIOR RESIDENT
DEPARTMENT OF NEUROLOGY, CHHATRAPATI SHAHUJI
MAHARAJ MEDICAL UNIVERSITY , LUCKNOW, UP
MAHARAJ MEDICAL UNIVERSITY , LUCKNOW, UP 801,
ROSEMERRY BLOCK, ELDECO PARKVIEW APARTMENTS
SITAPUR ROAD,lucknow Lucknow UTTAR PRADESH 226003 India
Lucknow
UTTAR PRADESH
226003
India
07499438644
drarvindagupt@yahoo.co.in
DR M K SINGH
PROFESSOR
Lucknow
UTTAR PRADESH
226003
India
09839038491
maneesh_singh@rediffmail.com
ARVIND GUPTA
SENIOR RESIDENT
MAHARAJ MEDICAL UNIVERSITY , LUCKNOW, UP 801,
ROSEMERRY BLOCK, ELDECO PARKVIEW APARTMENTS
page 1 / 3
PDF of Trial
SITAPUR ROAD,lucknow Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India
07499438644
drarvindagupt@yahoo.co.in
ERSITY , LUCKNOW, UP
CHHATRAPATI SHAHUJI MAHARAJ MEDICAL UNIVERSITY
CHHATRAPATI SHAHUJI MAHARAJ MEDICAL UNIVERSITY ,
LUCKNOW, UP
Government medical college
Address
NIL
EPARTMENT OF DEPARTMENT OF 07499438644

EUROLOGY, NEUROLOGY, drarvindagupt@yahoo.c
HHATRAPATI CHHATRAPATI o.in
HAHUJI MAHARAJ SHAHUJI MAHARAJ
EDICAL MEDICAL
NIVERSITY , UNIVERSITY ,
CKNOW, UP LUCKNOW, UP
Lucknow
UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
DISEASES REELATED TO THALAMIC
LESIONS ON BRAIN IMAGING
Name Details
Inclusion Criteria
1.00 Year(s)
90.00 Year(s)
Both
Patients found to have thalamic lesions on CT or MRI are included in
study
Exclusion Criteria
NONE
page 2 / 3
PDF of Trial
me Timepoints
ed after 6 months of 3 AND 6 MONTHS
ed Barthel index scores
me Timepoints
3 AND 6 MONTHS

Y THE CLINICAL AND RADIOLOGICAL

NS ON BRAIN IMAGING , DONE IN
S OF DEPARTMENT OF NEUROLOGY,
ESED AT 3 AND 6 MONTHS
page 3 / 3
PDF of Trial
n, 08 Jan 2023 04:53:56 GMT)
es in neuroimaging
Identifier
NIL
Dr prakash kori
senior resident
senior resident
chatrapati shauji maharaj medical university lucknow
senior resident Department of neurology chatrapati shauji maharaj
medical university lucknow
Lucknow
UTTAR PRADESH
226003
India
7398842297
-
Dr R K Garg
Professor and head of department
Professor and head of department Department of neurology
Lucknow
UTTAR PRADESH
226003
India
9335901790
-
garg50@yahoo.com
Dr R K Garg
Professor and head of department
Professor and head of department Department of neurology
Lucknow
UTTAR PRADESH
226003
India
9335901790
page 1 / 3
PDF of Trial
-
garg50@yahoo.com
ucknow
nil
Not applicable
Other [Not applicable]
Address
not applicable
partment of Department of 05222258852

urology chatrapathi neurology chatrapathi garg50@yahoo.com
ahuji maharaj sahuji maharaj medical
edical college university lucknow
versity lucknow Lucknow
Lucknow
UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
condition would be primarily disease or may be
condition for which patient is admitted where in
white matter changes are seen secondarily all
these patients
Name Details
Routine standard management Management as per cause
identified
Inclusion Criteria
1.00 Year(s)
80.00 Year(s)
Both
Those patients having multifiocal /diffuse white matter changes in
neuroimaging will be included in our study
Exclusion Criteria
patients having ischemic periventricular white matter changes
associated with hypertension on neuroimaging
page 2 / 3
PDF of Trial
me Timepoints
These would be applied after 6 weeks and 6
months of treatment
me Timepoints
nil

ment ward and these patients when they

ging as a part of diagnosis for the
patients will be assessed in detail clinically
le out infectious cause and immuological
d examination and infectious markers
d IgG and Igm anti measles antibodies will
agnosis. These patients will be followed up
assessed .
page 3 / 3
PDF of Trial
n, 08 Jan 2023 04:54:12 GMT)
CXA-201 and Intravenous Levofloxacin in

ritis
to Compare the Safety and Efficacy of
omplicated Urinary Tract Infection,
Identifier
Protocol Number
ClinicalTrials.gov
Mr Lokesh Chaudhari
trial coordinator for Indian Sites
Manager, Clinical Operations, PRA India.
PRA Health Sciences A 602 A 603 CTS No 1498 A/2 M.V. Road,
Marol • Andheri East
Mumbai
MAHARASHTRA
400 059
India
91-22-71234116
91-22-71234198
pandotratarun@praintl.com
Mr Lokesh Chaudhari
Manager, of Clinical Operations, PRA India.
PRA International M.V. Road, Marol • Andheri (East) • Mumbai
Mumbai
MAHARASHTRA
400 059
India
91-22-71234116
91-22-71234198
chaudharilokesh@prahs.com
Mr Lokesh Chaudhari
Manager, Clinical Operations, PRAHealth Sciences
The Qube • A-602 & A-603 • C.T.S.No.1498 A/2 M.V. Road, Marol •
Andheri (East) • Mumbai – 400 059
Mumbai
MAHARASHTRA
400 059
page 1 / 7
PDF of Trial
India
91-22-71234116
91-22-71234198
chaudharilokesh@prahs.com
on, MA 02421
Cubist Pharmaceuticals Inc
65 Hayden Avenue Lexington, MA 02421
Address
PRA International ;402, B Wing, Business
Square, Andheri-Kurla Road, Chakala, Andheri
(E) .Mumbai - 400 093.INDIA
ollo Hospitals Dept of 91-9849420202

Nephrology,Apollo 91-40-23543270
Health City,Jubilee hyd@aherf-smo.org
Hills,Hyderabad- 500
096
Hyderabad
ANDHRA PRADESH
hatrapati Shahuji Department of Urology, 91-9839181465

aharaj Medical Chowk, 91-522-2256543
iversity Lucknow-226003. goelapul1@rediffmail.c
Lucknow om
UTTAR PRADESH
yanand Medical Dept of Medicine, 2nd 91-9815532533

llege & Hospital Floor, New Tagore 91-161-2303263
Nagar, Civil Lines, drjaindinesh@yahoo.co
Ludhiana - 141 001 .in
Ludhiana
PUNJAB
cel Hospital 8-15, 3rd Floor, Sheetal 91-9825276278

Shopping Square, (Old 91-261-2236037
LB Cinema), Ghod dod kapilthakkar@gmail.co
– Bhatar Road m
Junction, Surat -395
001.
Surat
GUJARAT
rtis Hospital - Mohali Dept of Urology,Phase 91-9915597457

VIII, Sector 62,Mohali - manishahuja75@hotma
160 062 il.com
Ludhiana
page 2 / 7
PDF of Trial
PUNJAB
jarat Kidney 4-5th Floor, Shaival 91-9825008924
undation complex, Near Suvidha 91-79-26652224
Shopping centre, sonalsanjeev@yahoo.c
Between Parimal om
crossing & Mahalaxmi
Char Rasta,
Paldi,Ahmedabad.
Ahmadabad
GUJARAT
titute of Kidney B.J Medical College & 91-79-22685600

seases & Research Civil Hospital Campus, 91-79-22682811
ntre Asarwa, Ahmedabad - drhtrivedi@yahoo.com
380016.
Ahmadabad
GUJARAT
sturba Medical Dept of Urology, Post 91-9008002440

llege & Hospital Box No 7, Manipal - 91-820-2571834
576104. urologyarun@yahoo.co
Bangalore Rural m
KARNATAKA
ravan Hospital and 239, Nandanwan 91-9823071748

dney Institute Cement road, Near 91-712-2441347
Shikshak Sahakari prakashkhe@gmail.co
Bank, Nagpur-440009 m
Nagpur
MAHARASHTRA
ree Giriraj 150 Feet Ring 91-9909971118

ultispeciality Hospital Road,27-Navjyot Park 91-281-2226706
Main Road,Amin Marg drmayankthakker@gma
Cross il.com
Road,Rajkot-360005
Rajkot
GUJARAT
ddhivinayak Hospital Balvatika-Maninagar Ro 91-9426533707

ad,Maninagar,Ahmedab 91-79-25471427
ad-380008. drvipulshah@rediffmail.
Ahmadabad com
GUJARAT
Johns Medical Department of 91-9845105068
llege Hospital Nephrology, Sarjapur 91-80-25633844
Road, Bangalore - 560 gokul_neph@yahoo.co.
034. uk
Bangalore
KARNATAKA

Committee?
page 3 / 7
PDF of Trial

Date
Date
26/07/2012
Condition
Complicated Urinary Tract Infection, Including
Pyelonephritis
Name Details
CXA-201 CXA-201 IV infusion (1500mg)
Dosing Frequency: every
8hours for 7 days.
Levofloxacin Levofloxacin IV infusion
(750mg). Dosing Frequency: 4
times in a day for 7 days.
Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
1.Provide written informed consent prior to any study-related
procedure not part of normal medical care (a legally acceptable
representative may provide consent if the subject is unable to do so,
provided this is approved by local country and institution specific
guidelines). 2.Be males or females more than or equal to 18
years of age 3.If female, subject is non-lactating, and is
either: a.Not of childbearing potential, defined as
postmenopausal for at least 1 year or surgically sterile due to
bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or
 b.Of childbearing potential and is practicing a barrier method of
birth control (e.g., a diaphragm or contraceptive sponge) along with 1
of the following methods: oral or parenteral contraceptives (for 3
months prior to study drug administration), or a vasectomized
partner. Or, subject is practicing abstinence from sexual intercourse.
Subjects must be willing to practice these methods for the duration of
the trial and for at least 35 days after last dose of study medication.
 4.Males are required to practice reliable birth control methods
page 4 / 7
PDF of Trial
(condom or other barrier device) during the conduct of the study and
for at least 35 days after last dose of study medication. 
5.Pyuria (white blood cell [WBC] count more than 10/ in unspun
urine or more than or equal to 10 per high power field in spun urine).
 6.Clinical signs and/or symptoms of cUTI, either of: 
a.Pyelonephritis, as indicated by at least 2 of the following: 
 1.Documented fever (oral temperature more than 38C)
accompanied by patient symptoms of rigors, chills, or "warmth";
 2.Flank pain; 3.Costovertebral angle tenderness or
suprapubic tenderness on physical exam; or 4.nausea or
vomiting; OR b.Complicated lower UTI, as indicated by at least
2 of the following: At least 2 of the following new or
worsening symptoms of cUTI: 1.Dysuria; urinary
frequency or urinary urgency; 2.Documented fever (oral
temperature more than 38C) accompanied by patient symptoms of
rigors, chills, or "warmth"; 3.Suprapubic pain or flank pain;
 4.Costovertebral angle tenderness or suprapubic tenderness
on physical exam; or 5.Nausea or vomiting; plus, 
At least 1 of the following complicating factors: 1.Males
with documented history of urinary retention; 2.Indwelling
urinary catheter that is scheduled to be removed during IV study
therapy and before the EOT; 3.Current obstructive uropathy
that is scheduled to be medically or surgically relieved during IV
study therapy and before the EOT; or 4.Any functional or
anatomical abnormality of the urogenital tract (including anatomic
malformations or neurogenic bladder) with voiding disturbance
resulting in at least 100 mL residual urine. 7.Have a
pretreatment baseline urine culture specimen obtained within 24
hours before the start of administration of the first dose of study
drug. NOTE: Subjects may be enrolled in this study and
start IV study drug therapy before the Investigator knows the results
of the baseline urine culture. 8.Require IV antibacterial
therapy for the treatment of the presumed cUTI. 
Exclusion Criteria
1.Have a documented history of any moderate or severe
hypersensitivity or allergic reaction to any lactam or quinilone
antibacterial (Note: for lactams, a history of a mild rash followed by
uneventful re-exposure is not a contraindication to enrollment)
2.Have a concomitant infection at the time of randomization, which
requires non-study systemic antibacterial therapy in addition to IV
study drug therapy. (Drugs with only gram-positive activity [e.g.,
vancomycin, linezolid] are allowed.)
3.Receipt of any amount of potentially therapeutic antibacterial
therapy after collection of the pretreatment baseline urine culture and
before administration of the first dose of study drug.
4.Receipt of any dose of a potentially therapeutic antibacterial agent
for the treatment of the current UTI within 48 hours before the
study-qualifying pretreatment baseline urine is obtained (exceptions:
subjects with an active cUTI who have received prior antibiotics may
be enrolled provided a minimum of 48 hours have elapsed between
the last dose of the prior antibiotic and the time of obtaining the
baseline urine specimen. Subjects receiving current antibiotic
prophylaxis for cUTI who present with signs and symptoms
consistent with an active new cUTI may be enrolled provided all
other eligibility criteria are met including obtaining a pre-treatment
qualifying baseline urine culture).
5.Intractable urinary infection at baseline that the Investigator
anticipates would require more than 7 days of study drug therapy.
6.Complete, permanent obstruction of the urinary tract.
7.Confirmed fungal urinary tract infection at time of randomization
page 5 / 7
PDF of Trial
(with more than or equal to 103 fungal CFU/mL).
8.Permanent indwelling bladder catheter or urinary stent including
nephrostomy.
9.Suspected or confirmed perinephric or intrarenal abscess.
10.Suspected or confirmed prostatitis.
11.Ileal loop or known vesico-ureteral reflux.
12.Severe impairment of renal function including an estimated CrCl
less than 30 mL/min, requirement for peritoneal dialysis,
hemodialysis or hemofiltration, or oliguria (less than 20 mL/h urine
output over 24 hours).
13.Current urinary catheter that is not scheduled to be removed
before the EOT (intermittent straight catheterization during the IV
study drug administration period is acceptable).
14.Any condition or circumstance that, in the opinion of the
Investigator, would compromise the safety of the subject or the
quality of study data.
15.Any rapidly progressing disease or immediately life-threatening
illness including acute hepatic failure, respiratory failure, and septic
shock.
16.Immunocompromising condition, including established AIDS,
hematological malignancy, or bone marrow transplantation, or
immunosuppressive therapy including cancer chemotherapy,
medications for prevention of organ transplantation rejection, or the
administration of corticosteroids equivalent to or greater than 40 mg
of prednisone per day administered continuously for more than 14
days preceding randomization.
17.One or more of the following laboratory abnormalities in baseline
specimens: aspartate aminotransferase (AST [SGOT]), alanine
aminotransferase (ALT [SGPT]), alkaline phosphatase, or total
bilirubin level greater than 3 times the upper limit of normal (ULN),
absolute neutrophil count less than 500/, platelet count less than
40,000/, or hematocrit less than 20%.
18.Participation in any clinical study of an investigational product
within 30 days prior to the proposed first day of study drug.
19.Previous participation in any study of CXA-101 or CXA-201.
20.Women who are pregnant or nursing.
me Timepoints
Test of Cure Visit (7 Days [± 2 days] after
completion of study drug administration
me Timepoints
Multiple visits up until the Late Follow Up (28-35
Days after completion of study drug
administration
Multiple visits up until the Late Follow Up (28-35
administration
All study visits through the Late Follow Up (28-35
administration
Late Follow Up (28-35 Days after completion of
page 6 / 7
PDF of Trial
study drug administration)
y and randomized 1:1 to receive CXA-201

treatment arm. Subject participation will
um of 42 days. Subjects will be hospitalized
est of cure visit will occur at 7 days after
n or contact will occur a minimum of 28
dy drug.
-201
infusion (1500mg q8) for 7 days
acin
ys
y and randomized 1:1 to receive CXA-201
treatment arm. Subject participation will
um of 42 days. Subjects will be hospitalized
est of cure visit will occur at 7 days after
n or contact will occur a minimum of 28
dy drug.
-201
infusion (1500mg q8) for 7 days
acin
ys
page 7 / 7
PDF of Trial
n, 08 Jan 2023 04:54:54 GMT)
Resistant Prostate Cancer
d Study of Tasquinimod in Men with
Identifier
Protocol Number
ClinicalTrials.gov

