Example 001 51 Merged

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:47:04
CTRI Number CTRI/2010/091/000096 [Registered on: 05/03/2010] -

Last Modified On 07/01/2015
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study A Clinical Study to determine the efficacy and safety of Inj Diclofenac 75mg/mL given a
injection versus Diclofenac 75mg/3mL given as an IV infusion in the management of po
pain
Scientific Title of A Randomized, Parallel Group, Comparative Study Evaluating the Efficacy and Tolera
Study Injection Diclofenac Sodium 75mg/1mL given as an IV Injection versus Diclofenac Sod
75mg/3mL given as an Infusion in the management of Post Operative Pain.
Secondary IDs if Any Secondary ID

CT/04/05
Details of Principal
Investigator or overall Name Dr Sanjay Maroo
Trial Coordinator
Designation General Manager
(multi-center study)
Affiliation Troikaa Pharmace
Address Medical Services
Commerce House
Ahmadabad
GUJARAT
380 054
India
Phone 07926856242
Fax 079-26856246
Email sanjaymaroo@tro
Details Contact De
Person (Scientific Name Dr Sanjay maroo
Query)
Commerce House
Ahmadabad
GUJARAT
380 054
India
Phone 07926856242
Fax 07926856246
Details Contact D
D
Person (Public Query) Name Dr sanjay maroo
Commerce House
Ahmadabad
GUJARAT
380 054
India
Phone 07926856242
Fax 07926856246
Source of Monetary or So
Material Support > Troikaa Pharmaceuticals Limited
Primary Sponsor
Name Troikaa Pharmace
Address Commerce House
Bodakdev Ahmed
Type of Sponsor Pharmaceutical in
Details of Secondary Name

Sponsor Nil
Countries of List of Countries
Recruitment India
Sites of Study Name of Principal Name of Site

Investigator
Dr. Jaishree Bogra Chhatrapati Shahuji
Maharaj Medical
University, U. P.
Col T V S P Murthy Command Hospital

(CC)
Dr. Shubha Mohite Dr. D. Y. Patil Medical
College
Dr. P. N. Kakar Fortis Hospital
Dr. B. M. Subnis Padmashree Dr. D. Y.

Patil Medical College
Dr Anil Varshney R G Stone Urology &

Laparoscopy Hospital
Dr. Prerana Shroff Seth GS M

College & KE
Details of Ethics Name of Committee Approval Status

Committee
Independent Ethics Approved
Committee - Aditya
Committee - aditya-
Ahemdabad
Committee- Aditya
Ahmedabad
Institutional Ethics Approved
committe, Dr. D. Y. Patil
Medical College, Navi
Mumbai
committe, Padmashree
Dr. D. Y. Patil Medical
College, Pune

Committee for
Research on Human
Subjects - Seth GS
Medical College & KEM
Hospital, Mumbai
Institutuional Ethics Approved

Committee of C. S. M.
Medical University,
Lucknow
Regulatory Clearance Status

Status from DCGI Approved/Obtained
Health Condition / Health Type

Problems Studied Patients
Intervention / Type
Comparator Agent Intervention
Comparator Agent
Inclusion Criteria
Age From 18.00 Year(s)
Age To 60.00 Year(s)
Gender Both
Details 1Patients in the ag
sexes 3Patie
moderate to sever
pain at baseline (V
Exclusion Criteria
Details 1. Patients below
2. Patients with co
3. Pregnant and la
4. Patients with hi
bronchitis
5. Patients with co
6. Mentally retarde
7. Unwilling patien
8. Patients with kn
diclofenac sodium
the study formulat
9. Patients with m
Method of Generating Computer generated randomization

Random Sequence
Method of An Open list of random numbers
Concealment
Blinding/Masking Participant and Outcome Assessor Blinded
Primary Outcome Outcome
1. Time to onset of analgesia
2. Intensity of Post Operative Pain as assessed
by Visual Analogue Scale (VAS)
Secondary Outcome Outcome

Percentage Pain Relief
Global efficacy by Patient and Investigator
Degree of Pain Relief as assessed on a 5- point
Pain Relief Rating Scale
Pain and Evidence of Thromboplebitis at the site
of Injection/ Infusion
Systemic Adverse Events
Target Sample Size Total Sample Size=250

Sample Size from India=250
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=
Phase of Trial Phase 3

Date of First 03/04/2010
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=0
Days=0
Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Results of the study is published in international journal of pharmaceutical sciences an
same is available at below link; http://www.ijpsr.com/V4I12/36%20Vol.%204,%20Issue
December%202013,%20IJPSR-2865,%20Paper%2036.pdf
One of the most commonly used NSAID for postoperative pain is diclofenac. Diclofena
currently available as a 3 ml formulation (75 mg/ 3 ml). A novel formulation of diclofena
developed which dissolves 75 mg of diclofenac in just 1 ml of the solvent. The aim of th
compare the efficacy and safety of IV administration of the 1 ml diclofenac formulation
Brief Summary One of the most commonly used NSAID for postoperative pain is diclofenac. Diclofena
currently available as a 3 ml formulation (75 mg/ 3 ml). A novel formulation of diclofena
developed which dissolves 75 mg of diclofenac in just 1 ml of the solvent. The aim of th
compare the efficacy and safety of IV administration of the 1 ml diclofenac formulation
ml formulation given as IV infusion in the management of post operative pain.


Type of Study Biological
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder
Scientific Title of A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study Eva
Study Efficacy And Safety Of Tanezumab For The Treatment Of Moderate To Severe Pain A
With Interstitial Cystitis/ Painful Bladder Syndrome (IC/PBS)

A4091035
NCT00999518
Investigator or overall Name Swapnali Raut
Trial Coordinator
Designation Compliance Overs
Affiliation Representing Pfiz
Address Pfizer Limited, Pa
Mumbai, MAHARA
Floor, Platina, Plo
Bandra (E), Mumb
Mumbai
MAHARASHTRA
400 102
India
Phone 91-9821415224
Fax 91-022-26525993
Email Swapnali.raut@pf
Details Contact De
Person (Scientific Name Swapnali Raut
Query)
Mumbai, MAHARA
Floor, Platina, Plo
Bandra (E), Mumb
Mumbai
MAHARASHTRA
400 102
India
Phone 91-9821415224
Fax 91-022-26525993
Details Contact D
Person (Public Query) Name Swapnali Raut
Mumbai, MAHARA
Floor, Platina, Plo
Bandra (E), Mumb
Mumbai
MAHARASHTRA
400 102
India
Phone 91-9821415224
Fax 91-022-26525993
Material Support > Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 40
Primary Sponsor
Name Pfizer Limited
Address Pfizer Centre, Pat
400 102, India

Sponsor nil
Recruitment Belgium
Canada
Finland
Japan
Other
Poland
Republic of Korea
Romania
Russian Federation
Slovakia
Spain
Sweden
Taiwan
United States of America

Investigator
Dr. Nagendranath Kidney and Urology
Mishra Hospital,Interstitial
Cystitis Center
Dr. Kandarp Parikh Sterling Hospital Road,

Committee
IEC Consultants, Approved
Darussalam
Sterling Hospitals Approved

Ethics Committee
Intervention / Type
Intervention
Intervention
Intervention
Intervention
Comparator Agent
Inclusion Criteria
Gender Both
Details Ages Eligible for S
Study:Both, A
with interstitial cys
months with mode
greater than 7 per
oral medicines for
least 3 months. O
(there is no upper
Exclusion Criteria
Details 1. Patients on cert
bladder syndrome
2. Body mass inde
3.History of allergi
diagnostic monocl
4. Patients with pe
5. Patients with Ty
HbA1c graeter tha