Arun Sundriyal
Associate Director
PPD Pharmaceutical Development India Pvt. Ltd.
Vatika City Point,11th Floor,Sector 25,Mehrauli Gurgaon Road,
Gurgaon–122002,India
Gurgaon
HARYANA
122002
India
91-124-4739903
91-124-4739999
Arun.Sundriyal@ppdi.com
Arun Sundriyal
Associate Director - Clinical Management
PPD Pharmaceutical Development India Pvt Ltd.,
PPD Pharmaceutical Development India Pvt Ltd., Vatika City Point,
11th Floor,Sector 25, Mehrauli Gurgaon Road,Gurgaon – 122002
India
Gurgaon
HARYANA
122002
India
page 1 / 7
PDF of Trial
91-124-4739903
91-124-4739903
07 Lund, Sweden
Active Biotech
Active Biotech AB Box 724, Scheelevagen 22 SE-220 07 Lund,
Sweden
Address
01-Dynasty B-Wing (Kanakia Spaces)
Andheri-Kurla Road, Andheri East, Mumbai
MAHARASHTRA 400059 India
page 2 / 7
PDF of Trial
mrita Institute of Amrita Institute of 91-484-4001320

edical Sciences Medical Sciences, 91-484-2854348
Health Care, Education drginil@aims.amrita.ed
& Research, AIMS u
Ponekkara P.O, Cochin
- 682041, Kerala, India
Ernakulam
KERALA
ristian Medical Christian Medical 91-9814034185

llege & Hospital College & Hospital, 91-161-2609958
Department of Urology, kjmammen@gmail.com
Brown Road, Ludhiana
-141008, Punjab, India.
Ludhiana
PUNJAB
hangir Clinical Jehangir Clinical 91-20-26059318
velopment Centre Development Centre 91-20-26059319
t Ltd Pvt Ltd, Jehangir kashyapi1@gmail.com
Hospital Premises, 32
Sassoon Road,
Pune-411001,
Maharashtra, India.
Pune
MAHARASHTRA
onilek Hospital and Monilek Hospital and 91-141-2623535

search Centre Research Centre, 91-141-2652181
Sector-4, Jawahar sltolani@gmail.com
Nagar, Jaipur - 302004,
Rajasthan, India.
Jaipur
RAJASTHAN
chid Nursing Home Orchid Nursing Home, 91-33-65441605

P-17, C.I.T. Road 91-33-40045171
Scheme, VI M, docgs@hotmail.com
Phoolbagan, Kolkata -
700054, West Bengal,
India.
Kolkata
WEST BENGAL
Shatabdi Shatabdi 91-253-2501888

Superspeciality Hospital Superspeciality 91-253-2502105
Hospital, Suyojit City shaileshbondarde@yah
Centre, Opp. oo.com
Mahamarg Bus Stand,
Mumbai Naka, Nashik –
422005, Maharashtra
India.
Nashik
MAHARASHTRA
page 3 / 7
PDF of Trial
ta Memorial Hospital Tata Memorial Hospital, 91-22-24177214

Dr. Ernest Borges 91-22-24177214
Marg, Parel, vanita.noronha@gmail.
Mumbai-400012, com
Maharashtra, India.
Mumbai
MAHARASHTRA

Committee?
Date
12/07/2012
Condition
Metastatic Castrate Resistant Prostate Cancer
Name Details
Drug: tasquinimod 0.25 mg/day of tasquinimod for
at least 2 weeks. Once
tolerability of the 0.25 mg/day
dose is established, patients will
receive a dose increase to 0.5
mg/day for at least 2 weeks,
and then increase up to a
maximum maintenance dose of
1 mg once daily, administrated
orally capsule. The study
treatment can continue beyond
radiological disease
progression, if it is felt that the
patient is benefiting clinically
from the treatment (aprx 2
years)
Experimental: Placebo Administrated orally (capsule)
page 4 / 7
PDF of Trial
Inclusion Criteria
18.00 Year(s)
80.00 Year(s)
Male
1. Age at least 18 years and less than or equal 80 years at the time
of signing the informed consent form. 2. Asymptomatic or
mildly symptomatic (as per decision of investigator) histologically
confirmed adenocarcinoma of the prostate. 3.
Histologically confirmed diagnosis of adenocarcinoma of the
prostate. 4. Evidence of bone metastatic disease on
radiographic examination, whether from bone scan (bone lesions) or
other imaging modality. 5. Castrate levels of serum
testosterone (less than or equal 50 ng/dL or 1.7 nmol/L). 
6. Evidence of progressive disease after castration levels of
testosterone have been achieved. 7. Karnofsky score
more than or equal 70%. 8. Meet screening laboratory
values as specified in thr protocol. 9. If sexually active
with partner of childbearing potential, patient will agree to use
adequate contraceptive methods (barrier contraceptive with
spermicide or vasectomy) while on study drug. The adequate
contraceptive method should be continued for 14 days after the
patient stops taking study drug. 10. No evidence (within 5
years) of prior malignancies (except successfully treated basal cell or
squamous cell carcinoma of the skin). 11. Able to
swallow and retain oral medication. 12. Able to adhere to
the study visit schedule and other protocol requirements. 
13. Ability to comprehend the full nature and purpose of the study,
including possible risks and side effects; ability to cooperate with the
investigator and to comply with the requirements of the entire study.
 14. Able (or patients legal guardian, if applicable) to sign
and date the written informed consent after being informed of the full
nature and purpose of the study, including possible risks and side
effects, and given ample time and opportunity to read and
understand this information.
Exclusion Criteria
1. Prior cytotoxic chemotherapy for the treatment of prostate cancer
within 2 years or within 4 weeks for Estracyt (estramustine) prior to
study treatment.
2. Previous anticancer therapy using radiation, biologics or vaccines,
including abiraterone, TAK-700(Orteronel), or MDV3100 within 4
weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the
start of study treatment. If radiation therapy is applied after baseline
scan, a new baseline scan needs to be done at least 4 weeks after
the radiation therapy.
3. Previous therapy with antiandrogens within 4 weeks (within 6
weeks for bicalutamide eg, Casodex)prior to study treatment.
4. Concurrent use of other anticancer agents or treatments, with the
following exceptions:
- Ongoing treatment with luteinizing hormone-releasing hormone
agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg,
zoledronic acid) is allowed. Ongoing treatment should be kept at a
stable schedule; however, if medically required, a change of dose,
compound, or both is allowed.
5. Any treatment modalities involving major surgery within 4 weeks
prior to the start of study treatment.
6. Prostate cancer pain that requires ongoing treatment with narcotic
analgesics or warrants the initiation of radio- or chemotherapy.
page 5 / 7
PDF of Trial
7. Ongoing treatment with warfarin. Treatment with other
anticoagulants is allowed but should be discussed with medical
monitor before inclusion.
8. Maintenance treatment with corticosteroids corresponding to a
prednisolone or prednisone dose above 10 mg/day. The dose must
have been stable for at least 5 days.
9. Systemic exposure to ketoconazole or other strong cytochrome
P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior
to the start of study treatment. Systemic exposure to amiodarone is
not allowed within 1 year prior to the start of study treatment.
10. Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2
substrate with narrow therapeutic range at the start of study
treatment.
11. Ongoing treatment with CYP3A4 substrate with narrow
therapeutic range at the start of study treatment.
12. Simultaneous participation in any other study involving treatment
with investigational drugs or having received treatment with
investigational drugs less than 4 weeks prior to the start of study
treatment.
13. Myocardial infarction, percutaneous coronary intervention, acute
coronary syndrome, coronary artery bypass graft, class III/IV
congestive heart failure, cerebrovascular accident, transient ischemic
attack, or limb claudication at rest, within 6 months prior to start of
study treatment and ongoing symptomatic dysrhythmias, unstable
angina, uncontrolled hypertension, and uncontrolled atrial or
ventricular arrhythmias.
14. History of pancreatitis.
15. Known brain or epidural metastases.
16. Known positive serology for HIV (patients with known history of
HIV will be excluded because of potential for unforeseen toxicity and
morbidity in an immunocompromised host).
17. Chronic hepatitis with advanced, decompensated hepatic
disease or cirrhosis of the liver or history of a chronic viral hepatitis
or known viral hepatitis carrier (patients who have recovered from
hepatitis will be allowed to enter the study).
18. Patients with active tuberculosis (TB), or with known, untreated
latent TB. (Country-specific TB therapy should have been given for
at least 30 days prior to the start of study treatment and the patient
should intend to complete the entire course of that therapy.)
19. Any condition, including other active or latent infections, medical
or psychiatric conditions, or the presence of laboratory abnormalities,
which could confound the ability to interpret data from the study or
places the patient at unacceptable risk if he participates in the study.
20. Any patient who in the opinion of the investigator should not
participate in the study
page 6 / 7
PDF of Trial
me Timepoints
5 years
me Timepoints
NA

rolled study of tasquinimod in

atic CRPC to confirm the effect of
with placebo.
page 7 / 7
PDF of Trial
n, 08 Jan 2023 04:55:17 GMT)

page 1 / 1
PDF of Trial
n, 08 Jan 2023 04:55:35 GMT)
ety and pharmacokinetics of a new

s with locally advanced and metastatic
rapeutic equivalence, safety and

75 mg/month) of leuprolide acetate
ocally advanced and metastatic prostate
Identifier
Protocol Number
Dr Mudgal Kothekar MD
Associate Vice President Clinical Development
Sun Pharma Advanced Research Company Ltd
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.
Mumbai
MAHARASHTRA
400093
India
912266455645
Clinical.Trials@sparcmail.com
Associate Vice President - Clinical Research
Mumbai
MAHARASHTRA
400093
India
912266455645
Associate Vice President Clinical Development
Mumbai
MAHARASHTRA
400093
India
page 1 / 8
PDF of Trial
912266455645

Sun Pharma Industries Limited
Acme Plaza, Andheri - Kurla Rd, Andheri (E), Mumbai - 400 059
Address
NIL
MAI Chharitable S.R No 32 2 A . 9881256992

usts ACE Hospital Erandwana, Behind suresh_iou@yahoo.co
Mahendar Garage, m
Opp. Hotel Abhishek,
Pune 411004,
Maharashtra
Pune
MAHARASHTRA
opda Medicare & Magnmum Heart 9850829330
search Centre Pvt. Institute, Patil Lane No. drsharadprasad@hotm
d. 1, Canada Corner, ail.com
Nasik- 422005
Maharashtra
Nashik
MAHARASHTRA
pt. of Urology, Tata Memorial Hospital, 9869331584

Room No:51, Ground gkbakshi1973@gmail.c
floor, Dr. E Borges om
Road, Parel, Mumbai -
400 012 Maharashtra,
India
Mumbai
MAHARASHTRA
Ram Manohar Lohia Department of Urology 911123361228

spital and PGIMER, Room No. 31, OPD drsoodr@yahoo.com
w Delhi Block, New Delhi - 110
001
New Delhi
DELHI
cel Hospital 8-15, 3rd Floor, Sheetal 9825276278

Shopping Square (Old kapilthakkar@gmail.co
LB CInema), Ghod m
dod-Bhattar Road
Junction, Surat 395
001, Gujarat
Surat
GUJARAT
CG Bangalore No 8, HCG Towers, P. 9731209671

titute Of Oncology Kalinga Rao Road,
page 2 / 8
PDF of Trial
mpangi Rama drraghunathsk@yahoo.

gar, Bangalore- com
0027
ngalore
RNATAKA
spital Building S. No, 9822059799
, Fatima Nagar, Pune rajendrakshimpi@gmail
11 040, Maharashtra, .com
dia
ne
AHARASHTRA
pt of Urology, Post 9008002440
x 7, Madhava Nagar, urologyarun@yahoo.co
anipal - 576104. m
upi
RNATAKA
partment of Urology 912224071327

Babasaheb drjayeshdhabalia@redif
mbedkar Road, Sion fmail.com
est), Mumbai -
0022, Maharashtra
umbai
AHARASHTRA
SRIT Post, New BEL 9341223663

ad, Bangalore - arunacr1@gmail.com
0054, Karnatka
DIA
ngalore
RNATAKA
1/1,New D P 9822191175
ad,Aundh,Pune-411 ashishpardeshi.pentago
7 n@gmail.com
ne
AHARASHTRA
3, Magarpatta City 9822059799

ad Hadapsar Pune rajendrakshimpi@gmail
1013 .com
ne
AHARASHTRA

. 44/54, 30th Cross, dilipdhanpal@yahoo.co.
aknagar, Jayanagar in
tension, Bangalore –
0041 Karnataka
ngalore
RNATAKA
ar Stadium Circle, 9824047750

varangpura -380009 drjanakddesai@gmail.c
medabad Gujarat om
madabad
UJARAT

ebareli Road, anilpall@yahoo.com
cknow - 226014,
ar Pradesh
cknow
TAR PRADESH
Road,Vidhyanagar, 9844055273
page 3 / 8
PDF of Trial
spital & Research Hubli-580021, drmeherwade.pentagon

ntre Pvt.Ltd Karnataka @gmail.com
Dharwad
KARNATAKA
piwala National Department of Urology, 9820364294
edical College & BYL Dr A L Nair Road, nairurology@yahoo.co.i
ir Hospital Mumbai Central, n
Mumbai-400008.
Maharashtra
Mumbai
MAHARASHTRA
o Health Research 2/503, Vikas Nagar, 9335242329

nter Kursi Road, Lucknow – drdalela@sify.com
226022, Uttar Pradesh
Lucknow
UTTAR PRADESH
M Medical College & Department of Urology 911126190954

fdarjang Hospital, 3rd floor Blood Bank nayankm@yahoo.co.in
w Delhi Building, Sri Aurobindo
Marg,-110029, New
Delhi
New Delhi
DELHI

Committee?

view

view

view
bmittted/Under No Date Specified Yes
view

view
page 4 / 8
PDF of Trial

view

view

view

view

view

view
Date
29/06/2012
Condition
locally advanced and metastatic prostate cancer.
Malignant neoplasm of prostate
Name Details
leuprolide acetate, Leuprolide The study will consist of a
Sun 3.75 mg (Sun 2-month active treatment period
Pharmaceutical Industries (2 cycles). Eligible subjects will
Limited, India). receive 2 doses of either test or
reference at 28-day intervals
starting with the first injection at
baseline
Leuprolide acetate (Lucrin® The study will consist of a

3.75 mg (Abbott S.A)). 2-month active treatment period
(2 cycles). Eligible subjects will
receive 2 doses of either test or
reference at 28-day intervals
page 5 / 8
PDF of Trial
starting with the first injection at

baseline
Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Male
1.Histologic or cytologic diagnosis of adenocarcinoma of the prostate
(stage T1-4 N0-3M0-1). 2.Age ? 18 years. 3.Serum
testosterone levels within normal limits (250-1500 ng/dl) at
screening. 4.ECOG performance status of 0-2. 
5.Estimated life expectancy of at least 8 weeks. 6.Adequate
organ and immune system function as indicated by the following
laboratory values, obtained ? 2 weeks prior to dosing:Serum
creatinine<2.0 mg/dL,Total bilirubin<1.5 mg/dL, AST<5.0 X
ULN, ALT<5.0 X ULN,ANC> 1 X 109 /L,Platelet count> 100 X
109/L,Hemoglobin > 10 g/dL 7.HIV non-reactive. 
8.Accepts post-therapeutic visits at study site. 9.Willing to use
appropriate birth control methods such as surgical sterilization or
barrier contraception, men with partners of child bearing potential
willing to use appropriate birth control methods, such as surgical
sterilization, hormonal birth control (partner), an intrauterine device
(partner) or double-barrier method for the entire study period. 
Exclusion Criteria
1.Subjects who had-
a)An orchiectomy, hypophysectomy, or adrenalectomy.
b)Undergone any prostatic surgery (e.g. transurethral resection of
the prostate (TURP), radical prostatectomy) within 2 weeks of
screening visit.
2.Subjects who had been treated with/used –
a)Prostate cancer therapies (e.g. radiotherapy, brachytherapy,
chemotherapy, immunotherapy, tumor vaccines, biological response
modifiers) within 2 months of screening visit.
b) Luteinizing hormone-releasing hormone (LHRH) agonists (e.g.,
Leuprolide, Goserelin, Buserelin) or antagonists (e.g., degarelix)
within 12 months of screening visit, and/or exceeding 6 consecutive
months at a time.
c)Androgen receptor blockers (e.g., Bicalutamide, Flutamide,
Megestrol acetate, Cyproterone) within 3 months prior to screening
visit.
d)5-alpha-reductase inhibitors (e.g., finasteride, dutasteride) within 3
months prior to screening visit.
e)Investigational drug or device within 3 months of screening.
3.Subjects with anticipated–
a)Need of concomitant medication (anti-androgens) to prevent or
treat flare up reactions such as urinary tract obstruction or spinal
cord compression.
b)Problems for compliance with the planned follow-up visits for this
protocol, in the opinion of the investigator.
4.Subjects with –
a)Evidence of brain metastases, in the opinion of the investigator,
taking into account medical history, clinical observations, and
symptoms.
b)Clinically significant cardiovascular abnormalities. Serious
cardiovascular disorders or procedures (e.g. myocardial infarction,
coronary vascular procedure, uncontrolled congestive heart failure)
within 6 months of study entry.
c)Any symptoms or diseases, which could interfere with the
evaluation of local tolerance of the study medication at the injection
site (e.g. immunization, flu vaccination, etc).
page 6 / 8
PDF of Trial
d)Systemic diseases or other conditions (e.g. hematological, renal,

hepatic, respiratory, endocrine, psychiatric), which would not allow
safe completion of this study protocol in the opinion of the
investigator.
e)Prior or concurrent malignancy (curatively treated
carcinoma-in-situ or basal cell carcinoma or subjects with previously
treated malignancies who have been disease-free for at least 5 years
are eligible).
f)Active hepatitis, HIV (anamnestic evaluation).
g)Active bacterial and viral infection.
h)Active peptic ulcer or active gastrointestinal bleeding.
i)Known hypersensitivity to LHRH, LHRH agonists or any excipients
of the study medication (Test, Reference).
j)History of substance abuse.
5.Subjects who have not recovered from reversible side effects of
previous surgery, chemotherapy or radiation therapy.
me Timepoints
Day 29
me Timepoints
Day 29
Day 29
Day 29

ctive-controlled, parallel groups study
macokinetics of a new monthly depot
Leuprolide Sun 3.75 mg) versus
static prostate cancer. The primary
page 7 / 8
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oncentration within the castration

eek 5).
page 8 / 8
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n, 08 Jan 2023 04:55:56 GMT)
on isomaltoside with mean molecular

1000 mg doses to Inflammatory Bowel
1000 (Monofer®) administered by 500 mg

ects with Inflammatory Bowel Disease
Identifier
Protocol Number

Dr Sumbul Siddiqui
Medical Monitor
Max Neeman International
Max Neeman International Max House, 1, Dr. Jha Marg, Okhla
Phase-III City: New Delhi State: New Delhi Postal Code: 110020
Country: India
South
DELHI
110020
India
91-81-30666357
91-11-41001945
ssiddiqui@neemanasia.com
Dr Shariq Anwar
Director Operations
Max Neeman International
Max Neeman International Max House, 1, Dr. Jha Marg, Okhla
Phase-III City: New Delhi State: New Delhi Postal Code: 110020
Country: India
South
DELHI
110020
India
page 1 / 6
PDF of Trial
91-9810979215
91-11-40548168
sanwar@neemanasia.com

Pharmacosmos AS
Roervangsvej 30, DK-4300 Holbaek,Denmark.USA
Address
Max House,1st Floor 1 Dr. Jha Marg, Okhla III
New Delhi- 110020
pital Urology and Capital Urology and 91-9928383737

stro Hospital Gastro Hospital, 0141-2213070
Department of abhinavsharma.net@g
Gastroenterology A Unit mail.com
of City Hospital, S-35-B,
Radha Marg, Behind
Raj Mandir Cinema, C
scheme, India
Jaipur
RAJASTHAN
t Endoscopy Clinic Gut Endoscopy Clinic, 91-7354791313
Plot No: 07, New 0755-6446555
Friends Colony, Chuna gifna97@rediffmail.com
Bhatti, Pin Code
-462016 India
Bhopal
MADHYA PRADESH
ehta Hospital Mehta Hospital, 57, 91-9824022882

Brahmin Mitra Mandal 91-079-26585741
Society, B/W Paldi Bus drrupeshmehta@gmail.
Stop & Jalaram Mandir, com
Paldi, Pin Code -
380006, India
Ahmadabad
GUJARAT
das MultiSpeciality Midas MultiSpeciality 91-9823054474

spital Hospital Pvt. Ltd, Midas 91-0712-2442536
height, 07- Central shrikant_mukewar@ya
Bazar Road, hoo.com
Ramdaspeth, Pin Code
– 440010,India
Nagpur
MAHARASHTRA
garjuna Hospital Nagarjuna Hospital 91-9848129790

"Consultant Department nhjagan@hotmail.com
of Gastroentrology ,
Nagarjuna Hospital,
Kanuru Vijayawada,
Andhra Pradesh ,
page 2 / 6
PDF of Trial
Postal Code : %20007,

India
Krishna
ANDHRA PRADESH
nepoya Specialty Yenepoya Specialty 91-9731231769
spital Hospital, Kodialbail, 0824-2496800
Mangalore - 575 003, drvijayr1@yahoo.com
India
Dakshina Kannada
KARNATAKA

Committee?
Date
25/11/2011
Condition
Inflammatory Bowel Disease (IBD) with iron
deficiency anemia
page 3 / 6
PDF of Trial
Name Details
Iron isomaltoside 1000 Administered as 500 mg
(Monofer®) intravenous bolus injections
Frequency :- Once Duration:-
Once in study
Iron isomaltoside 1000 Administered as 1000 mg

(Monofer®) intravenous infusions
Frequency :- Once Duration:-
Once in study
NA NA
Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
1. Men and women, aged more than 18 years. 2. Subjects
diagnosed with inflammatory bowel disease and mild to moderate
disease activity (defined as a score of less than or equal to 5 on the
Harvey-Bradshaw index for Crohn’s disease and a Mayo score
(subscore without endoscopy) of less than or equal to 6 for ulcerative
colitis). 3. Weight above 50 kg. 4. Hb <12 g/dL. 5.
Transferrin saturation (TfS) <20%. 6. Life expectancy beyond
12 months by investigator’s judgment. 7. Willingness to
participate after informed consent 
Exclusion Criteria
1. Anaemia predominantly caused by factors other than iron
deficiency anaemia.
2. Iron overload or disturbances in utilisation of iron (e.g.
haemochromatosis and haemosiderosis).
3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran
or iron mono- or disaccharide complexes).
4. Known hypersensitivity to any excipients in the investigational
drug products.
5. Subjects with a history of multiple allergies.
6. Active Intestinal Tuberculosis.
7. Active intestinal amoebic infections.
8. Decompensated liver cirrhosis and hepatitis (Alanine
Aminotransferase (ALT) > 3 times upper normal limit).
9. History of immunocompromise and/or history of Hepatitis B and/or
C.
10. Active acute or chronic infections [assessed by clinical
judgement and if deemed necessary by investigator, supplied with
White Blood Cells (WBC) and C-Reactive Protein (CRP)].
11. Rheumatoid arthritis with symptoms or signs of active joint
inflammation.
12. Pregnancy and nursing (To avoid pregnancy, women have to be
postmenopausal (at least 12 months must have elapsed since last
menstruation), surgically sterile, or women of child bearing potential
must use one of the following contraceptives during the whole study
period and after the study has ended for at least 5 times plasma
biological half-life (5 days) of the investigational medicinal product:
Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot
injections (prolonged-release gestagen), subdermal implantation,
vaginal ring, and transdermal patches).
13. Extensive active bleeding necessitating blood transfusion
14. Planned elective surgery during the study
15. Participation in any other clinical study within 3 months prior to
screening
16. Untreated Vitamin B12 or folate deficiency
page 4 / 6
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17. Other I.V. or oral iron treatment or blood transfusion within 4

weeks prior to screening visit
18. Erythropoietin treatment within 4 weeks prior to screening visit
19. Any other medical condition that, in the opinion of Investigator,
may cause the subject to be unsuitable for the completion of the
study or place the subject at potential risk from being in the study.
Examples include Uncontrolled Hypertension, Unstable Ischemic
Heart Disease or Uncontrolled Diabetes Mellitus.
me Timepoints
Total serum iron pharmacokinetic parameters:
AUC0-t, AUC, Cmax, tmax, Ke, and t1/2 at 30
minutes and 0 minutes predose, and at 30
minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8
hours, 24 hours, 48 hours and 72 hours post
dose
me Timepoints
Change in reticulocyte count from study drug
administration to 8, 24, 48 and 72 hours
Total urine-iron PK variables sampled
accumulatively during four time intervals
following each dosing event: 0-8h, 8-24h,
24-48h, and 48-72h
Concentration of haemoglobin (Hb), serum

ferritin, Total Iron Binding Capacity (TIBC) and
Transferrin Saturation (TfS) at 0 minutes
predose, and at 4 hours, 8 hours, 24 hours, 48
hours and 72 hours post dose
Adverse events, laboratory safety variables,

physical examination, vital signs, and
electrocardiogram (ECG)
This study is Open-label pharmacokinetic study of iron isomaltoside 1000 (Monofer®) administered
by 500 mg IV bolus injection or 1000 mg intravenous infusion to subjects with Inflammatory Bowel
page 5 / 6
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(500 mg and 1000 mg) of iron
somaltoside 1000 (Monofer®) on the
takes place in the urine after

(500 mg and 1000 mg) of iron
use of iron isomaltoside 1000

page 6 / 6
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n, 08 Jan 2023 04:56:22 GMT)
lations in the patients of Prostate
Kwath Churna in the Management of
Identifier
NIL
Dr Pradeep Dua
Research Officer (co-ordinator ACT project)
Central Council for Research in Ayurvedic Sciences (CCRAS)
Central Council for Research in Ayurvedic Sciences (CCRAS),
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy
Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block,
Janakpuri-110058 Central Council for Research in Ayurvedic
Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam
Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area,
Opposite D Block, Janakpuri-110058
West
DELHI
110058
India
011-28525831
011-28520748
duadrpradeep@gmail.com
Dr Pradeep Dua
West
DELHI
110058
India
011-28525831
011-28520748
Dr Pradeep Dua
page 1 / 5
PDF of Trial

West
DELHI
110058
India
011-28525831
011-28520748
nstitute of Ayurveda (NIA), Jaipur. 2.
ege, Paprola. 3. Shri Dharmasthala

Department of AYUSH Ministry of Health Family Welfare
Government of India
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001
Government funding agency
Address
tional Institute of Department of 09829194634

urveda (NIA), Jaipur Shalyatantra, Amer 0141-2635709
Road, Madhav Vilas drshringi1@yahoo.co.in
Palace, Jaipur-302002
Jaipur
RAJASTHAN
jiv Gandhi Department of Shalya, 09418029271

vernment Paprola, District 01894242064
st-Graduate Kangra-176115 drramesharya@gmail.c
urvedic College, Kangra om
prola HIMACHAL PRADESH
ri Dharmasthala Department of Shalya, 9448156362

anjunatheswara Thannirohalla, B.M. 08172-256464
DM) College of Road, P.B. No.-64, phk4u@rediffmail.com
urveda, Hassan Hassan-573201
Hassan
KARNATAKA