Random Sequence
Method of Centralized
Concealment
Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
The primary endpoint is change from Baseline in
mean average daily pain over 7 days at Week 16
as measured by an 11-point Numeric Rating
Scale (NRS).
Change from Baseline in mean average daily
pain over 7 days at other time points throughout
the study as measured by an 11-point Numeric
Rating Scale (NRS)
Treatment Response: Reduction of greater than

equal to 30% and greater than equal to 50% in
mean average daily pain score from Baseline at
various time points through the study
Change from Baseline in mean worst daily pain

over 7 days as measured by an 11-point
Numeric Rating Scale (NRS)
Patient Global Assessment
Global Response Assessment
Micturition frequency per 24 hours, including
nocturnal frequency
Micturition urgency frequency per 24 hours
Urge to urinate
Mean volume voided per micturition
O'Leary-Sant Interstitial Cystitis Symptom Index
(ICSI) score
Brief Pain Inventory (BPI)
Patient Reported Treatment Impact (PRTI)
EQ5D questionnaire
Painful Bladder/Interstitial Cystitis Quality of Life
Questionnaire (PBIC-QoL)
Rescue medication use
Biomarkers for Interstitial Cystitis/Painful bladder
syndrome
Physical examination, including SC injection site.
Neurological examination and Neuropathy
Impairment Score (NIS).
Vital signs (temperature, blood pressure, heart
rate and respiratory rate).
Weight.
ECG
Post void residum (PVR) volume assessment
using trans-abdominal ultrasound
Pregnancy testing, Urinalysis, Clinical laboratory
assessments, Anti-Drug Antibody (ADA;
anti-bodies against tanezumab), Adverse events
from time of Screening through the last clinic visit

Final Enrollment numbers achieved (Total)=Applicable only for Completed/Termina
Final Enrollment numbers achieved (India)=Applicable only for Completed/Termina
Total Sample Size=360

Enrollment (India)
Enrollment (Global)
Trial Months=8
Days=0
Recruitment Status of Other (Terminated)
Trial (Global)
Trial (India)
Publication Details NONE
Brief Summary This study was terminated on 16 November 2010 following a US FDA partial clinical ho
tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential sa
and following a pre-planned interim analysis.
No subjects were enrolled in India in this trial.

Type of Study Drug
Public Title of Study A comparative clinical study to evaluate efficacy and safety of fixed dose combination o
+ Sulbactam (CSE 1034) vs Ceftriaxone in patients suffering from various bacterial infe
Scientific Title of An open labeled, randomized, comparative study to evaluate efficacy and safety of fixe
Study combination of Ceftriaxone + Sulbactam (CSE-1034) vs Ceftriaxone in subjects sufferi
various bacterial infections.

CSE 1034- Cef/2009
Investigator or overall Name Dr Mahip Saluja
Trial Coordinator
Designation
Affiliation
Address Associate Profess
medical college M
Meerut
UTTAR PRADESH
250001
India
Phone 09837360657
Fax
Email drmahip@hotmail
Details Contact De
Person (Scientific Name Mr Pankaj
Query)
Designation
Affiliation Venus Clinical Re
Address Venus Remedies
EPIP Phase-I Exte
Pradesh Venus R
Area Panchkula
Solan
HIMACHAL PRAD
173 205
India
Phone 01795302024
Fax
Email cra@venusremed
Details Contact D
Person (Public Query) Name Mr Pankaj
Name Mr Pankaj
Designation
Affiliation
Address Venus Remedies
E.P.I.P., Phase-I,
Pradesh Venus R
Area, Panchkula
Solan
HIMACHAL PRAD
173 205
India
Phone 01795302019
Fax
Email cra@venusremed
Material Support > Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri, E.P.I.P., Phase-I,
Village Bhatoli Kalan Baddi, Himachal Pradesh Pin code: 173 205, India
Primary Sponsor
Name Venus Remedies
Address Hill Top Industrial
(Extension) Village
173 205, India

Sponsor Nil
Recruitment India
Investigator
Dr. S.R Lakshmipathy #BA-58,K.H.B.
Quarters, Kavalabyaras
andra,R.T.Nagar,
Banglore-32
Dr. Kumara Swamy Basauangudi ENT Care

Centre
Dr. Ajay dande Dande Diabetes and
health Care Center
Maternity and Nursing
Home
Dr. Kilash. N Dr. B.R. Ambedkar

Medical
College/Hospital
Dr. Gurdeep singh Dr. Gurdeep singh,

Senior orthopedic
surgeon
Dr. S.P yadav Dr. S.P yadav,

Deaprtment of urology
Dr. Shriram Kulkarni Kharghar Diabetes and

Heart Care Center
Dr Sudhir Rathi LLRM Medical College

& Hospital Meerut
Dr. Sandeep Kumar M.V. Hospital &

Gupta Research Center
Dr. Ashish Makkar Makkar Medical Center

Dr. Deepak Bhambe Narendra Prakash
Health Care Center
Dr. Sapna Verma Ramakrishna Medical

center Mother and Child
Clinic
Dr. Umakanth Patil S.S. Institute of Medical
Science & Research
Centre
Dr Lalit Kaushal Saket Hospital
Dr Mahip Saluja Subarti Medical

College, Merrut (U.P.),
India

Committee
Committee (I.E.C)
L.L.R.M, Medical
College & Hospital,
Meerut (U.P.), India

Committee
(I.E.C)S.M.S.(Sawai
Man Singh),Medical
College & Hospital

Committee, Subarti
Medical College,
Meerut
North Zone Approved
Independent Ethics
Committee
Status
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details Male and female s
Clinically diagnose
skin structure infe
Surgical prophylax
Meningitis,LRTI(L
willing to give writt
patients ready to g
Exclusion Criteria
Details History of hyperse
pencillin group of
sulbactam. Presen
loss Pregnant and

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Not Applicable
To evaluate the efficacy of fixed dose
combination of Ceftriaxone + sulbactam +
non-antibiotic
adjuvant EDTA (CSE 1034) as compared to
monotherapy of Ceftriaxone in subjects suffering
from different
bacterial infections.

to establish safety of CSE 1034 vs ceftraioxne


24/02/2010
Enrollment (India)

Enrollment (Global)
Trial Months=9
Days=0

Trial (Global)
Trial (India)
Publication Details NA
Brief Summary The study is open labeled, randomized, two arm trial to evaluate efficacy and safety of
comparison with ceftriaxone in patients suffering from various bacterial infections.Prim
measures will be clinical and bacteriological efficacy evaluations. i.e. Number of patien
completion of treatment, Average time taken for cure, Number of pathogens isolated o
of treatment. Secondary Outcome shall measure safety of the study drugs.
Last Modified On
Post Graduate Thesis
Type of Trial
Type of Study
Study Design Other
Public Title of Study RISK OF SEIZURE RECURRENCE IN PATIENTS WITH NEW ONSET PARTIAL SEIZ
COMPARATIVE STUDY BETWEEN PATIENTS HAVING SOLITARY CYSTICERCUS
GRANULOMA AND THOSE WITH NORMAL NEUROIMAGING
Scientific Title of RISK OF SEIZURE RECURRENCE IN PATIENTS WITH NEW ONSET PARTIAL SEIZ
Study COMPARATIVE STUDY BETWEEN PATIENTS HAVING SOLITARY CYSTICERCUS
GRANULOMA AND THOSE WITH NORMAL NEUROIMAGING

NIL
Investigator or overall Name Dr Pawan Sharma
Trial Coordinator
Designation
Affiliation
Address department of neu
Lucknow
UTTAR PRADESH
226003
India
Phone 05222257090
Fax 05222257090
Email drpawan_sharma@
Details Contact De
Person (Scientific Name prof R.K.GARG
Query)
Designation
Affiliation
Address department of neu
Lucknow
UTTAR PRADESH
226003
India
Phone 05222257090
Fax 05222257090
Email garg50@yahoo.co
Details Contact D
Person (Public Query) Name prof R.K.GARG
Designation
Affiliation
Address Department of neu
Lucknow
UTTAR PRADESH
226003
India
Phone 05222257090
Fax 05222257090
Email garg50@yahoo.co
Material Support > none
> none
Primary Sponsor
Name none
Address
Type of Sponsor

Sponsor none
Recruitment India
Investigator
Prof R.K GARG Department of
neurology

Committee
INSTITUTIONAL Approved
ETHICS COMMITTEE,
CSMMU,LUCKNOW

Status from DCGI Not Applicable
Problems Studied
Type
Intervention / Type
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details The patients of ne
CECT brain show
neuroimaging incl
Exclusion Criteria
Details the patientswho h
albendazole or ste
syndrome such as
Method of Generating Not Applicable

Random Sequence
Concealment

seizure recurrence

death

Sample Size from India=
Phase of Trial N/A

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

Trial (Global)
Recruitment Status of
Trial (India)
Publication Details
Brief Summary this is a prospective observational study of patients with new onset partial seizures.the
having lesion fulfilling criteria of SCG (as defined by Rajshekhar et al) in CECT Brain a
having normal neuroimaging (both CECT as well as MRI with GAD)will be followed for
recurrence for atleast 6 months.the risk of seizure recurrence will be compared in both
and predictors of seizure recurrence will be evaluated.

Last Modified On
Type of Trial
Type of Study
Study Design Single Arm Study
Public Title of Study A clinical trial to study the effects of Inj SUDOPEN (Doripenem 500 mg dry powder for
patients with moderate to severe infections.
Scientific Title of Safety, Tolerability and Efficacy of Inj SUDOPEN in the treatment of Moderate to Seve
Study
NIL
Investigator or overall Name Monika Obrah
Trial Coordinator
Designation
Affiliation
Address Project Leader, M
No.77-B, Sector-1
Gurgaon
HARYANA
122015
India
Phone +9112441900-411
Fax +911244016855
Email monika.obrah@ra
Details Contact De
Person (Scientific Name Dr. Anudeep Sand
Query)
Designation
Affiliation
Address Medical Monitor, M
No.77-B, Sector-1
Gurgaon
HARYANA
122015
India
Phone +911244194395
Fax +911244016855
Email Anudeep.sandhu@
Details Contact D
Person (Public Query) Name Monika Obrah
Designation
Affiliation
Address Project Leader, M
No.77-B, Sector-1
Gurgaon
HARYANA
122015
India
Phone +9112441900-411
Fax +911244016855
Email monika.obrah@ra
Material Support > Ranbaxy Laboratories Ltd., Plot No.20, Sector 18, Gurgaon - 122015 , Haryana
Primary Sponsor
Name Ranbaxy Laborato
, Haryana
Address
Type of Sponsor

Sponsor Nil

Recruitment India
Investigator
Dr. Suresh Patankar, AMAI Charitable Trust,
Consultant Urologist Behind Mehendale
Gavage, Erandwane
Pune 411004
Dr Girish D Bakhshi, Department of Surgery,

Associate. Professor, Grant Medical College
and Sir JJ Group of
Hospitals, Mumbai-8
Dr. Nimesh Verma, Dept of Surgery,

Associate Professor of Govt.Medical College,
Surgery Majura Gate, Surat.
Dr. Dipesh Duttaroy, Dept of Surgery,

Professor of Surgery, Medical College &
S.S.G.Hospital,
Vadodra, Gujrat.
Dr.Mahendra Parmar, Dept. of Medicine,
Associate Professor of Medical College and
Medicine, SSG Hospital,
Vadodara
Dr Rajeev Sood, MS, Dr. Ram Manohar Lohia

MCh (Urology) Senior Hospital & PGIMER
Urologist & Associate ?New Delhi ? 110001.
Professor of Urology
Dr.Arpita Dwivedy, DA, Dr.LH.Hiranandani

MD (Anaesthesiology), Hospital, Powai,
ICU Incharge, Mumbai.
Dr. Ashvin D. Gabani, Gabani Kidney

M.S, MCh (Urology), Hospital,
Consultant Urologist ?Dhanlaxmi?Complex,
and Andrologist Near Ayurvedic
College, Station- Lal
Darwaza Road, Surat,
Gujarat.
Dr. Jayaraman, Govt General Hospital

Consultant Urologist and Madras Medical
College, Chennai
Dr. Narendra Bambure, Joshi Hospital, Opp:

MD (Chest); Physician Kamala Nehru Park,
& ICU Incharge Bhandarkar Road,
Erandwane,
Pune-411044
Dr. Modi Mahavir Modi Clinic,

Madhavdas MD DNB Dr.Patwardhan
(Chest Medicine) Hospital, Dhankawal,
Pune-411043.
Dr.Yogesh Bhargava, Premier Kidney
Consultant Hospital, 17/B.Srinagar
Nephrologist, Society, Akota,
Vadodra, Gujrat
Dr. Vasudeo Ridhorkar, Ridhorkar Urology

Consultant Urologist Clinic, 2nd Floor,
Mihadia Bhawan,
Lokmat Square,
Wardha Road, Nagpur
Dr. S.N. Kalashetti, Shree Samarth

MBBS,DNB,FCPS; Hospital, Karande
Intensivist and Chowk, Omkar
Physician, Apartments, Rasta
Peth, Pune
Dr. Lalit Dongre MD, Suretech Hospital &

DM (Consultant Research Institute,
Gastroenterologist)
Dr Mukesh Kumar Jain Tagore Hospital &

Research Institute,
7-Tagore Lane,
Mansarover,
Jaipur-302020
Committee
AMAI Charitable Trust, Approved
ACE Hospital, 32/2A,
Erandwana, Behind
Mehndale Garage,
Gulwani Maharaj Road,
Pune, 411004
Ethics Committee of Approved
Biniwale Clinic, 852/1,
Dinkar Baug Apartment,
Bhandarkar Institute
Road, Pune 411004

Biniwale Clinic, 852/1,
Dinkar Baug Apartment,
Bhandarkar Institute
Road, Pune 411004
Human Research Approved

Ethics Committee, Govt
Medical College & New
Civil Hospitals, Surat

Committee C/o Maanav
Health Foundation, A-1,
Anupam Naqar,
Vadodara 390020

Committee Maanav
Health Foundation, A-1,
Anupam Naqgar,
Vadodara 390020

Committee, Govt
General Hospital,
Chennai

Committee, Grant
Medical College and Sir
J. J. Group of Hospitals,
Byculla Mumbai 400008

Committee,
Hiranandani Hospital,
Powai Mumbai

Committee, Medical
College & SSG
Hospital, Vadodara

Committee, Medical
College & SSG
Hospital, Vadodara
Maharashtra Medical Approved

Research Society ,
Pune
Midcity Independent Approved
Ethics Committee,
Nagpur
Midcity Independent Approved
Ethics Committee,
Nagpur
Swasthya Kalyan Ethics Approved
committee, Narain
Singh Road, Near
Trimurti Circle, Jaipur


Problems Studied
Intervention / Type
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details 1. Patients of eithe
informed consent
including pyelonep
intra-abdominal in
Exclusion Criteria
Details 1. Subjects with kn
carbapenem or ot
infection is judged
than 10 days of th
(including intraper
clinically significan
nosocomial pneum
ml/min), gastrointe
pseudomembrano
hematologic or ne
seizure disorders
women

Not Applicable
Random Sequence
Concealment
Clinical cure

Microbiological (eradication of pathogen)


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

Trial (Global)
Trial (India)
Publication Details
Brief Summary This study is an open-label, non-randomized, non-comparative study with an objective
safety, tolerability and efficacy of injection SUDOPEN (Doripenem 500 dry powder for
The study is being conducted at 15 centres all over India. The primary efficacy outcom
cure of patients with moderate to severe infections. Whereas the secondary efficacy m
be microbiological clearence of infection (pathogens eradication). In addition, global ev
overall tolerability will be assessed at the end of therapy, by the patient as well as phys
1-4 point scale (1=very good, 2=good, 3=poor, 4=very poor).

Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study A dose blind extension clinical trial to determine the Long-Term Safety and Efficacy of
of BG00012 Monotherapy in patients with relapsing remitting multiple sclerosis.
Scientific Title of A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Ef
Study Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Scleros
109MS303
2008-004753-14
NCT00835770
Investigator or overall Name Dr Ritika Bajaj
Trial Coordinator
Designation Associate Director
Affiliation Biogen
Address Flat 902, Tower -1
Gurgaon , Haryan
Gurgaon
HARYANA
122002
India
Phone 9717004620
Fax
Email ritika.bajaj@bioge
Details Contact De
Person (Scientific Name Dr Ritika Bajaj
Query)
Designation Associate Director
Affiliation Biogen
Address Flat 902, Tower -1
Gurgaon , Haryan
Gurgaon
HARYANA
122002
India
Phone 9717004620
Fax
Email ritika.bajaj@bioge
Details Contact D
Person (Public Query) Name Mandeep Kausha
Designation
Affiliation
Address Biogen Idec Biote
54
Gurgaon
HARYANA
122002
India
Phone 0124-4572351
Fax 0124-4572333
Email mandeep.kaushal
Material Support > Biogen Idec
Primary Sponsor
Name Biogen Idec
Address Biogen Idec Innov
Berkshire SL4 6AY

Sponsor Nil
Recruitment India

Investigator
Dr Dheeraj Khurana Post Graduate Institute
of Medical Education &
Research
Dr. M M Mehndiratta 502, Dept. of
Dr Suresh Kumar Amrita Institute of

Medical Sciences
Dr. Amitabh Ghosh Apollo Geaneagles

Hospitals
Dr. S C Mukherjee B P Poddar Hospital
and Medical Research
Limited
Dr Yashpal Singh Christian Medical

College and Hospital
Dr. Rahul Kulkarni Deenanath Mangeshkar

Hospital and Research
Centre
MAHARASHTRA
Dr Gagandeep Singh DMC Ludhiana Department of
Neurology, 3rd Floor,
EEG Lab Civil Lines
Tagore Nagar Ludhiana
Punjab
Ludhiana
PUNJAB
Dr. N. Ichaporia Jehagir Clinical 32 Sassoon

Development Centre, road,-411001
Jehagir Hospital Pune
MAHARASHTRA
Dr. Lekha Pandit Justice K S Hegde Deralakate,-

Charitable Hospital Bangalore
KARNATAKA
Dr. K Vijayan Kovai Medical Centre 3209, Avanashi
and Hospital Limited Road,-641014
Not Applicable
N/A
Dr Rangasetty M S Ramaiah Memorial M S Ramaiah Memorial

Srinivasa Hospital Hospital NEw Bel Road
MSRIT Banagalore
Bangalore
KARNATAKA
Dr. Shankar Nellikunja Mallikatta Neuro Centre Mallikatta Circle, Kadri,

Mallikatta,-575002
Bangalore
KARNATAKA
Dr J D Mukherjii Max Super Speciality Max Super Speciality
Hospital Hospital 1 Press
Enclave Road Delhi
South
DELHI
Dr Neeta Mehta Neeta Mehta Clinic Neeta Mehta Clinic

D-502, 5th Floor Rizvi
Nagar, Milan Subway
Junction S.V. Road
Mumbai
Mumbai (Suburban)
MAHARASHTRA
Dr Shalin Shah Neurology Clinic Neurology Clinic

206-7-8 Sangini
Complex Near Parimal
Railway Crossing
Ellisbridge Ahmedabad
Ahmadabad
GUJARAT
Dr. Madhuri Behari Neurology Department, Ansari Nagar,-110029

AIIMS New Delhi
DELHI
Dr. A. K. Meena Nizams Institute of ,-

Medical Sciences Hyderabad
ANDHRA PRADESH
Dr. Sudhir Kothari Poona Hospital and 27, Sadashiv

Research Centre Peth,-411030
Pune
Dr PK Sethi Sir Ganga Ram

Hospital
Dr. Pahari Ghosh Sri Aurobindo Seva

Kendra
Dr. Arun Shah TNMC & BYL Nair Ch.
Hospital
Dr. Shamsher VIMHANS

Dwivedee

Committee
Kshema Ethics Approved
Committee, K S Hegde
Medical Academy,
Nithyanand Nagar,
Deralakatte-575018;
Mangalore, Karnataka
B.Y.L. Nair CH. Approved

Hospital & T. N.
Medical Collage, 2nd
Floor, Dept. of
Pharmacology, Dr. A. L.
Nair Road, Mumbai-400
008
Ethical Committee, B P Approved

Poddar Hospital and
Medical Research Ltd,
71/1 Humanyun Kabir
Sarani, Block G, New
Alipore, Kolkatta ? 700
053
Ethical Review Board Approved

MS Ramaiah Medical
Bangalore
Ethics Committee, Approved

Poona Hospital and
Research Centre,
27-Sadahiv Peth, Pune-
411030, Maharastra

VIMHANS, 1
Institutional Area,
Nehru Nagar, New
Delhi ? 110065
Ethics Approved
Committee,H.C.J.M.R.I.
And J.C.D.C., Jehangir
Hospital, 32, Sassoon
Road, Pune -411 001,
India
Independent Ethics Approved 30/07/2011
Committee, Apollo
Gleneagles
Hospitals,58 Canal
Circular Road,Kolkata-
700054
Independent Ethics Approved 29/01/2013

committee, Mumbai
Independent Approved 12/07/2011
Institutional Ethics
Committee, Ethics
Committee of Sri
Aurobindo Seva
Kendra, Sri Aurobindo
Seva Kendra, 1H,
Gariahat Road (South),
Jodhpur Park, Kolkata ?
700068
Instituional Ethics Approved 14/08/2012

Committee
Institute Ethics Approved 02/08/2011
committee PGIMER
Chandigarh
Institute Ethics Approved 07/01/2012
Committee, All India
Institute of Medical
Sciences , Ansari
Nagar, New Delhi -
110029
Institute Ethics Submittted/Under No Date Specified

Committee, Sir Ganga Review
Ram Hospital,Old
Raender Nagar,New
Delhi - 60
Institutional Ethics Approved 15/08/2011

committee Amtita
Sciences

Committee, Deenanath
Mangeshkar Hospital
and Research Centre,
Erandwane, Pune-
411004
Committee, DMC
Ludhiana
committee, Nizam?s
Sciences, Punjagutta,
Hyderabad
KMCH Ethics Approved 16/08/2011

Committee, Kovai
Medical Center and

Hospitals,3209,
Avanashi Road,
Coimbatore-641014
Mallikatta Ethical Approved
Committee and
Charitable Trust,
Mallikatta Ethical
Committee,
Ramakrishna Complex,
Mallikatta Circle,Kadri,
Mangalore-575002
MAMC Society for Approved

Promotion of Medical
Research, Academics
block, G B pant
Hospital, N Delhi ? 110
002
Max Health Care Ethics Approved

Committee
Sujlam Independent Approved
Ethics Committee,
Ahamadabad

Intervention / Type
Intervention
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details 1. Ability to unders
provide signed an
participated in and
clinical studies 10
female subjects of
contraception duri
contraception for 3
Exclusion Criteria
Details 1. Any significant
significant conditio
excluded the subje
oral study treatme
protocol-defined re
discontinued study
relapses and did n
malignancy, sever
subjects consideri
pregnant, or breas
with the requireme
that, in the opinion

subject unsuitable
Method of Generating Stratified block randomization
Random Sequence
Concealment
Blinding/Masking Participant, Investigator and Outcome Assessor Blinded
To Evaluate The Long-Term Safety Profile Of
BG00012.