Committee?
page 2 / 5
PDF of Trial
Date
No Date Specified
Condition
Benign Prostate Hypertrophy (BPH)
Name Details
Kanchanara Guggulu Dose – 1gm (2 Tablets) twice
daily Dosage form - Tablet of
500 mg Route of Administration
– oral Time of
Administration-Twice a day after
food Anupana-Lukewarm Water
Packing form- Bottle containg
600tablets Duration of
therapy-12 weeks
Varuna Kwath Churna Dose – 25 gm twice daily

Dosage form – Kwath churna
(to be consumed as a
decoction) Route of
Administration – Oral Time of
Administration-Twice a day
before food Anupana-Lukewarm
Water Packing form-Plastic jar
of 750 gm containing 30
sachets Duration of therapy-12
weeks
Not applicable Not applicable

Inclusion Criteria
Inclusion Criteria
45.00 Year(s)
70.00 Year(s)
Male
1. Patients with age between 45 and 70 years. 2. Patients with
American Urology Association (AUA) symptom score > 8 and <
21 3. Rectal examination consistent with Benign Prostate
Hypertrophy (BPH) 4. Prostate volume > 30cc 5. Prostate
Specific Antigen (PSA) < 4 ng/ml 6. Urine flow rate of >5 to
<15ml/sec for 2 voids 7. Willing and able to participate in the
study for 16 weeks.
Exclusion Criteria
1. Patients with severe Benign Prostate H (AUA score >21)
2. Patients currently using any other form of medical therapy for
BPH/ Hair loss
page 3 / 5
PDF of Trial
3. Patients with H/O Transurethral Resection of Prostate (TURP)
4. Serum Prostate Specific Antigen (PSA) > 4 ng/ml
5. Chronic retention of urine (Post voidal urine volume > 150ml)
6. Refractory bacteriuria
7. Patients with persistent gross haematuria
8. Patients with evidence of malignancy
9. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
10. Patients with poorly controlled Hypertension ( >
11. Patients on prolonged (> 6 weeks) medication with
corticosteoids, antidepressants, anticholinergics, etc. or any other
drugs that may have an influence on the outcome of the study. 160 /
100 mm Hg)
12. Patients suffering from major systemic illness necessitating long
term drug treatment (Rheumatoid arthritis, Tuberculosis,
Psycho-Neuro-Endocrinal disorders, etc.)
13. Patients who have a past history of Atrial Fibrillation, Acute
Coronary Syndrome, Myocardial Infarction, Stroke or Severe
Arrhythmia in the last 6 months.
14. Symptomatic patient with clinical evidence of Heart failure.
15. Patients with concurrent serious hepatic disorder (defined as
Aspartate Amino Transferase (AST) and / or Alanine Amino
Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2
times upper normal limit) or Renal Disorders (defined as S.
Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled
Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease
[COPD]), or any other condition that may jeopardize the study.
16. Alcoholics and/or drug abusers.
17. H/o hypersensitivity to any of the trial drugs or their ingredients.
18. Patients who have completed participation in any other clinical
trial during the past six (06) months.
19. Any other condition which the Principal Investigator thinks may
jeopardize the study.
me Timepoints
AUA scoring is done at Baseline, at 14th day, at
28th day, at 42nd day, at 56th day, at 70th day,
at 84th day andat the end of follow up at 16
weeks.
QOL score is done at Baseline, at 84th day and
at the end of follow up period at 16 weeks.
me Timepoints
At Baseline, at 84th day and at the end of follow
up at 16 weeks.

page 4 / 5
PDF of Trial
n all the three centers.

ty under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen
), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Varuna (Crataeva nurvala), Ela (Elettaria cardamomum),
ath Churna, the classical Ayurvedic formulations which have been in use since ages and found to be useful in treating Benign Prostate
he participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the
page 5 / 5
PDF of Trial
n, 08 Jan 2023 04:57:08 GMT)
n the treatment of Benign Prostate
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Proof-of-Concept Trial to Assess the

Efficacy and Safety of 4-Weeks Treatment with AUS-131 (S-Equol) on Benign Prostatic Hyperplasia
Identifier
Protocol Number
DCGI
ClinicalTrials.gov
Ms Sushma Srikanth
Clinical Operations Manager
Novotech Clinical Research private limited
Novotech® Unit# 1103, Level 11 Prestige Meridian-1 29,M.G.Road
Bangalore,India Sushma.Srikanth@novotech-cro.com | direct: +91
80 4164 8994 | mobile: +91 988 0665889
Bangalore
KARNATAKA
560001
India
Sushma.Srikanth@novotech-cro.com
Ms Sushma Srikanth
Novotech Clinical Research private limited Unit #1103, 11th Floor,
Prestige Meridian-1, #29, M.G. Road, 560001 Bangalore, India
Phone: +91 80 4164 8996 Fax: +91 80 6688 5634
Bangalore
KARNATAKA
560001
India
Ms Sushma Srikanth
Novotech Clinical Research private limited Unit #1103, 11th Floor,
page 1 / 7
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Prestige Meridian-1, #29, M.G. Road, 560001 Bangalore, India

Phone: +91 80 4164 8996 Fax: +91 80 6688 5634
Bangalore
KARNATAKA
560001
India
9,M.G.Road Bangalore,India +91 80 4164

Ausio Pharmaceuticals LLC
1776 Mentor Ave, Suite 340 Cincinnati, OH 45212 USA
513-731-1600 513-731-0444 (fax)
Address
NIL
amdar Multispeciality Inamdar Multispeciality 02030502222

spital, Hospital, Hospital drshamsi@hotmail.com
Building S. No, 15,
Fatima Nagar, Pune -
411 040. India.
Pune
MAHARASHTRA
draprastha Apollo Indraprastha Apollo 01126925858

spitals Hospitals, Sarita Vihar, ajitsaxena@hotmail.co
Delhi-Mathura Road m
New Delhi -110076,
India
South
DELHI
S Ramaiah Memorial M S Ramaiah Memorial 08025299247
spital Hospital New BEL nagarajharohally@hotm
Road, MSRIT Post, ail.com
Bangalore - 560054,
India.
Bangalore
KARNATAKA
th G S Medical Department of Urology, 02224107495

llege and KEM 8th Floor, New Building, sujata.patwardhan@red
spital Seth G S Medical iffmail.com
College and KEM
Hospital, Acharya
Donde Marg, Parel,
Mumbai-400 012. India.
Mumbai
page 2 / 7
PDF of Trial
MAHARASHTRA
MS Hospital Department of Urology, 01416594299
SMS Hospital, JLN dryadavsms@gmail.co
Marg, Jaipur – 302004, m
Rajasthan.
Jaipur
RAJASTHAN

Committee?
Date
13/04/2012
Condition
Benign Prostatic Hyperplasia
Name Details
AUS-131 (S-equol) capsules 10 S-equol (AUS-131), the
mg BID (20 mg total daily S-enantiomer of equol, is a
dose)for oral administration for potent, selective estrogen
4 Weeks receptor (ER)-? agonist that
(Ausio) is developing for the
treatment of BPH in men.
AUS-CT-04 is a Placebo-Contro Patients in all treatment groups,

lled,Non-comparative, including placebo, may leave
Proof-of-Concept Trial the study for any reason,
including for reasons of adverse
events. Such patients will be
referred to their physician, and
page 3 / 7
PDF of Trial
provided medical advice from

the Principal Investigator,
regarding what medical
treatment (rescue strategy)
would be appropriate for their
condition.
AUS-131 (S-equol) capsules 50 S-equol (AUS-131), the

mg BID (100 mg total daily S-enantiomer of equol, is a
4 Week receptor (ER)-? agonist that
AUS-131 (S-equol) capsules S-equol (AUS-131), the
150 mg BID (300 mg total daily S-enantiomer of equol, is a
4 Weeks receptor (ER)-? agonist that
Inclusion Criteria
50.00 Year(s)
70.00 Year(s)
Male
Inclusion Criteria A patient will be eligible for study entry if all of
the following inclusion criteria are met: 1. Is male > 50 and
?70 years of age at Screening. 2. Has a normal digital rectal
exam with the exception of prostate enlargement. 3. Has
suffered from symptoms of BPH for at least the 6 months before
Screening (e.g., micturition disturbances such as daytime frequency,
nocturia, urgency, difficulty initiating micturition, impaired quality of
the urinary stream, feeling of incomplete voiding, or interruption of
the urinary stream). 4. Has a prostate volume ? 20 mL and ? 70
mL as assessed by ultrasound. 5. Has a serum PSA
concentration > 1.5 ng/mL and ? 10 ng/mL at Screening. 6. Has
an IPSS ? 13 at Screening and Baseline. 7. Has a Qmax > 5
cc/sec and < 15 cc/sec with a voided volume ? 125 cc at Screening
(and Baseline, if applicable). 8. Is able to provide written
informed consent to participate in the study and able to understand
the procedures and study requirements. 9. Must voluntarily sign
and date an informed consent form (ICF) that is approved by an
Institutional Review Board (IRB) or Independent Ethics Committee
(IEC) before the conduct of any study procedure. 10. Is willing
and able to comply with all study requirements and instructions of the
site study staff.
Exclusion Criteria
Exclusion Criteria
A patient will not be eligible for study entry if any of the following
exclusion criteria are met:
1. Has a known history of allergic reaction or clinically significant
intolerance to ingredients of the study drug.
2. Neurogenic bladder dysfunction.
3. Has bladder neck contracture or urethral stricture.
4. Has acute or chronic prostatitis or urinary tract infection.
5. Has, or has a history of, prostate cancer or carcinoma of the
prostate suspected on digital rectal exam or transrectal ultrasound,
or has a serum PSA concentration > 10 ng/mL; patients with a PSA
concentration > 4 ng/mL and ? 10 ng/mL must have prostate cancer
page 4 / 7
ttp://ctri.nic.in
page 5 / 7
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days before Screening.
me Timepoints
Day 28 ±2 days
me Timepoints
Change from Baseline in prostate size
Change from Baseline in Qmax

US-131 is well tolerated and presents an
cceptable safety profile was reported in

to placebo and only 2 mild TEAE
to study drug for both studies. Since the
the placebo or drug groups. The potential
ymptoms of benign prostatic hyperplasia
cedented.
T01, indicate that, based on the T1/2 for
adequate systemic exposure at steady
S-CT02, confirmed a BID dosing regimen
current study are comparable to
page 6 / 7
PDF of Trial
ith dosing cohorts of 10, 20, 40, 80, or 160 mg

PK profiles compared to the younger group
-CT01. However, the safety profile was similar
ax were not significantly different between the
ate doses in the multidose Phase 1 study,
older individuals compared to the younger
ase 1 studies.
page 7 / 7
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n, 08 Jan 2023 04:57:31 GMT)
apsule Outflo in Patients with Benign
Study to Evaluate the Safety and Efficacy

plasia.
Identifier
Protocol Number

Dr Shailesh A Shah
Chairman
Bodyline Hospitals
Nava Vikas Gruh Road, Opp. Annapurna Hall, Nr. Dev Status,Paldi,
Ahmedabad-380007,India
Ahmadabad
GUJARAT
380007
India
079-26651520
079-26640558
shaileshshahuro@yahoo.com
Mr Dipak Patel
R&D Manager
Sahajanand Life Sciences Private Limited
Sahajanand Estate, Plot No. 53-57, Wakhariawadi, Near Dabholi
Char-rasta, Ved Road,Surat-395009
Surat
GUJARAT
395004
India
dipak.patel@sahbio.com
Dr Nirav Joshi
Co-investigator
Sahana Clinical Research
Sahana Clinical Research 101, Tirupati Chambers, Sub-jail
cross-roads, Surat - 395 002
Surat
GUJARAT
395004
India
page 1 / 5
PDF of Trial
9879839644
nirav.joshi@sahanacro.com

Sahajanand Life Sciences Private Limited
Sahajanand Estate, Plot 53-57, Wakhariawadi, Near Dabholi
Char-rasta, Nani Ved, Ved Road, Surat - 395004, Gujarat, India
Address
NIL
dyline Hospitals Department of Urology, 079-26651520

3rd Floor, Nava Vikas shaileshshahuro@yaho
Gruh Road, Opp. o.com
Annapurna Hall, Nr.
Dev Status,Paldi,
Ahmadabad
GUJARAT
itale Clinic Basement,165 D 0217-2319251
Railway Lines, Saat drgrsharma@hotmail.co
Rasta, Opposite Bus m
Stand, Solapur –
413001
Solapur
MAHARASHTRA
sai Uroligical and Urological Department, 9624062118

aternity Hospital 2nd and 3rd Floor, raseshdesai61@hotmai
Abhinav Complex l.com
Kamalkunj Society,
Delux Circle,
Nizampura
Vadodara
GUJARAT
Raghoji Kidney Basement, 146/2 0217-2314911

spital and Research Railway Lines, Near drvdraghoji@gmail.com
ntre Old R.T.O., Solapur
Solapur
MAHARASHTRA
uljibhai Patel Department of Urology, 0268-2520323

ological Hospital Dr. Virendra Desai rbsabnis@gmail.com
Road, Nadiad 387001
Kheda
GUJARAT
mved Hospital Urology Department 079-26420285

2nd Floor, Nr. Stadium drjanakddesai@gmail.c
circle, Navarangpura, om
Ahmedabad,
Ahmadabad
GUJARAT
page 2 / 5
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Committee?
Date
page 3 / 5
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No Date Specified
Condition
Name Details
Capsule Outflo (1 BD) Total duration of therapy 90
days. Poly-herbal formulation
containing 1. Boerhavia diffusa
2. Crateva nurvala 3. Tribulus
terrestris 4. Curucma longa 5.
Tinospora cordifolia 6. Saw
palmetto
Capsule Outflo (2 BD) Total duration of therapy 90

days. Poly-herbal formulation
containing 1. Boerhavia diffusa
2. Crateva nurvala 3. Tribulus
terrestris 4. Curucma longa 5.
Tinospora cordifolia 6. Saw
palmetto
Inclusion Criteria
40.00 Year(s)
99.00 Year(s)
Male
•Male patients with aged ?40 •New patients diagnosed
with BPH, naïve to any other treatments for BPH 
•Patients with International Prostate Symptom Score (IPSS) greater
than 7 and less than 18 •Patients with Prostate volume
less than 40 cc •Patients with Qmax of 8-12 ml/sec 
 •Patients with PVUR less than 200 ml •Patients
willing to give written informed consent and willing to follow up 
Exclusion Criteria
•Patients with prostatic cancer; neurogenic bladder; bladder cancer;
bladder stones; urethral strictures; neurological conditions that might
interfere with normal voiding
•Symptomatic coronary arterial disease, stroke, and cardiovascular
events
•Current treatment with systemic corticosteroids or herbal
(alternative) medicines
•Patients with abnormal renal and hepatic function
•Any significant disease or disorder that may jeopardize the safety of
the subject
•Patients with drug and alcohol abuse
•Any psychiatric disorder
•Patients who have participated in any clinical trial in the past 3
months
page 4 / 5
PDF of Trial
me Timepoints
Change in International Prostate Symptom Score
(IPSS)(baseline - 1 month - 2 months - 3months)
Change in Uroflowmetry parameters (baseline -
1 month - 2 months - 3months)
me Timepoints
Baseline - End of Study
entric trial comparing the safety
Flo (2 BD) 75 patients with Benign
of the trial is to compare the
D) vs. OutFlo (2 BD) . Primary
in Qmax and post void residual
he base-line to the end of the
measure.
page 5 / 5
PDF of Trial
n, 08 Jan 2023 04:57:42 GMT)
ompared with Mitomycin C in the

efractory non-muscle invasive bladder
Multicenter Study To Evaluate The

h Mitomycin C In The Intravesical
y Non-Muscle Invasive Bladder Cancer
Identifier
Protocol Number