Health Economics
To Evaluate MS Lessions On MRI Scans.
To Evaluate The LT Efficacy Of Bg12 Using
Clincal Endpoints.
Total Sample Size=1700

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

Trial (Global)
Trial (India)
Publication Details
Brief Summary This study is a Dose-Blind, Multicenter, Extension Study to Determine the Long-Term S
Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting
Sclerosis that will be conducted in North America, Europe and rest of world. The prima
of this study is to evaluate the long-term safety profile of BG00012 in RRMS subjects.
participating are United States, Australia, Austria, Belgium, Belarus, Bosnia, Bulgaria,
Srpksa, Canada, Croatia, Czech Republic, Costa Rica, Estonia, France, Germany, Gre
Guatemala, India, Ireland, Israel, Italy, Latvia, Mexico, The Former Yugoslav Republic
Macedonia, Moldova, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Serb
South Africa, Spain, Switzerland, Ukraine and United Kingdom. India will be eligible to
patients in this study which are completes from the previous studies (109MS301 and 1
The CTRI registration no. for the same is "CTRI/2009/091/000088" and "CTRI/2009/09
The enrolment in India would start from Apr 28, 2010.
CTRI/2011/07/001888 [Registered on: 14/07/2011] - Trial Registered Retrospectivel

CTRI Number CTRI/2011/07/001888 [Registered on: 14/07/2011] - Trial Registered Retrospectivel
Type of Study Drug
Study Design Single Arm Study
Public Title of Study A Clinical Trial to Evaluate Safety and Tolerability of Lacosamide Injection for the treat
epilepsy
Scientific Title of A Multicenter, Open-Label, Non-Comparative Clinical Trial to Evaluate Safety and Tole
Study Lacosamide Injection in Patients with Partial Onset Seizures
CT/LACO/INJ/10-02
Investigator or overall Name Dr Ripal Gharia
Trial Coordinator
Designation Scientist I (Manag
Affiliation
Address Torrent Research
Gandhinagar
GUJARAT
382428
India
Phone 079-23969100
Fax 079-23969135
Email ripalgharia@torren
Details Contact De
Person (Scientific Name Dr Ripal Gharia
Query)
Affiliation
Gandhinagar
GUJARAT
382428
India
Phone 079-23969100
Fax 079-23969135
Details Contact D
Person (Public Query) Name Dr Ripal Gharian
Affiliation
Gandhinagar
GUJARAT
382428
India
Phone 079-23969100
Fax 079-23969135
Material Support > Torrent Pharmaceuticals Ltd
Primary Sponsor
Name Torrent Pharmace
Address Torrent Pharmace
Gandhinagar - 382

Sponsor Not Applicable
Recruitment India

Investigator
Dr Ravindra Lodha 4, Nalkung Society,
Dr Praveen Gupta Artemis Health Institute,

Gurgaon.
Dr Rajaram Agrawal Brain Care, Prince

Road,Jaipur.
Dr B S Keshava City Neuro Centre,l

Mysore
Dr. Bashir Ahmadi M-4, Mahakant
Building, Mezzanine
Floor,
Dr Rajnish Kumar Paras Hospitals,

Gurgaon.
Dr G R K Sarma St. Johns Medical

College Hospital,
Department of
Neurology,Banglore.
Dr Sanjay S Varade Suman Hospital,
College Road, Nasik
Dr Rajendra I Dugani Vivekanand Hospital

Road, Hubli-580029

Committee
Artemis Health Approved
Sciences Institutional
Review Board
Clinical Ethics Forum Approved
for Dr Bashir
for Dr Dugani
for Dr Keshava
for Dr Lodha
for Dr. Sanjay Varade
Paras Hospital Approved
St. Johns Medical Approved
College & Hospital
Institutional Ethical
Review Board for Dr. G
R K Sarma
Swastik Ethics Approved

Committee for Dr.
Rajaram Agrawal

Intervention / Type
Inclusion Criteria
Gender Both
Details
Exclusion Criteria
Details 1. Patients with ab
intravenous injecti
2. Patients with se
3. Patients with St
4. Patients with hi
5. Patients with kn
and/or excipients
6. Patients with liv
and/or bilirubin mo
creatinine more th
7. Patients with pr
system or progres
disorders like mult
8. Patients with ca
prolong P-R interv
9. Patients with cli
10. Patients with s
Bipolar disorder w
11. Use of neurole
analgesics within
12. Patients who h
trial within the four
13. Women patien
acceptable (non-h
14. Pregnant or la
years

Random Sequence
Concealment
Adverse Event Assessment
Local adverse events at injection site
Changes in vital signs
Changes in ECG finding
Changes in laboratory parameters

Maintenance of seizure frequency during trial
period


Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0
Not Applicable
Trial (Global)

Trial (India)
Publication Details Not Applicable
Brief Summary This is an Open label, Non-Comparative, Multicentric Safety & Tolerabilit
Trial with primary objective is to evaluate the safety and tolerability of Lac
Injection in the patient with partial onset seizures.

Type of Study Drug
Public Title of Study A phase 3 clinical trial to study the efficacy and safety of drug fasudil in comparison wit
in patients with non-traumatic subarachnoid hemorrhage
Scientific Title of An open label, randomized, parallel group, prospective, multicentre clinical trial for eva
Study efficacy and safety of fasudil hydrochloride in comparison with nimodipine following no
subarachnoid hemorrhage

CT/ FSDL/SAH/PHASE III/10
Investigator or overall Name Dr Rajendra C Ra
Trial Coordinator
Designation Sr Vice President
Affiliation Intas Pharma
Address Intas Pharmaceut
Intas Pharmaceut
Ahmadabad
GUJARAT
380009
India
Phone 26576655
Fax 26576616
Email rane@intaspharm
Details Contact De
Person (Scientific Name Dr Kanhei Charan
Query)
Designation Medical adviser
Ashram Road
Ahmadabad
GUJARAT
380009
India
Phone 66523302
Fax 26576616
Email Kanheicharan_sah
D
Details Contact D
Person (Public Query) Name Dr Dimple Shah
Ashram Road
Ahmadabad
GUJARAT
380009
India
Phone 66523298
Fax 26576616
Email dimple_shah@inta
Material Support > Intas Pharmaceuticals Limited, Ahmedabad
Primary Sponsor
Name Intas Pharmaceut
Ahmadabad GUJA

Sponsor Nil
Recruitment India
Investigator
Dr. Sumit Sinha All India Institute of
Medical Sciences
(AIIMS)
Dr. Rajendra Kabaria Ashirwad Nursing
Home
Dr. Nitin Sampat Bhatia Hospital

Hospital
Dr. C K Pakmode Getwell hospital
Dr. Nasli.R. Ichaporia Jehangir Hospital
Dr. Agasti Krishna Krishna Institue of

Reddy Medical Sciences
Dr Umesh Kalra Sarvodaya
Multispeciality Hospital
Dr. Ramesh Madhav Shree Hospital

Patankar
Dr. Manish A. Rathi Siddhi Vinaya
Dr. C.S. Agarwal Sir Ganga Ram

Hospital
Dr. Parimal Tripathi Sterling Hospital
Dr. Sameer Paltewar Suretech Hospital and

Research Centre
Dr. Nirmal Surya Surya Neuro Centre

Committee
Committee - Aditya for
Dr. Nirmal Surya
Dr. Rajendra Kabaria
Dr. Ramesh Madhav
Patankar

Dr. Umesh Kalra
Committee, Bhatia
Hospital, Mumbai for
Dr. Nitin Sampat

Mangeshkar Hospital
and Research Centre,
Pune for Dr. Rahul
Kulkarni

Committee, KIMS
Hospital, Secunderabad
for Dr. Agasti Krishna
Reddy

Committee, Sir Ganga
Ram Hospital, New
Delhi for Dr. C.S.
Agarwal
Sterling Hospital Ethics Approved

Committee,
Ahmedabad for Dr.
Parimal Tripathi

Intervention / Type
Comparator Agent
Inclusion Criteria

Gender Both
Details 1)Either sex, age
non-traumatic SAH
females with child
at screening and w
through out the stu
accepted represen
consent 4)Fo
hours of detection
Exclusion Criteria
Details 1)Recent history o
with hypotension (
baseline 3)Patient
with subarachnoid
cerebrovascular d
and severely raise
lactation 6)Patient
requiring inotropic
function impairme
normal limit) or ren
1.5 times upper no
medications ? vas
3A4, intravenous b
enrollment by inve

Random Sequence
Concealment
Blinding/Masking Open Label
Outcome
Delayed Ischemic Neurological Deficits

1) Neurological worsening
2) Requirement of administration of a valid
rescue therapy
3) 3 or score of Modified Rankin Scale


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

Trial (Global)
Recruitment Status of Suspended
Trial (India)
Publication Details Nil
Brief Summary To compare the efficacy and safety of fasudil with nimodipine in adult patients hospital
non-traumatic SAH. Cerebral vasospasm constitutes a major complication of subarach
hemorrhage. Percentage of patients developing DIND (Delayed Ischemic Neurological
to vasospasm during study medication period (defined by low density lesion on CT sca
with neurological worsening) in each group would be considered as primary outcome.
efficacy parameters include neurological worsening (defined as a decline of at least 2 p
Glasgow Coma Scale or an increase of at least 2 points in the abbreviated National Ins
Health Stroke Scale), administration of rescue therapy for DIND and modified Rankin S
for residual disability at the end of the study. The hemodynamic therapy (Tiple H therap
angioplasty will be allowed as rescue therapy. The trial will be conducted in Indian pati
within India only. Anticipated date for first patient enrolment in the study is 03-08-2010.

Type of Study Drug
Public Title of Study CLINICAL TRIAL OF ELETRIPTAN TO TREAT ACUTE MIGRAINE ATTACKS IN ADU
PATIENTS
Scientific Title of A MULTICENTRE, OPEN-LABEL, ACTIVE-CONTROLLED, COMPARATIVE, RANDO
Study PARALLEL-GROUP CLINICAL TRIAL OF ELETRIPTAN ORAL TABLET FORMULATI
ADULT MIGRAINE PATIENTS ACROSS THREE ATTACKS

INTAS/CT//ELTR/MGR/III/10
Investigator or overall Name Dr Rajendra C Ra
Trial Coordinator
Designation Sr Vice President
Ahmadabad GUJA
Chinubhai Center
India
Ahmadabad
GUJARAT
380009
India
Phone 26576655
Fax 26576616
Email rane@intaspharm
Details Contact De
Person (Scientific Name Dr Parag Bhattach
Query)
Affiliation AGM Medical Ser
Ahmadabad
GUJARAT
380009
India
Phone 66523223
Fax 26576616
Email parag_bhattachar
Details Contact D
Person (Public Query) Name Dr Dimple Shah
Ahmadabad GUJA
Chinubhai Center
India
Ahmadabad
GUJARAT
380009
India
Phone 66523414
Fax 26576616
Email dimple_shah@inta
Material Support > Intas Pharmaceuticals Limited, Ahmedabad
Primary Sponsor
Name Intas Pharmaceut
Ahmadabad GUJA

Sponsor Nil

Recruitment India
Investigator
Dr. Pranav Joshi "Archanam" Neuro
Clinic
Dr Sunit Kumar Shah Advanced Neurology

and Superspeciality
Hospital
Dr. Atul Taparia Bombay Hospital
Dr. Girish C. Nair Dept. of Neurology, D Y

Patil Hospital
Dr. Ravindra Lodha Dr. Ravindra Lodha's

Clinic
Dr. Tarun Nagpal Nagpal Neuro Medical

Centre
Dr. Dharmeshkumar N. Neuro Care Clinic and

Patel Research Centre
Dr. Mrs. Priyanka V. Neuro Care Speciality

Kashyap Clinic
Dr. Parthiv Desai Neurocar
Electrophysio
Dr. Ajay Kumar Vatsa Neurology Centre
Dr. Sunil Malik Neurology Centre
Dr. Dinesh Udainiya Neurology Clinic
Dr. Anupam Sahni Sahni Neuro Care

Centre
Dr. R. S. Jain SMS Hospital
Dr. Ganesh Kini Vimala Neurology

centre and EEG Clinic

Committee

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Anupam Sahni
Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Anupam Sahni

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Dharmeshkumar N.
Patel

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Dinesh Udainiya

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Parthiv Desai

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Pranav Joshi

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Ravindra Lodha

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Sunit Kumar Shah

Committee for
Research in human
Subjects (IECRHS),
Ahmedabad for Dr.
Tarun Nagpal
SMS Hospital Ethics Approved

Committee for Dr. R. S.
Jain

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 1)Male and female
diagnosis of migra
Headache Society
prophylactic treatm
episodes is 1 to 6
is 1 year 5)M
6)Female patients
following additiona
child-bearing pote
contraception, and
contraception befo
sterilised, or has a
sterilization -
test at screening<
are willing to provi
understand the pu
are willing to partic
to fill-up the migra
attack and up to th
period 9)Sub
medication. 
Exclusion Criteria
Details A patient is exclud
following criteria: 1
respond to migrain
headache (e. g., m
3)Presence of mig
migraine, basilar m
unstable medical c
limited gastrointes
documented hype
drugs 7)Use of dru
misuse of analges
>100 tablets of an
use on >2 days pe
substances, based
Mental Disorders
abnormal laborato
baseline electroca
"within normal limi
prior to screening
consent 14)Not wi
of migraine 15) Pr
of child-bearing po
precaution 17)Wo
use barrier contra
non-compliance w

Random Sequence
Concealment
2-h headache response

(1)Functional response
(2)2-h pain-free response
(3)Relief of migraine-associated symptoms
(4)Overall patient acceptability of the study
medication
(5)Consistency of headache response at 2 hours


Enrollment (India)
Enrollment (Global)
Trial Months=10
Days=0

Trial (Global)
Trial (India)
Publication Details Nil
Brief Summary This trial has been designed for evaluation of the safety and efficacy of eletriptan 40mg
formulation versus sumatriptan 50mg oral tablet formulation in adult patients with multi
of migraine headache. Eletriptan 40 mg tablet is expected to be as effective as, and be
than, Sumatriptan 50 mg tablet in acute treatment of migraine in adult patients. The tria
conducted in adult Indian patients only and within India only. Anticipated date for first p
enrolment in the study is 5th week of May 2010.

Type of Trial
Type of Study
Public Title of Study Meaningful task specific training for evaluation of functional and neuroplastic changes
patients
Scientific Title of Meaningful task specific training for evaluation of functional and neuroplastic changes
Study patients
NIL
Investigator or overall Name Prof. Rajesh Verm
Trial Coordinator
Designation
Affiliation
Address Department of Ne
Lucknow
UTTAR PRADESH
226003
India
Phone 08127442407
Fax
Email drrajeshverma32@
Details Contact De
Person (Scientific Name Prof. Rajesh Verm
Query)
Designation
Affiliation
Lucknow
UTTAR PRADESH
226003
India
Phone 08127442407
Fax
Details Contact D
Person (Public Query) Name Prof. Rajesh Verm
Designation
Affiliation
Lucknow
UTTAR PRADESH
226003
India
Phone 08127442407
Fax
Material Support > NIL
Primary Sponsor
Name NIL
Address
Type of Sponsor

Sponsor NIL
Recruitment India
Investigator
Prof. Rajesh Verma Dept. of Neurology,
CSMMU, Lucknow, UP,
India.