Manali Rane
Project Manager
DiagnoSearch Life Sciences Pvt. Ltd.
DiagnoSearch Life Sciences Pvt. Ltd 702, Dosti Pinnacle E-7, Road
22, Wagle EstateThane – 400604. Tel#: 022-6777 6300
Thane
MAHARASHTRA
400604
India
02267776300
02267776303
manali.rane@diagnosearch.com
Manali Rane
Project Manager
DiagnoSearch Life Sciences Pvt. Ltd.
DiagnoSearch Life Sciences Pvt. Ltd 702, Dosti Pinnacle E-7, Road
22, Wagle EstateThane – 400604. Tel#: 022-6777 6300
MAHARASHTRA
400604
India
page 1 / 7
PDF of Trial
02267776300
02267776303
manali.rane@diagnosearch.com

Endo Pharmaceuticals Inc
Endo Pharmaceuticals Inc. 100 Endo Boulevard Chadds Ford, PA
19317; United States of America Telephone: 610-558-9800
Address
DiagnoSearch Life Sciences Pvt. Ltd Unit No.
702, 7th Floor, Dosti Pinnacle, Plot No. E-7,
Road No. 22, Wagle Industrial Estate, Thane –
400 604

hatrapati Shahuji (Erstwhile King 9415028046
aharaj Medical George’s Medical pahwakgmu@yahoo.co
iversity University), New .in
Surgical Block, General
Surgery, Chowk,
Lucknow – 226003
Uttar Pradesh, India
Lucknow
UTTAR PRADESH
ristian Medical Department of Urology, 0161-5026999

llege & Hospital Brown Road, Ludhiana 0161-2609958
– 141 008, Punjab, kjmammen@gmail.com
India.
Ludhiana
PUNJAB
Ram Manohar Lohia Department of Urology, 011-23404323

spital & PGIMER Room no. 31, OPD 011-23360067
Block, Baba Kharag drsoodr@yahoo.com
Singh Marg, New Delhi
– 110001, India
New Delhi
DELHI
S Ramaiah Medical New BEL Road, MSRIT 080-22183065

llege and Hospitals Post, 080-22183276
Bangalore-560054, arunacr1@gmail.com
Karnataka, India
Bangalore
KARNATAKA
page 2 / 7
PDF of Trial
onilek Hospital & Department of 0141-2651393

search Centre Research, Room No 0141-2652181
105, Basement, sltolani@gmail.com
Sector-4, Jawahar
Nagar, Jaipur-302004,
Rajasthan, India
Jaipur
RAJASTHAN
zams Institute of Dept. of Urology and 040-23489016

edical Sciences Renal Transplantation, 040-23323016
Punjagutta, pvlnm@rediffmail.com
Hyderabad-500082,
Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH
jiv Gandhi Cancer B Block Basement, Old 011-47022027
titute and Research Building,Sector 5, 011-27054092
ntre Rohini, New Delhi – dr_rawal@hotmail.com
110085, India
New Delhi
DELHI
ta Memorial Hospital Homi Bhabha Block, 022-24177000

2nd Floor, Department 022-24146937
of Uro-Oncology, Dr. gkbakshi1973@gmail.c
Ernest Borges Marg, om
Parel,Mumbai-400012,
Maharashtra, India
Mumbai
MAHARASHTRA
ocare Hospital Vidyanagar Main Road, 0281-2466990

Oppo. Gokul Hospital, 0281-2467060
Rajkot-360002, Gujarat, jcamlani@yahoo.com
India
Rajkot
GUJARAT
M. Medical College & , Sri Aurobindo Marg, 01126190954

fdarjang Hospital New Delhi - 110029 01126190954
New Delhi nayankm@yahoo.co.in
DELHI
oodlands Department of Urology, 91-33-24567075

ultispeciality Hospital 8/5, Alipore road, 033-24567090
mited Kolkata – 700 027 West kksarkar@gmail.com
Bengal, India.
Kolkata
WEST BENGAL

Committee?
page 3 / 7
PDF of Trial

view
Date
17/07/2012
Condition
BCG Recurrent Or Refractory Non-Muscle
Invasive Bladder Cancer
Name Details
EN3348 Name of Active Ingredient:
Mycobacterial Cell Wall-DNA
Complex Route: Intravesical
administration Dose:
8mg/instillation Frequency:
Induction Phase: Subjects
would receive 1 dose/week for 6
weeks of Maintenance Phase:
Subjects will receive 1
dose/month for 10 months
EN3348 Name of Active Ingredient:
Mycobacterial Cell Wall-DNA
Complex Route: Intravesical
administration Dose:
8mg/instillation Frequency:
Induction Phase: Subjects
would receive 1 dose/week for 6
weeks of Maintenance Phase:
Subjects will receive 1
dose/month for 10 months
Mitomycin C Chemotherapeutic agent Route:

Intravesical administration
Dose: 40mg/instillation
page 4 / 7
PDF of Trial
Frequency: Induction Phase:

Subjects would receive 1
dose/week for 6 weeks
Maintenance Phase: Subjects
will receive 1 dose/month for 10
months
Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
Subjects are eligible for inclusion into the study if the following
criteria are met: 1. Males and females who are 18 years of age
or older at time of consent signing 2. Have either BCG recurrent
or refractory NMIBC: a. Refractory disease is defined as
evidence of persistent high grade bladder cancer (Ta HG, T1 and/or
CIS) at least 6 months from the start of full induction course of BCG1
with or without maintenance/ re-treatment at 3 months. b.
Recurrent disease is defined as reappearance of disease after
achieving a tumor-free status by 6 months following a full induction
course of BCG1 with or without maintenance/ re-treatment at 3
months. Subjects with recurrent disease must have recurred within
18 months following the last dose of BCG. 1 A full induction
course of BCG is defined as at least 5 out of 6 total expected
instillations of BCG within a period of 2 months, regardless of dose
strength. 3. Have histologically confirmed NMIBC (according to
2004 WHO classification) within 8 weeks prior to randomization: 
a. High grade Ta papillary lesion(s) b. High or low grade T1
papillary lesion(s) (biopsy sample must include evidence of
muscularis propria) c. CIS, with or without Ta or T1 papillary
tumor(s) of any grade 4. Have had all visible papillary and
resectable CIS lesion(s) removed by TURBT within 8 weeks prior to
randomization 5. Available for the duration of the study
including follow-up (approximately 36 months) 6. Have an
Eastern Cooperative Oncology Group (ECOG) performance status
grade of 2 or less 7. Have no evidence of urothelial carcinoma
involving the upper urinary tract or the urethra (confirmed by
extravesical work up, which may include radiological imaging and/or
biopsy) within 6 months prior to randomization: a. If previous
work up occurred more than 6 months prior to randomization,
extravesical work up must be repeated prior to randomization in
order to determine eligibility 8. Subjects (male and female) of
child-bearing potential (including female subjects who are
post-menopausal for less than 1 year) must be willing to practice
effective contraception (as defined by the Investigator) during the
study and be willing and able to continue contraception for 30 days
after their last dose of study treatment. 9. Is able to understand
and give written informed consent 
Exclusion Criteria
Subjects meeting the following criteria will be excluded from
participation in the study:
1. Current or previous history of muscle invasive bladder tumors
2. Current or previous history of positive lymph nodes and/or
metastatic bladder cancer
3. Current evidence of pure squamous cell carcinoma, pure
adenocarcinoma or pure undifferentiated carcinoma of the bladder
4. Currently receiving systemic anti-cancer therapy
(cytotoxic/cytostatic or immunotherapy)
5. Currently receiving treatment with a prohibited therapy
. 6. Current or prior history of systemic lupus erythematosus
page 5 / 7
PDF of Trial
7. Systemic immunotherapy within 6 months of randomization

8. Treatment with an investigational agent within 30 days or 5 half
lives from randomization, whichever is longer
9. Prior treatment with an intravesical chemotherapeutic agent within
3 months of
randomization, except for single perioperative dose of chemotherapy
immediately post-TURBT
10. Prior treatment with EN3348 (MCC) or any other mycobacterial
cell wall composition or formulation
11. Refractory to Mitomycin C (failure to achieve tumor-free status
following minimum of a 6-week induction course of mitomycin C)
12. Contraindication to mitomycin C
13. Untreated urinary tract or bladder infection
14. ANC 1000/µL and hemoglobin 10 g/dL
15. Known cardiovascular disease such as myocardial infarction
within the past 3 months, unstable angina pectoris, congestive heart
failure (New York Heart Association [NYHA] Class III or IV) or
uncontrolled cardiac arrhythmia
16. Female subjects who are pregnant or lactating
17. Congenital or acquired immune deficiency
18. Current or history of documented or suspected malignancy of
any organ system (diagnosed, treated or untreated) within the past 5
years (with the exception of localized transitional cell carcinoma of
the ureter treated with ureterectomy or nephroureterectomy,
adequately treated basal cell or squamous cell carcinoma of the skin
or asymptomatic non-metastatic prostrate cancer either previously
successfully treated or currently under active surveillance or
receiving hormone therapy only)
19. Bladder contracture or history of an inability to retain the instillate
for a minimum of 1 hour, even with premedication
20. Inability to tolerate intravesical administration or intravesical
surgical manipulation (cystoscopy or biopsy)
21. Clinically significant active infections
22. Any medical or psychiatric condition which, in the opinion of the
investigator, would preclude the participant from adhering to the
protocol or completing the trial per protocol
me Timepoints
The primary outcome is measured as "event free
survival"
Event free survival is measured from the time of
randomization till an occurance of an event in a
subject.
Event is defined as tumor recurrence, tumor
progression to muscle invasive bladder cancer
(MIBC) or death, whichever occurs first.
me Timepoints
me Timepoints
• Event-free survival rate at 1 and 2 years
• Recurrence rate at 1 and 2 years
• Progression rate at 1 and 2 years – number of
subjects progressing to muscle invasive
disease (T2 or higher) or metastatic bladder
cancer observed outside of bladder
• Time to cystectomy – interval from
page 6 / 7
PDF of Trial
randomization to cystectomy
• Overall survival

en-label, multicenter study that will be

s worldwide. Subjects with either BCG
w or high grade, CIS) will be eligible
defined as failure to achieve
ate BCG therapy (minimum of 5
ond course (induction or maintenance)
sease after achieving a tumor-free

therapy. Subjects with recurrent
wing the last dose of BCG.
e randomization will be 1:1 and
a, Europe), tumor pathology (CIS
sus recurrent), and prior intravesical
se of 6 weeks, induction phase of 6

w up phase of up to approximately 24
en-label, multicenter study that will be
s worldwide. Subjects with either BCG
w or high grade, CIS) will be eligible
defined as failure to achieve
ate BCG therapy (minimum of 5
ond course (induction or maintenance)
sease after achieving a tumor-free

therapy. Subjects with recurrent
wing the last dose of BCG.
e randomization will be 1:1 and
a, Europe), tumor pathology (CIS
sus recurrent), and prior intravesical
se of 6 weeks, induction phase of 6

w up phase of up to approximately 24
page 7 / 7
PDF of Trial
n, 08 Jan 2023 04:57:53 GMT)
study medication (Dose I & II) compared to
ed parallel group multi-centric study to

EXTRA (Dose I & II) compared to placebo
Identifier
Protocol Number
Dr Navneet Sonawane
Trial Coordinator
Vedic Lifesciences Pvt. Ltd.
Vedic Lifesciences Pvt. Ltd. 118 Morya House, Off Link Road,
Andheri (W), Mumbai-400053
Mumbai
MAHARASHTRA
400053
India
02242025706
navneet.s@vediclifesciences.com
Dr Navneet Sonawane
Trial Coordinator
MAHARASHTRA
400053
India
02242025706
Dr Navneet Sonawane
Trial Coordinator
MAHARASHTRA
400053
page 1 / 4
PDF of Trial
India
02242025706
nendaal, The Netherlands.
Frutarom Netherlands BV
Landjuweel 5 3905 PE Veenendaal The Netherlands
Other [Nutraceutical Industry - Global]
Address
NIL
ncelot Kidney and GI 111/C, Lancelot, 022-28016266

ntre S.V.Road, Borivli ubkhanna@gmail.com
(West), Mumbai – 400
062
Mumbai
MAHARASHTRA
Y.L.Nair charitable Dr.A.L.Nair Road, 022-22067676

spital and Topiwala Mumbai – 400 008. mukundandankar@gma
edical College Mumbai il.com
MAHARASHTRA
Shrotri Urology Hospital 24, Parvati Darshan, 9822063622

Velankar Nagar, Indira rajesh.shrotri@yahoo.in
Bungalow, Near
Laxminarayan Theatre,
Pune- 411 009.
Pune
MAHARASHTRA
uktai Hospital Plot no. 11, Opp. Fame 9822651494

Adlaboratorys, Shivaji patilchetan@yahoo.co
Nagar, Nasik-Pune m
Road, Nasik – 422 006.
Nashik
MAHARASHTRA
raddha Hospital Shraddha Hospital and 9822078819
ICU, Dept of Surgery, rbuttamani@gmail.com
Hospital Road,
Ulhasnagar – 421 003
Thane
MAHARASHTRA
rdesai Clinic Shymala Apartment, 020-25655665

968/3, Senapati Bapat milindbbapat@yahoo.c
Road, Pune- 411016 o.in
Pune
MAHARASHTRA

Committee?
page 2 / 4
PDF of Trial
Date
No Date Specified
Condition
Name Details
LinumLife Extra - Investigational 500mg capsule in the morning
product daily for 8 weeks
Carboxy Methyl Cellulose - 500mg capsule in the morning
Placebo daily for 8 weeks
Inclusion Criteria
45.00 Year(s)
75.00 Year(s)
Male
• Ages eligible for Study : 45 Years - 75 Years • Genders
eligible for Study : Male • Newly diagnosed cases of BPH (i.e.
Fresh cases) diagnosed by USG along with documented symptoms
of BPH (frequency; urgency; night time urination; reduced flow
etc) • American Urological Association (AUA) Symptom Index
Score ? 13. • PSA equal to or less than 4 ng/mL ( 0 to ? 4
ng/ml) • Residual urine volume > 30 ml to <200 ml post
voiding 
Exclusion Criteria
Subjects on 5 –alpha reductase inhibitors. Subjects on alpha 1
adrenergic antagonist (alpha blockers.
Subjects on combination of 5 –alpha reductase inhibitors and
alpha-blockers(K/c/o BPH on medications)
Subjects on anti-cholinergics
me Timepoints
Baseline to end of treatment (Day 56).
page 3 / 4
PDF of Trial
me Timepoints
Baseline to end of treatment (Day 56).
ociated with bothersome lower
quality of life by interfering with
The prevalence of bothersome
ent of BPH is currently
and morbidity {complications
ted with the “gold standard”
Prostate (TURP)} but this along
ave adverse effects including
such as retrograde ejaculation,
es. Hence it is the need of time
h minimal side effects. There is
ally for subjects unfit for surgery
drugs do provide symptomatic
rtant target to be achieved in
m is to assess these
mptoms of BPH and at the
s study we are trying to
nitor whether the Investigational
ses) can maintain and further
cts with BPH
page 4 / 4
PDF of Trial
n, 08 Jan 2023 04:58:01 GMT)
hemic stroke Vs Hemorrhagic stroke. A
Identifier
Protocol Number

Dr JD Mukherji
Senior Consultant and Head Department of Neurology
Max Super Speciality hospital
Max Super Speciality Hospita 2 Press Enclave Road Saket New
Delhi 110017 Max Super Speciality Hospita 2 Press Enclave Road
Saket New Delhi 110017
South
DELHI
110017
India
9810950742
jd.mukherji@maxhealthcare.com
Karan Sharma
Clinical research Trainee
South
DELHI
110017
India
9711252764
krnsharma87@gmail.com
Dr JD Mukherji
Senior Consultant and Head Department of Neurology
DELHI
page 1 / 4
PDF of Trial
110017
India
9810950742
jd.mukherji@maxhealthcare.com

NA
NA
Other [NA]
Address
NIL
ax Super Speciality Max Super Speciality 9810950742

spital, Department of Hospital 2 Press jd.mukherji@maxhealth
urology, West Block Enclave Road Saket care.com
New Delhi 110017
South
DELHI

Committee?
Date
No Date Specified
Condition
Condition
Ischemic and Hemorrhagic stroke
Name Details
18.00 Year(s)
90.00 Year(s)
Both
All Ischemic and Hemorrhagic stroke patients admitted and treated in
Department of Neurology, Max super Specialty Hospital, Saket, New
Delhi 
Exclusion Criteria
1. Patients undergoing Neuro-surgical management
2. Patients of SAH.
3. Incomplete patient clinical data.
page 2 / 4
PDF of Trial
me Timepoints
At admission and discharge from hospital
me Timepoints
At admission and discharge from hospital.

As the morbidity and the recovery patterns of ischemic and hemorrhagic stroke are different from
each other, this retrospective observational study aims to determine and compare the outcome or
disability on discharge/death, from hospital between IS and ICH in a hospital based study.
This is a retrospective observational study on IS and HS patients, who were treated in Department
of Neurology of Max Super Specialty Hospital, Saket, between August 2011 and January 2012.
Primary objective is to study the outcome of hospitalization at discharge/death in patients of
Ischemic stroke (IS) vs Hemorrhagic stroke
Inclusion Criteria
1. All Ischemic and Hemorrhagic stroke patients admitted and treated in Department of
page 3 / 4
PDF of Trial
page 4 / 4
PDF of Trial
n, 08 Jan 2023 04:58:18 GMT)
w or Worsening Lens Opacifications in

Denosumab for Bone Loss due to
w or Worsening Lens Opacifications in

Denosumab for Bone Loss due to
Identifier
Protocol Number
ClinicalTrials.gov

Sagar Patil
Amgen Technology Pvt. Ltd
A Wing, Level 4,Dynasty Business Park,A.K Road, Andheri (East)
400059 India
Mumbai
MAHARASHTRA
400059
India
912267869351
91-22-67869138
psagar@amgen.com
Dr Veena Jaguste
Dir Development Operations
Amgen Technology Pvt. Ltd
A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East)
Mumbai,India
Mumbai
MAHARASHTRA
page 1 / 5
PDF of Trial
400059
India
91-22-67869353
991-22-67869138
vjaguste@amgen.com

Amgen Technology Pvt Ltd
A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East)
Mumbai | India | PIN : 400 059
Other [Global Biotech Company]
Address
none
page 2 / 5
PDF of Trial
ristian Medical Department of Urology, 9814034185

lege Hospital Christian Medical 01615026999
college Hospital, kjmammen@gmail.com
Ludhiana - 141 008,
Punjab, Inida.
Ludhiana
PUNJAB
rie Manavata Cancer Opp Mahamarg bus 9823061929
ntre stand, Mumbai Naka, 0253-2592666
Nashik - 422 004, drraj@manavatacancer
Maharastra, India. centre.com
Nashik
MAHARASHTRA
CG-Bangalore HCG Towers, 1st Floor 09731209671

titute of Oncology Triesta Sciences,, # 8 drraghunathsk@yahoo.
P.Kalinga Rao Road, S com
ampangiramnagar-5600
27 Bangalore.
Karnataka, India
Bangalore
KARNATAKA
i Urology Hospital Sai Urology Hospital, 9822321224

opposite Cada Office, 240-2452613
Vishal Nagar, Gajanan drabhaymahajan@gmai
Maharaj Mandir Road, l.com
Aurangabad - 431005,
Maharashtra, India.
Aurangabad
MAHARASHTRA

Committee?
page 3 / 5
PDF of Trial
Date
16/04/2012
Condition
Condition
Cancer Cataract Low Bone Mineral Density
Osteopenia Osteoporosis Prostate Cancer
Malignant neoplasm of prostate
Name Details
Active Comparator: Arm A Biological: Denosumab
Denosumab 60 mg Denosumab 60 mg is
subcutaneously on Day 1 and administered subcutaneously on
Month 6 Day 1 and Month 6.
Placebo Comparator: Arm B Biological: Placebo Placebo
Placebo subcutaneously on Day administered subcutaneously on
1 and Month 6. Day 1 and Month 6.
Inclusion Criteria
30.00 Year(s)
80.00 Year(s)
Male
Men more than 30 years of age with non-metastatic prostate cancer
 Have undergone bilateral orchiectomy or initiated ADT with
GnRH agonists and is expected to continue on ADT for at least 12
months ECOG score (0,1 or 2) Baseline BCVA of 20/40,
(6/12 or 0.5 on the decimal scale) or better using the ETDRS charts
at 4 meters in one eye with a natural, intact lens Bone Mineral
Density (BMD) requirements: If 70 years: BMD T-score at the
lumbar spine, total hip, or femoral neck 2.5 and 1.0 (osteopenia) If 70
years of age: BMD T-score at lumbar spine and total hip and femoral
neck -2.5 At least 2 evaluable lumbar vertebrae 
Exclusion Criteria
Screening LOCS III grade of 3.5 for posterior subcapsular cataract,
4.0 for cortical cataract, or 4.5 for nuclear opalescence
Bone Mineral Density (BMD) T-score -2.5 at lumbar spine andor total
hip andor femoral neck (osteoporosis)
evidence of distant metastases
Known osteonecrosis of the jaw (ONJ)
Unstable system disease including active infection, uncontrolled
hypertension, unstable angina, congestive heart failure, or
myocardial infarction within 6 months before randomization
Incisional eye surgery in both eyes or cataract surgery in both eyes
Current administration of IV bisphosphonates
PSA 5ngmL at screening
try Operator Blinded

me Timepoints
development or progression by month 12
exceeding a predefined level at any of 3 key lens
locations using LOCS III score.
me Timepoints
[ Time Frame: One year ] [ Designated as safety
issue: Yes ]
page 4 / 5
PDF of Trial
[ Time Frame: One year ] [ Designated as safety

issue: Yes ]
trolled study to evaluate new or worsenin

te cancer receiving denosumab for bone
ary, India, Latvia, Mexico, New Zealand, Poland, Russia, Slovakia, Slovenia, S
e basis of screening Lens Opacities Classification System (LOCS) III status (< 3.0 at all sites
page 5 / 5
PDF of Trial
n, 08 Jan 2023 04:58:23 GMT)

page 1 / 1
PDF of Trial
n, 08 Jan 2023 04:58:35 GMT)
ents at High Risk of Recurrent Renal Cell
zed Double-blind Phase 3 Study of

Recurrent RCC
Identifier
Protocol Number
ClinicalTrials.gov
Dr Shrikant P Kasawlekar
Clinical Project Manager
IQVIA RDS (India) Private Limited
301-A-1,Leela Business Park MV Road, Andheri (East)
Mumbai-400059
Mumbai
MAHARASHTRA
400059
India
09920287330
022-66466475
Shrikant.Kasawlekar@quintiles.com
Dr Shoibal Mukherjee
Vice President, Medical
8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II
Gurgaon, Haryana India - 122002
Gurgaon
HARYANA
122002
India
91-7838652395
shoibal.mukherjee@quintiles.com
Suchela Srivatsa
Director – Clinical Operations
301-A-1, Leela Business Park MV Road, Andheri East, Mumbai
400059
Mumbai
MAHARASHTRA
400059
page 1 / 10
PDF of Trial
India
91-9820712114
91-22-56774343
suchela.srivatsa@quintiles.com
quare, PO Box 2681, Grand Cayman,
E, 42nd street, New York

SFJ Pharma Ltd II
Boundary Hall, 2nd Floor, Cricket Square, PO Box 2681, Grand
Cayman, KY1-1111, Cayman Islands, on behalf of Pfizer Inc., 235 E,
42nd street, New York
Address
B-101-106, Shapath IV, Sarkhej-Gandhinagar
Road, Ahmedabad - 380051, Gujarat

arat Cancer Hospital Manav Daya Trust 09900991887
Research Institute Complex, Surat Bardoli 0261-2641004
Road, Saroli – 395010, tanveermaksud@yahoo
Surat, Gujarat, India .com
Surat
GUJARAT
BI General Hospital & 16-3-991/1/C, 09246243034

ncer Centre Government Printing 040-24410792
Press Road, Malakpet, sureshattili@yahoo.com
Hyderabad-500024,
Hyderabad
ANDHRA PRADESH
partment of Medical Amrita Institute of 09895367090

cology, Amrita Medical Sciences and 0484-2802120
titute of Medical Research Center, pavithrank@aims.amrit
iences and Research Ponnekkara P.O., Kochi a.edu
nter – 682041, Kerala, India
Ernakulam
KERALA
partment of Medical Apollo Hospitals, 09848018804

cology, Apollo Jubilee Hills, 040-23608050
alth City Hyderabad – 500096, Spectra_hyderabad@re
Andhra Pradesh, India. diffmail.com
Hyderabad
ANDHRA PRADESH
partment of Medical Padma Complex, 320, 040-23489016

cology, Apollo Anna Salai, Chennai – 044-24362424
page 2 / 10
PDF of Trial
0035, Tamil Nadu, ashaherf@gmail.com

dia.
ennai
MIL NADU
/1, Humayun Kabir 09830055035
rani, New Alipore, 033-23997009
ock – G, Kolkata – drcgoswami@gmail.co
0053,West Bengal, m
dia
lkata
EST BENGAL
avar, Mangalore - 09880345666
5001, Karnataka, 0824-2425092
dia drkrishnaprasad@hotm
kshina Kannada ail.com
RNATAKA
a Hall, Nesbit Road, 09820344570

azagaon, Mumbai – 022-23743820
0010, Maharashtra, drboman@hotmail.com
dia
umbai
AHARASHTRA
irdi Sai Baba Cancer 09448252736

spital & Research 0820-2922928
ntre (A Unit of donaldjf@gmail.com
sturba Hospital),
adhav Nagar, Manipal
576104, Karnataka,
dia
upi
RNATAKA
ristian Medical 09814034185

llege & Hospital, 0161-5010909
dhiana - 141008, kimammen@gmail.com
njab, India
dhiana
UNJAB
ng George’s Medical 09839181465

iversity, Chowk, 0522-2256543
cknow – 226003, goelapul1@rediffmail.c
ar Pradesh Uttar om
adesh, India
cknow
TAR PRADESH
hangir Hospital 09822406084

emises, 32 Sassoon 020-26059319
ad, Pune – 411001, kashyapi1@gmail.com
aharashtra, India
ne
AHARASHTRA
ree Krishna Hospital 09427042969

Medical Research 02692-223466
ntre, Gokal Nagar, ritu80@rediffmail.com
ramsad – 388325,
jarat, India
and
UJARAT
7, MVP Colony, 09848191287

sakhapatnam – 0891-2506103
page 3 / 10
PDF of Trial
search Institute 530017, Andhra muralivoonna@yahoo.c

Pradesh, India. om
Visakhapatnam
ANDHRA PRADESH
anipal Hospital 98, HAL Airport Road, 09880463958
Bangalore –560017, 080-25266757
Karnataka, India amit.rauthan@manipalh
Bangalore ospitals.com
KARNATAKA
oolchand Kharaiti Moolchand Medcity 09811065538

m Hospital & Hospital, Lajpat Nagar 011-42000300
urvedic Research III, Main Ring Road, amitbharga@gmail.com
New Delhi – 110024,
India
New Delhi
DELHI
by Hall Clinic 40, Sassoon Road, 09823133390

Pune – 411001, 020-66455631
Maharashtra, India minishjain009@gmail.c
Pune om
MAHARASHTRA
AROC Cancer S.K. Soni Hospital, Sect 09829060128

ntre -5 Vidhyadhar Nagar, 0141-2233337
Sikar Road, Jaipur – anishmaru@yahoo.com
302013, Rajasthan,
India
Jaipur
RAJASTHAN
atabdi Super Suyojit City Centre, 09822012427

eciality Hospital Opp. Mahamarg Bus 0253-2502105
Stand, Mumbai Naka, shaileshbondarde@yah
Nashik – 422005, oo.com
Maharashtra, India
Nashik
MAHARASHTRA

Committee?