Name of Committee Approval Status
Committee
CSMMU Institutional Approved
Ethical Committee


Problems Studied
Intervention / Type
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details Age: 18 to 60 yea
& left) unilate
intensive training p
instructions 4 to 2
1,1+, 2, Brunnstro
Ambulation Classi
Exclusion Criteria
Details Severe Aphasia (N
Uncontrolled syste
Shoulder subluxat
stroke Ataxia Seve
in any Pharmacolo
of Health Stroke S

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment

Fugl Meyer Assessment (FMA) Action Research
Arm Test (ARA) Motor Activity Log (MAL) Wolf
Motor Function Test (WMFT)
Outcome
Stroke Impact Scale (SIS)

Phase of Trial N/A

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

Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details
Brief Summary Stroke remains a leading cause of disability in many countries including India. It can ca
in a number of neurologic domains, most commonly in the motor system.Standard mot
rehabilitation after hemiparetic stroke typically involves an eclectic mix of approaches.
therapeutic method gives remarkable improvement for motor deficit, making motor reh
stroke a major challenge.Further there is no strong clinical & research evidence for the
Task-specific training which focuses on the practice of skilled motor performance is the
to facilitate neural reorganization and "rewiring" in the central nervous system (CNS) N
studies have been done on task specific training; however type of task and specific me
training which can lead to better functional and neuroplastic changes in stroke patients
been established yet. Hence there is need to develop more specific training methods b
meaningful task which would lead to better functional and neuroplastic changes in Stro

Post Graduate Thesis Yes
Type of Study Surgical/Anesthesia
Study Design Randomized, Parallel Group Trial
Public Title of Study Effectiveness of early surgery over usual waiting list surgery (medical therapy) in Child
Refractory Epilepsy-(CDRE)
Scientific Title of A Randomized controlled trial of early versus usual waitng list surgery in childhood intr
Study epilepsy
NIL
Investigator or overall Name Manjari Tripathi
Trial Coordinator
Designation Additional Profess
Affiliation Dept.of Neurology
Address Room No-705, 7th
New Delhi
DELHI
110029
India
Phone 011-26594494
Fax
Email manjari.tripathi@g
Details Contact De
Person (Scientific Name Dr Manjari Tripath
Query)
Affiliation Dept of Neurology
Address Room No-705,7th
New Delhi
DELHI
110029
India
Phone 011-26594494
Fax
Details Contact D
Person (Public Query) Name Rekha Dwivedi
Designation
Affiliation
Address Room No-705,Dep
New Delhi
DELHI
110029
India
Phone 011-26594494
Fax
Email rekha.dwivedi2006
Material Support > All India Institute of Medical Sciences (AIIMS)
Primary Sponsor
Name All India Institute o
Address Ansari Nagar New
Type of Sponsor Research institutio

Sponsor NIL
Recruitment India
Investigator
DrManjari Tripathi AIIMS

Committee
AIIMS Approved
All India Institute of Approved
Medical Sciences
Data Safety Approved
Management Board
DSMB Approved

Patients
Intervention / Type
Comparator Agent
Inclusion Criteria
Age From 1.00 Month(s)
Gender Both
Details 1) All children with
Patients having D
tolerated and appr
schedules for yea
 3)All patient
surgery-case conf
or Legally Accepta
Consent for partic
Exclusion Criteria
Details 1) All patients who
abnormality, renal
2) Those patients
immediate surgery

Random Sequence
Concealment
Blinding/Masking Outcome Assessor Blinded
The primary outcome will be to assess the
seizure freedom between the two groups by
International League Against Epilepsy (ILAE)
Scale or Engels Scale at 12 months

To assess the differences in the occurrence of
seizures over a period of 12 months, and
seizure-severity, cognition, behavior and quality
of life by the following measures: the Hague
seizure Severity (HASS) scale, Binet Kamat Test
(BKT ) and Vineland Social Maturity Scale
(VSMS), Child Behavior Check List (CBCL)
,Pediatrics Quality of Life (PedsQL), respectively.


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

Trial (Global)
Completed
Trial (India)
Publication Details under revision
Brief Summary This study is a randomized controlled trial to assess the efficacy of the early epilepsy s
over usual-dated epilepsy surgery (with continued medical therapy) in surgically remed
childhood drug refractory epilepsy. It is being conducted in All India Institute of medica
(AIIMS), New Delhi. The primary objective of this study is to assess the outcome of sei
epilepsy surgery (Intervention group) versus the usual waiting list surgery with medical
(non-intervention group) at 12 months.The secondary objective of the study is to evalu
severity, cognition, behavior and quality of life through clinical and neuro-psychologica
by Binet Kamat Test (BKT),Vineland Social Maturity Scale (VSMS), Chil
the Hague Seizure Severity (HASS) scale,
Check List (CBCL) and Pediatrics Quality of Life (PedsQL), respectively between the tw

Type of Study Drug
Study Design Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study A Study of YM178 in Subjects With Symptoms of Overactive Bladder
Scientific Title of Phase III study of YM178 - A randomized, double-blind, parallel group, placebo and ac
Study controlled, multi-center study in subjects with symptoms of overactive bladder
178-CL-090, Ver 2.0 dtd 28-01-10, Addendum 3
dtd 22-02-11
NCT01043666
Investigator or overall Name
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact De
Person (Scientific Name Dr Shoibal Mukhe
Query)
Designation Vice President, M
Affiliation IQVIA RDS (India
Address 8th Floor, DLF Sq
Gurgaon, Haryana
Gurgaon
HARYANA
122002
India
Phone 91-7838652395
Fax
Email shoibal.mukherjee
Details Contact D
Person (Public Query) Name Suchela Srivatsa
Designation Director – Clinical
Affiliation IQVIA RDS (India
Address 301-A-1, Leela Bu
400059
Mumbai
MAHARASHTRA
400059
India
Phone 91-9820712114
Fax 91-22-56774343
Email suchela.srivatsa@
Material Support > Astellas Pharma Inc. 17-1, Hasune 3-chome, Itabashi-ku, Tokyo 174-8612 Japan
Primary Sponsor
Name Astellas Pharma I
Address 17-1, Hasune 3-ch

Sponsor Quintiles Research India Private Limited
Quintiles Research India Private Limited

Recruitment China
India
Republic of Korea
Taiwan

Investigator
Dr. Rajeev Sood Dr. Ram Manohar Lohia
Hospital & PGI MER
Dr. Nayan Kumar Government Of India,

Mohanty Department Of Urology,
V.M. Medical College &
Safdarjang Hospital
Dr. N. Subramaniam Indraprastha Apollo

Hospitals
Dr. Rajesh Kumar Medanta, The Medicity

Ahlawat
Dr. Sunder Lal Tolani Monilek Hospital &

Research Centre
Dr. Shimpi Rajendra Noble Hospital

Kashinath
Dr. Janak D. Desai Samved Hospital
Dr Rakesh Kapoor Sanjay Gandhi Post

Graduate Institute Of
Medical Sciences

Committee
Ethics Committee on Approved
Clinical Trials,
Indraprastha Apollo
Hospitals, New Delhi-
Dr. N. Subramaniam

Samved Hospital,
Ahmedabad- Dr. Janak
Desai
Ethics Committee, V.M Approved

Medical College &
Safdarjang Hospital,
New Delhi- Dr. N. K.
Mohanty

Committee, Dr. Ram
Manohar Lohia
Hospital, New Delhi -
Dr. Rajeev Sood

Committee, Monilek
Hospital & Research
Centre, Jaipur - Dr.
Tolani Sundar Lal

Committee, Noble
Hospital, Pune- Dr.
Shimpi Rajendra
Kashinath

Committee, Sanjay
Gandhi Post Graduate
Institute Of Medical
Sciences, Raebareli
Road,
Lucknow-226014, India-
Dr. Rakesh Kapoor
Madanta Independent Approved

Ethics Committee,
Gurgaon, Haryana - Dr.
Rajesh Kumar Ahlawat

Patients
Intervention / Type
Comparator Agent
Comparator Agent
Inclusion Criteria

Gender Both
Details Ages Eligible for S
for Study: Both, Inclusion Cr
overactive bladde
Subjects capable
measuring the urin
average frequency
period 4. Su
incontinence of on
Subject having pro
 
Exclusion Criteria
Details 1. Subject having
symptom 2. Subje
overactive bladde
urinary stones, an
of recurrent urinar
bladder tumor/pro
Subject confirmed
with a clinically sig
Subject with indwe
self-catheterizatio
tract functions, or
Subject giving sur
functions within 24
uncontrolled hype
DPB >= 110mmH
bpm
Method of Generating Stratified randomization

Random Sequence
Centralized
Concealment
Change in mean number of micturitions per 24
hrs

Change in mean number of nocturia episodes
Safety assessed by vital signs, adverse events
laboratory findings, 12-lead electrocardiogram
and post-void residual volume
Change in mean number of urgency episodes
per 24 hrs
Change in mean number of urinary incontinence
episodes per 24 hrs
Change in mean number of urge incontinence
episodes per 24 hrs
Change in mean volume voided per micturition


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

Trial (Global)
Trial (India)
Publication Details None yet
Brief Summary This is a randomized, double-blind, parallel group, multi-center study to assess the effi
safety of YM178 in subjects with symptoms of overactive bladder. Globally 1300 subje
enrolled in the study. From India, it is planned to enroll 333 subjects. Tentative date for
enrollment at Indian site is June 15, 2010. This clinical trial is conducted with condition
from India regulatory authority (to enroll subjects of age >= 18 years and =< 65 years).