view
page 4 / 10
PDF of Trial
/05/2012 No
/06/2012 No
/04/2012 No
Date Specified No
/03/2012 No
/08/2012 No
Date Specified No
/05/2012 No
page 5 / 10
PDF of Trial
Date Specified No
/04/2012 No
/07/2012 No
/05/2012 No
Date Specified No
Date Specified No
/04/2012 No
page 6 / 10
PDF of Trial
Date
10/09/2012
Condition
Malignant neoplasm of unspecifiedkidney,
except renal pelvis
Subjects at High Risk of Recurrent Renal Cell
Carcinoma
Name Details
Axitinib Dose: 5 mg or 1 mg, Frequency
total duration: twice a day,
Route of Administration: oral,
Duration of Therapy: 3 years
Placebo Dose: 5 mg or 1 mg, Frequency
total duration: twice a day,
Route of Administration: oral,
Duration of Therapy: 3 years
Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
1.Male or female, age more than or equal to 18 years (age more
than or equal to 20 years in Japan). 2.Patients must be
diagnosed utilizing the UISS staging system with one of the
following: a.T2 N0 or Nx, M0, Fuhrman’s grade 3 to 4 (partial
Fuhrman’s grade 3 to 4 is also acceptable) and ECOG PS 0
to1 b.T3 N0 or Nx, M0, any Fuhrman’s grade and ECOG PS 0
to 1 - T3a invasion to Gerota fascia; Tumor more than 4 cm in
greatest dimension is eligible c.T4 N0 or Nx, M0, any
Fuhrman’s grade and ECOG PS 0 to 1 d.Any T, N1, M0, any
Fuhrman’s grade and ECOG PS 0 to 1 3.Patients must have
histologically confirmed preponderant, defined as more than 50%,
clear cell RCC. 4.Patients must have no evidence of
macroscopic residual disease or metastatic disease. 5.Patients
must not have received any previous systemic (includes
chemotherapeutic, hormonal, or immunotherapeutic) treatment for
RCC. 6.Patients must not have received any previous
anti-angiogenic treatment. 7. Patients must have adequate
organ function defined as: Absolute neutrophil count (ANC)
more than or equal to 1500 cells per mm3. Platelets more than
or equal to 75,000 cells per mm3. Hemoglobin (Hgb) more than
or equal to 9.0 g per dL. AST and ALT less than or equal to 2.5
multiplied by upper limit of normal (ULN). Total bilirubin less
than or equal to 1.5 multiplied by ULN. Serum creatinine (Scr)
less than or equal to 1.5 multiplied by ULN or calculated creatinine
clearance (Clcr) more than or equal to 60mL per min by the
Cockcroft-Gault equation, For males; the Cockcroft-Gault equation,
using Scr: Clcr (mL per min) equal to (140 -Age in years) multiplied
by weight (in kilograms) divided by {72 multiplied by Scr (in mg per
page 7 / 10
PDF of Trial
dL)}). The calculated Clcr should be multiplied by 0.85 to adjust
for female gender. •Urinary protein less than 2 by urine
dipstick. If dipstick is more than or equal to 2 then a urine
protein:urine creatinine ratio (UPC) should be done and the patient
may enter only if UPC is less than 2.0. 8.At screening and
Cycle 1 Day 1, no evidence of preexisting uncontrolled hypertension
as documented by 2 blood pressure (BP) readings taken at least 1
hour apart. The systolic blood pressure (sBP) readings must be less
than or equal to 140 mm Hg, and the diastolic blood pressure (dBP)
readings must be less than or equal to 90 mm Hg. Patients whose
hypertension is controlled by antihypertensive therapies are
eligible. 9.Women of childbearing potential and men must use
adequate contraception during the study. Acceptable contraception
for women include implants, injectables, combined oral
contraceptives, intrauterine devices (IUDs), sexual abstinence, or a
partner who has been vasectomized for at least 6 months.
Acceptable contraception for a male includes having had a
vasectomy for at least 6 months, sexual abstinence, or condoms plus
spermicide. 10.Signed and dated informed consent document
(ICD) indicating that the patient (or legally acceptable representative)
has been informed of all pertinent aspects of the trial prior to
enrollment. 11.Willingness and ability to comply with scheduled
visits, treatment plans, laboratory tests, and other study
procedures. 
Exclusion Criteria
Patients presenting with any of the following will not be included in
the trial:
1.Histologically undifferentiated carcinomas, sarcomas, collecting
duct carcinoma, lymphoma, or patients with any metastatic renal
sites.
2.National Cancer Institute (NCI) Common Terminology Criteria for
Adverse Events (CTCAE) Grade 3 hemorrhage less than 4 weeks of
date of randomization.
3.Diagnosis of any second malignancy within the 5 years from date
of randomization, except basal cell carcinoma, squamous cell skin
cancer, or in situ carcinoma of the cervix uteri that has been
adequately treated with no evidence of recurrent disease for 12
months.
4.Any of the following within the 12 months prior to study drug
administration: myocardial infarction, uncontrolled angina,
coronary/peripheral artery bypass graft, symptomatic congestive
heart failure, cerebrovascular accident or transient ischemic attack
and 6 months for deep vein thrombosis or pulmonary embolism.
5.Gastrointestinal abnormalities including:
inability to take oral medication
requirement for intravenous alimentation
prior surgical procedures affecting absorption including total gastric
resection
treatment for active peptic ulcer disease in the past 6 months
active gastrointestinal bleeding, unrelated to cancer, as evidenced by
hematemesis,
hematochezia or melena in the past 3 months without evidence of
resolution
documented by endoscopy or colonoscopy
malabsorption syndromes
6. Current use or anticipated need for treatment with drugs that are
known potent CYP3A4/5 inhibitors (eg, grapefruit juice,
ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir,
nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
7. Current use or anticipated need for treatment with drugs that are
page 8 / 10
PDF of Trial
known CYP3A4/5 or CYP1A2 inducers (eg, rifampin,
dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin,
phenobarbital, and St. John’s wort).
8. Requirement of anticoagulant therapy with oral vitamin K
antagonists. Low-dose warfarin (less than2mg/day) and other
low-dose anticoagulants for maintenance of patency of central
venous access devise or prevention of deep venous thrombosis is
allowed. Therapeutic use of low molecular weight heparin is allowed.
9. Active seizure disorder or evidence of brain metastases, spinal
cord compression, or carcinomatous meningitis.
10. A serious uncontrolled medical disorder or active infection that
would impair their ability to receive study treatment.
11.Known human immunodeficiency virus (HIV) or acquired
immunodeficiency syndrome (AIDS)-related illness.
12.Pregnancy or breastfeeding. All female patients of childbearing
potential must have a negative pregnancy test within the 7 days prior
to date of randomization.
13.Dementia or significantly altered mental status that would prohibit
the understanding or rendering of informed consent and compliance
with the requirements of this protocol.
14.Other severe acute or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with
study participation or study drug administration, or may interfere with
the interpretation of study results, and in the judgment of the
investigator would make the patient inappropriate for entry into this
study.
15.Receipt of any investigational oncology or, approved or
investigational anti-angiogenic agent prior to study entry.
16.Current treatment on another therapeutic clinical trial. Supportive
care trials or non-treatment trials, eg, Patient Reported Outcomes
(PRO) methods studies, are allowed.
me Timepoints
2 years & 5 years
me Timepoints
2 years & 5 years

page 9 / 10
PDF of Trial
blind placebo controlled Phase

daily given up to 3 years vs.
creased depending on
Primary Objective of the study
se free survival (DFS) in
omly assigned to adjuvant
nephrectomy.
page 10 / 10
PDF of Trial
n, 08 Jan 2023 04:58:58 GMT)

wed by Oral Therapy for Hospitalized
ble Dummy, Parallel Group, Comparative

of Ceftazidime Avibactam (CAZ-AVI,
priate Oral Therapy in the Treatment of
elonephritis, With a Gram Negative
Identifier
Protocol Number
ClinicalTrials.gov

Arun Sundriyal
PPD Pharmaceutical Development India Pvt. Ltd., Vatika City Point,
11th Floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon HARYANA
122002 India
Gurgaon
HARYANA
122002
India
911244739903
911244739999
Arun Sundriyal
PPD Pharmaceutical Development India Pvt. Ltd., Vatika City Point,
11th Floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon HARYANA
122002 India
page 1 / 8
PDF of Trial
Gurgaon
HARYANA
122002
India
911244739903
911244739999

AstraZeneca AB
S-151 85, Sodertalje, Sweden
Address
NIL
ollo Hospitals Oncology Day Care- 919448011263

Basement, 154/11, Opp 918026304017
IIM, Bannerghatta deepakbolbandi@gmail
Road, Bangalore - .com
560076, Karnataka,
India
Bangalore
KARNATAKA
ollo Hospitals AHERF- Clinical trail 00919848031831

terprise Limited Unit, 1st Floor, AIMSR 00914023543270
Building Apollo Health raja_urol@rediffmail.co
City, Jubilee Hills, m
page 2 / 8
PDF of Trial
Hyderabad – 500096,
Hyderabad
ANDHRA PRADESH
re Institute of Care Institute of 00919099068938
edical Sciences Medical Sciences 00917927712777
MS) Hospital Private (CIMS) Hospital Private drbhagyeshshah@gmai
mited Limited, Near Shukan l.com
Mall, Off Science City
Road, Sola,
Ahmedabad-380060,
Gujarat, India
Gandhinagar
GUJARAT
enanath Mangeshkar Urology Department, 9822040813

spital and Research C-6, C-Wing, 0202467060
ntre Erandwane – 411004, jaydeepdate@gmail.co
India m
Pune
MAHARASHTRA
Department of medicine Department of 00911512226334
medicine, PBM (AG) 00911512201119
Hospital, S. P. Medical drskkochar@rediffmail.
College, com
Bikaner-334003,
Rajasthan, India
Bikaner
RAJASTHAN
hangir Clinical Ground Floor, Jehangir 919822049385

velopment Centre Hospital Premises, 32 91202612255
t Ltd Sasoon Road, Pune – drsmambike@yahoo.co
422001, Maharashtra, .in
India
Pune
MAHARASHTRA
sturba Medical Dept of Urology and 919008002440

llege and Hospital Renal Transplant, 918202571934
Room No 14, 1st Floor urologyarun@yahoo.co
Manipal-576104, m
Karnataka, India
Udupi
KARNATAKA
ar Hospitals (Unimed Department of 9963884644

alth Care Pvt. Ltd.) Nephrology, 8-2-596/5, 04023356788
Road No. 10, Banjara jyothsna@yahoo.com
Hills,
Hyderabad-500034,
AP, India
Hyderabad
ANDHRA PRADESH
erling Hospital Clinical Research 917940011622

Department, 2nd Floor, 917926466700
Sterling Hospital Road, pkandarp@hotmail.com
Memnagar,
Ahmedabad – 380052,
Gujarat, India
Ahmadabad
GUJARAT
page 3 / 8
PDF of Trial
Committee?

view
Date
28/01/2014
Condition
Complicated Urinary Tract Infection (cUTI)
Including Acute Pyelonephritis.
Urinary tract infection, site notspecified
Name Details
Drug 1: CAZ-AVI Drug 2: Patients are randomized to
Doripenem either CAZ-AVI or Doripenem
as active treatment. Both
CAZ-AVI and Doripenem are
given via IV infusion every 8
hours. Total duration is 10 days
(3 doses per day) or up to 14
days if the patient is
bacteremic.Dosage:(CAZ-AVI
ceftazidime avibactam;
Doripenem).
Drug 1: Ciprofloxacin Drug 2: The protocol also allows
Sulfamethoxazole/ trimethoprim subjects to switch to oral
therapy (which would be the
Ciprofloxacin or the
Sulfamethoxazole/trimethoprim)
. The option to switch can occur
at any time point after the
subject has completed a
minimum of 5 full days of IV
page 4 / 8
PDF of Trial
dosing (15 doses since there

are 3 doses per day). Once
subjects switch to oral, the
frequency is twice per day. Total
duration of oral therapy will
depend on what day the subject
was switched to oral therapy
and whether the subject was
bacteremic at study entry to
know if subject will complete 10
or 14 days’ worth of
therapy.Dosage:( Ciprofloxacin;
Sulfamethoxazole/trimethoprim)
.
Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
18 to 65 years of age inclusive. Female patients can
participate if they are surgically sterile or completed menopause or
females capable of having children and agree not to attempt
pregnancy while receiving IV study therapy and for a period of 28
days after. Has pyuria with greather than or equal 10
WBCs and has a positive urine culture within 48 hours of enrollment
containing greather than or equal 10 to the fifth CFU/ml of a
recognized uropathogen known to be susceptible to IV study therapy
(CAZ-AVI and doripenem). Demonstrates either acute
pyelonephritis or complicated lower UTI without pyelonephritis. 
Exclusion Criteria
Urine pathogen is a Gram-positive pathogen or a uropathogen
resistant to CAZ-AVI or doripenem.
Patient urine culture at study entry isolates more than 2
microorganisms regardless of colony count or patient has a
confirmed fungal UTI.
Patient is receiving hemodialysis or peritoneal dialysis or had a renal
transplant.
Patient is immunocompromised.
Patient is considered unlikely to survive the 6- to 8-week study
period or has a rapidly progressive or terminal illness.
me Timepoints
1.Day 5 after study drug start.
2.21 to 25 day after randomization.
page 5 / 8
PDF of Trial
me Timepoints
Within 24 hours after IV (intravenous)
completion, 21 to 25 days and 45 to 52 days
after study drug start.

21 to 25 days and 45 to 52 days after study drug
start.


completion,anytime between 21 - 25 days and
anytime between 45 - 52 days after the start of
the study drug.


24 hours after completion of study drug, 21 to 25

days and 45 to 52 days after the start of the
study drug.
21 to 25 days after study drug start.
page 6 / 8
PDF of Trial
to 25 days after study drug start.
y 5 and 21 to 25 days after study drug start.
y time after start of study drug to end of IV

travenous) study therapy, which is a minimum
5 days to a maximum of 14 days of IV study
erapy.

erapy.

erapy.

erapy.
ytime within 15 minutes prior to or after

pping study drug, anytime between 30 and 90
nutes after stopping study drug, anytime
tween 300 minutes and 360 minutes after
pping study drug.
pping study drug, anytime between 30 and 90
nutes after stopping study drug, anytime
tween 300 minutes and 360 minutes after
pping study drug.
page 7 / 8
PDF of Trial
stopping study drug, anytime between 30 and 90

minutes after stopping study drug, anytime
between 300 minutes and 360 minutes after
Anytime within 15 minutes prior to or after

stopping study drug, anytime between 30 and 90
minutes after stopping study drug, anytime
between 300 minutes and 360 minutes after

tazidime Avibactam compared to

ated urinary tract infections, including
page 8 / 8
PDF of Trial
n, 08 Jan 2023 04:59:09 GMT)
d after surgery,between the two

VS TRANSPERITONEAL APPROACH,in
ors.
ritoneoscopic vs transperitoneal
a-A Randomized controlled trial
Identifier
Other
DR VENUGOPAL G
PROFESSOR
GOVT MEDICAL COLLEGE,THIRUVANANTHAPURAM
Dr. G. VENUGOPAL UTHRADOM KOCHULLOOR, MEDICAL
COLLEGE POST PROFESSOR DEPT. OF UROLOGY SUPER
SPECIALITY BLOCK GOVT MEDICAL COLLEGE
Thiruvananthapuram
KERALA
695011
India
09447055070
drgvenugopal@yahoo.co.in
DR NAVIN CHRISTOPHER A
senior resident
govt medical college,Thiruvananthapuram
Gurukripa kesava gardens, murinjapalam medical college post
senior resident dept. of urology super speciality block govt medical
college
Thiruvananthapuram
KERALA
695011
India
09895552073
navinchristopher.angus@gmail.com
DR NAVIN CHRISTOPHER A
senior resident
govt medical college,Thiruvananthapuram
2/1120(9),gurukripa kesava gardens, murinjapalam medical college
post senior resident dept. of urology super speciality block govt
medical college thiruvananthapuram-695011
Thiruvananthapuram
page 1 / 4
PDF of Trial
KERALA
695011
India
09895552073
navinchristopher.angus@gmail.com
EDICAL COLLEGE HOSPITAL,

DR G VENUGOPAL
PROFESSOR, DEPT. OF UROLOGY, SUPER SPECIALITY
BLOCK, GOVT. MEDICAL COLLEGE,
THIRUVANANTHAPURAM-695011
Other [PRINCIPAL INVESTIGATORS INITIATIVE]
Address
SENIOR RESIDENT, DEPT. OF UROLOGY,
SUPERSPECIALITY BLOCK, GOVT. MEDICAL
COLLEGE,THIRUVANANTHAPURAM-695011
OVT. MEDICAL UROLOGY 2 OPD 09447055070

OLLEGE HOSPITAL SUPER SPECIALITY drgvenugopal@yahoo.c
BLOCK o.in
Thiruvananthapuram
KERALA

Committee?
Date
No Date Specified
Condition
RENAL CELL CARCINOMA
Name Details
Retroperitoneoscopic radical laparoscopic radical
nephrectomy nephrectomy done through the
retroperitoneal route in renal cell
carcinoma patients.Patients are
randomly assigned this surgery.
Transperitoneal laparoscopic Laparoscopic radical

radical nephrectomy neprectomy through the
transperitoneal route done in
patients with renal cell
carcinoma.Patients are
randomly assigned this surgery.
page 2 / 4
PDF of Trial
Inclusion Criteria
13.00 Year(s)
80.00 Year(s)
Both
All participants of age > 12 years, admitted in Medical College
Hospital, Thiruvananthapuram with a Computerized Tomography
(CT) evidence of Renal Tumor with stage CT1, T2 who are willing to
give consent to participate.
Exclusion Criteria
History of prior major abdominal surgery in the quadrant of interest.
BMI greater than 35
me Timepoints
6 months
me Timepoints
6 months

, single tertiary care centre study
copic vs transperitoneal laparoscopic
noma. Study conducted in Govt. Medical
e size 40, 20 in each arm. Expected
page 3 / 4
PDF of Trial
post operative analgesia requirement between
ive complications between the two laparoscopic

page 4 / 4
PDF of Trial
n, 08 Jan 2023 04:59:16 GMT)
n® Tablet (Continus® Controlled release

ment of Lower Urinary Tract Symptoms
Routine Clinical Practice
d Efficacy of Once-Daily Tamcontin®
n Hydrochloride, 0.4 mg) in the Treatment
Prostatic Hyperplasia (BPH) in the Routine
Identifier
Protocol Number
Dr Harbans Singh
Chief Urologist
R. G. Urology and Laparoscopy Hospital
R. G. Urology and Laparoscopy Hospital 194-195, Deepali Chowk,
Pitampura, Delhi
North West
DELHI
110034
India
harbanspruthi@hotmail.com
Dr Harbans Singh
Chief Urologist
Pitampura, Delhi
DELHI
110034
India
Dr Harbans Singh
Chief Urologist
Pitampura, Delhi
DELHI
page 1 / 4
PDF of Trial
110034
India

ModiMundiPharma Pvt Ltd
Umesh Modi Group, Modi Tower, 98, Nehru Place, New Delhi –
110019 (India)
Address
Not Applicable
ble Medicare Noble Medicare 01125614743

C2B/62A Janakpuri drdinesh@yahoo.com
New Delhi 110058
West
DELHI
G. Urology and R. G. Urology and 01147571000
paroscopy Hospital Laparoscopy Hospital harbanspruthi@hotmail.
194-195, Deepali com
Chowk, Pitampura
North West
DELHI

paroscopy Hospital Laparoscopy Hospital info@rghospital.com
F-12, Easy of Kailash,
New Delhi 110065
South
DELHI

paroscopy Hospital Laparoscopy Hospital drpwadhwa@gmail.com
B-1, Vishal Enclave,
opp. police Station,
Rajouri Garden , New
Delhi 110027
West
DELHI
ma Nursing Home Sama Nursing Home 9868163172

Sadiq Nagar, 8 Siri Fort rajiba_nayak@rediffmai
Road New Delhi l.com
110049
South
DELHI
ology Clinic Urology Clinic, 01127519006

135/F-22, Rohini Sector akgsurbhi@yahoo.co.in
3, Delhi 110085
North
DELHI
page 2 / 4
PDF of Trial
ology Clinic Clinic 8/29. East Patel 01125826060

Nagar, New Delhi sk1975@gmail.com
110008
West
DELHI

Committee?
Date
No Date Specified
Condition
Condition
Condition: Benign Prostate Hyperplasia (BPH);
Trial Participant: Newly diagnosed, treatment
naive BPH patients eligible to receive
Tamsulosin hydrochloride, 0.4 mg in the routine
clinical practice
Name Details
Tamcontin® tablet Tamcontin® tablet (Continus®
controlled release tablet of
Tamsulosin hydrochloride, 0.4
mg)once a day for 6 weeks.
Not Applicable Not Applicable
Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Male
Newly diagnosed, treatment naive BPH patients eligible to receive
Tamsulosin hydrochloride, 0.4 mg in the routine clinical practice
Exclusion Criteria
Not Applicable
me Timepoints
Patient Visits: Visit 1 (Day 0); Visit 2 (Week 3);
and Visit 3 (Week 6)
me Timepoints
Not Applicable

page 3 / 4
PDF of Trial
a on the safety and efficacy of Tamcontin®
ipharma Pvt. Ltd. in the routine clinical
ies of the product have shown that a high
let is dosed at 9 pm while also maintaining
time-period. This may be due to
n turn could lead to a better management
ajor clinical problem faced by BPH
ts of BA/BE studies with the clinical
page 4 / 4
PDF of Trial
n, 08 Jan 2023 04:59:28 GMT)
abolism of a Solifenacin Liquid Suspension
or Overactivity
Sequential Dose Titration Study to Assess
netics of Solifenacin Succinate Suspension
ogenic Detrusor Overactivity (NDO)
Identifier
EudraCT
Protocol Number
ClinicalTrials.gov

Arun Sundriyal
Associate Director-Clinical Management
PPD Pharmaceutical Development India Private Limited
PPD Pharmaceutical Development India Private Limited, Vatika City
Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road
Gurgaon
HARYANA
122002
India
911244739903
911244739999
arun.sundriyal@ppdi.com
Arun Sundriyal
Associate Director-Clinical Management
PPD Pharmaceutical Development India Private Limited
PPD Pharmaceutical Development India Private Limited, Vatika City
Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road
Gurgaon
HARYANA
122002
page 1 / 5
PDF of Trial
India
911244739903
911244739999
arun.sundriyal@ppdi.com
Leiden,The Netherlands
Astellas Pharma Europe BV
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden,The
Netherlands
Address
01-Dynasty B-Wing (Kanakia Spaces),Andheri-
Kurla Road, Andheri East, Mumbai-400059.
India

dyline Hospitals Nava Vikas Gruh Road, 919824035673
Opp Annapurna Hall, shaileshshahuro@yaho
Nr. Dev Status, Paldi – o.com
380007
Ahmadabad
GUJARAT
Ram Manohar Lohia Room no. 31, OPD 919810005182

spital & PGIMER Block, Baba Kharag drsoodr@yahoo.com
Singh Marg-110001
New Delhi
DELHI
malayan Institute of Department of 919837263544

edical Sciences Urology,HIHT lalshobha@gmail.com
University, Swami Ram
Nagar,
P.O.-Doiwala-248140
Dehradun
UTTARANCHAL
page 2 / 5
PDF of Trial
amdar Multispeciality Hospital Building S. No. 919822059799

spital 15, Department of 912030502275
Surgery, Fatima Nagar, rajendrakshimpi@gmail
Near KPCT Mall- .com
411040
Pune
MAHARASHTRA

Committee?

view
bmittted/Under No Date Specified Yes
view
Date
07/12/2012
Condition
Neurogenic Detrusor Overactivity
Name Details
Solifenacin succinate Oral Doses will be calculated
suspension 1 mg per mL (100 according to weight, in ranges,
mL) targeting equivalent exposure to
the 2.5, 5, 7.5 and 10 mg doses
once daily in adults at steady
state. Oral administration (via
syringes) in the morning, with a
glass of water afterwards.
Duration of treatment-52 weeks
Open Label Trial-NA Open Label Trial-NA

Inclusion Criteria
5.00 Year(s)
17.00 Year(s)
Both
Documented diagnosis of NDO, confirmed by urodynamics. 
Practicing clean intermittent catheterization (CIC). Currently on
treatment with an antimuscarinic drug. 
Exclusion Criteria
Known genitourinary condition (other than NDO) that may cause
incontinence.
Bladder augmentation surgery.
Current Faecal impaction.
page 3 / 5
PDF of Trial
Electro-stimulation therapy within 2 weeks prior to screening and at
any time during the study.
Subjects with the following gastro-intestinal problems: partial or
complete obstruction, decreased motility like paralytic ileus, subjects
at risk of gastric retention.
Reflux grade 3 or 4.
Current urinary tract infection (UTI).
Subject has severe renal impairment (glomerular filtration rate less
than 30 ml/min).
Subject has severe hepatic impairment (Child-Pugh score greater
than 9).
Subject has received intra-vesical botulinum toxin within 9 months
prior to screening.
me Timepoints
me Timepoints
Baseline, Week 9, Week 24 and Week 52
Week 9, Week 24 and Week 52
Baseline, Week 3 to Week 52
Baseline, Week 24 and Week 52

page 4 / 5
PDF of Trial
the treatment of symptoms and

n children and adolescents. NDO often
amage where the bladder muscle contracts
e an inability to void, so that catheterization
cin succinate. Solifenacin tablets are given

quid suspension has been developed to
be investigated. The take-up and length of

also be investigated during this study.
ompleting patients will receive 52 weeks of
g and emptying of the bladder) and urine

he diary responses relating to the number
ne, review of the ECG, ultrasound of the

e function) and the ability to see near and
dia.
the treatment of symptoms and
n children and adolescents. NDO often
amage where the bladder muscle contracts
e an inability to void, so that catheterization
cin succinate. Solifenacin tablets are given

quid suspension has been developed to
be investigated. The take-up and length of

also be investigated during this study.
ompleting patients will receive 52 weeks of
g and emptying of the bladder) and urine

he diary responses relating to the number
ne, review of the ECG, ultrasound of the

e function) and the ability to see near and
dia.
page 5 / 5
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Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:53:11 G

CTRI Number CTRI/2011/08/001935 [Registered on: 02/08/2011] - Trial Registered Prospectively

Secondary IDs if Any Secondary ID

Details of Secondary Name

Countries of List of Countries

Sites of Study Name of Principal Name of Site

Dr Chandrashekhar Brain and Mind

Dr Mohit Bhatt Kokilaben Dhirubhai

Dr Vijayan Krishnan Kovai Medical Center

Dr Rangashetty M S Ramaiah Medical

Dr Puneet Agarwal Max Super Speciality

Dr Uday Muthane Parkinson’s & Ageing

Dr Asha Kishore Sree Chitra Tirunal

Dr Suresh Kumar Vijaya Health Centre

Details of Ethics Name of Committee Approval Status

KMCH Ethics Submittted/Under

Regulatory Clearance Status

Health Condition / Health Type

must have been on a stable regimen of<br/> treatment for at least

months of Screening; poorly controlled diabetes; abnormal renal

- Must not have an untreated major depressive disorder meeting

- Must not have failed to show a therapeutic response if a diagnostic

- Must not be at imminent risk of self-harm or harm to others.

- Must not have elevated blood pressure (BP) (systolic BP greater

- Must not have had any clinically significant cardiovascular event or

- Must not have an alanine aminotransferase (ALT) or aspartate

- Must not have active serologically-confirmed hepatic dysfunction

- Must not have a history within the past 5 years of a primary or

- Must not have received certain prespecified medications or

- Must not have an average daily consumption of more than three 4

- Must not have a severe or ongoing unstable medical condition (eg,

- Must not have alle

Method of Generating Computer generated randomization

Secondary Outcome Outcome

Target Sample Size Total Sample Size=1000

Phase of Trial Phase 3

Recruitment Status of Other (Terminated)

Details of Secondary Name

Countries of List of Countries

United States of America

Sites of Study Name of Principal Name of Site

Dr Angamuthu Meena Nizam Institute of

Dr Uday Muthane Parkinson’s & Ageing

Dr Asha Kishore Sree Chitra Tirunal

Dr Sarma St. Johns Medical

Dr Suresh Kumar Vijaya Health Centre

Details of Ethics Name of Committee Approval Status

Site 3: Institutional Approved

Regulatory Clearance Status

Method of Generating Computer generated randomization

Secondary Outcome Outcome

Target Sample Size Total Sample Size=750

Phase of Trial Phase 3

Recruitment Status of Other (Terminated)

Preladenant in Subjects With Moderate to Severe Parkinson’s Disease

Number of Trial Centers: Approximately 163 sites.

Duration of Participation: Each subject will participate for approximately 42 weeks

weeks of active treatment followed by a 2-week Safety Follow-Up Visit).

Preladenant is a tablet. Rasagiline will be supplied as a capsule. A placebo tablet matc

Details of Secondary Name

Sites of Study Name of Principal Name of Site

Details of Ethics Name of Committee Approval Status

Regulatory Clearance Status