Type of Trial
Type of Study
Public Title of Study Task-oriented Circuit Class Training Program with Motor Imagery for Gait Rehabilitatio
Stroke patients
Scientific Title of Task-oriented Circuit Class Training Program with Motor Imagery for Gait Rehabilitatio
Study Stroke patients
NIL
Investigator or overall Name Prof. Rajesh Verm
Trial Coordinator
Designation
Affiliation
Lucknow
UTTAR PRADESH
226003
India
Phone 05222253158
Fax
Details Contact De
Person (Scientific Name Prof. Rajesh Verm
Query)
Designation
Affiliation
Lucknow
UTTAR PRADESH
226003
India
Phone 05222253158
Fax
Details Contact D
Person (Public Query) Name Prof. Rajesh Verm
Designation
Affiliation
Lucknow
UTTAR PRADESH
226003
India
Phone 05222253158
Fax
Material Support > NIL
Primary Sponsor
Name NIL
Address
Type of Sponsor

Sponsor NIL
Recruitment India
Investigator
Kamal Narayan Arya Department of
Neurology

Committee
CSMMU Ethics Approved
Committee


Problems Studied
Intervention / Type
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details ?Age: 18 to 60 ye
haemorrhagic stro
(both right &
?able to cope with
instructions ?abilit
Classification II &a
Exclusion Criteria
Details ?Cerebellar or tha
?Cardiovascular p
contractures of ga

Random Sequence
Concealment

Functional Ambulation Classification The
Rivermead Visual Gait Assessment form

Walking distance: Six Minute Walk Test (6MWT)
Walking speed: Ten Meter Walk speed (10MWS)
Timed Up and Go (TUG)

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=10
Days=0

Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details
Stroke is the leading cause of disability in adults. 75% percent of individuals who susta
each year report limitations in mobility that usually is related to walking. While the majo
survivors will regain some ability to walk, 40% will require assistance with walking and
are independent, 60% will be limited in community ambulation.Rehabilitation provided
with hemiparesis in the weeks following their strokes frequently consists of exercise the
on neuromuscular re-education, as well as on the practice of pre walking functional tas
transfer activities, weight shifts in sitting or standing, and the maintenance of unassiste
Walking practice is usually limited in time (practiced once or twice a day for only a few
Brief Summary Stroke is the leading cause of disability in adults. 75% percent of individuals who susta
each year report limitations in mobility that usually is related to walking. While the majo
survivors will regain some ability to walk, 40% will require assistance with walking and
are independent, 60% will be limited in community ambulation.Rehabilitation provided
with hemiparesis in the weeks following their strokes frequently consists of exercise the
on neuromuscular re-education, as well as on the practice of pre walking functional tas
transfer activities, weight shifts in sitting or standing, and the maintenance of unassiste
Walking practice is usually limited in time (practiced once or twice a day for only a few
space (within institutional confines). Recent evidence has highlighted the importance o
practice of the walking task itself, as well as the need to adjust the conditions of walkin
(eg, walking surface, environment), to the life conditions of the individual.Another cost
possibility of enhancing gait performance in this group of patients through the nonhaza
intensive self-practice of gait activities in their own homes may be realized through the
imagery (MI) in the mental practice of walking tasks. Since MI practice alone can not s
problem of gait, it should be followed by motor based protocol. In the absence of any s
effective gait protocol, combining MI practice with Task oriented Circuit Class training f
rehabilitation of post stroke patients may be a novel approach.

Type of Study Drug
Public Title of Study A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Parti
Seizures (CATZ Extension Study)
Scientific Title of An Open-label Extension Study Following a Double-blind, Randomised, Placebo-contr
Study Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paed
Onset Seizures.

E2090-E044-313
NCT01136954
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email
Details Contact De
Person (Scientific Name Dr Shoibal Mukhe
Query)
Designation Vice President, M
Affiliation Quintiles Researc
Address 8th Floor, DLF Sq
Gurgaon, Haryana
Gurgaon
HARYANA
122002
India
Phone 91-7838652395
Fax
Email shoibal.mukherjee
Details Contact D
Person (Public Query) Name Suchela Srivatsa
Designation Director – Clinical
Affiliation Quintiles Researc
Address 301-A-1, Leela Bu
400059
Mumbai
MAHARASHTRA
400059
India
Phone 91-9820712114
Fax 91-22-56774343
Email suchela.srivatsa@
Material Support > Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL1
United Kingdom Tel: +44(0) 20 8600 1400 Fax: +44(0) 20 8600 1401
Primary Sponsor
Name Eisai Limited
Address European Knowle
HertfordshireAL10

Sponsor Quintiles Research India Private Limited

Recruitment Belgium
Estonia
France
Hungary
India
Italy
Latvia
Poland
Spain
Ukraine
United Kingdom

Investigator
Dr Chandrashekhar Brain and Min
Meshram
Dr. Vineet Gupta Indraprastha Apollo

Hospital
Dr. Anaita Udwadia Jaslok Hospital and

Hegde Research Centre
Dr. V. Vishwanathan Kanchi Kamakoti Child
Trust Hospital
Dr Nandan Yardi KEM Hospital, KEM

hospiatl Research
centre
Dr. Shankara Nellikunja Mallikatta Ne
Dr Atul Agarwal Neurology Clinic
Dr. S.A. Jabeen Nizam's Institute of

Medical Sciences
Dr. Sangeeta H. Ravat Seth G. S.

College & KE

Committee
Central India Medical Approved
Research Ethical
Committee, Nagpur- Dr.
Chndrashekhar
Meshram
Ethics Committee Child Approved

Trust Medical Research
Foundation, Chennai-
Dr. V. Vishwanathan
Ethics Committee for Submittted/Under

Research on Human Review
Subject (ECRHS)
Ethics Committee Approved
Jaslok Hospital and
Research Centre
Mumabi- Dr. Anita
Hegde
Ethics Committee on Approved

Clinical Trial,
Indraprastha Apollo
Hospital, New Delhi- Dr.
Vineet Gupta

Committee-Nizams
sciences Hyderabad-
Dr. S. A. Jabeen
KEM Hospital Research Approved

Centre Ethics
Committee, Pune- Dr.
Nandan Yardi
Lucknow Independent Approved

Ethics Committee,
Lucknow UP- Dr. Atul
Agrawal
Mallikatta Ethical Approved

Committee, Mangalore-
Dr. Shankar Nellikunja

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 1.Subject has com
E2090-E044-312.
informed consent
consent. 3.S
who is willing to gi
applicable. If man
relevant age will b
consent. 4.S
medical history, ph
results. 
Exclusion Criteria
Details 1.Subject has a bo
history of renal ca
μmol/l (1.5 m
immunodeficiency
history of sensitivi
excipients. 5.Fem
bearing potential (
to take a medically
contraceptive pill,
contraception, or i
abstain from sexu
month after the las
Should a female s
study, they must b
testing and either
appropriate form o
excessive alcohol
suicide attempt. 8
9.Subject has a hi
treatment or subje
expected not to be
the study. 10.Freq
week). 11.Concom
inhibitors such as
anticholinergic act
felbamate within 3
study.

Random Sequence
Concealment
Blinding/Masking Participant and Investigator Blinded
Outcome
The primary objective of this study is to assess
the long-term safety of zonisamide in pediatric
subjects treated with one or two other
anti-epileptic drugs (AEDs).

Efficacy endpoints to assess long term
maintenance of efficacy will be investigated.


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

Trial (Global)
Trial (India)
Publication Details None
Brief Summary Those subjects who completed the double-blind study (E2090-E044-312) will be invite
participate in this extension study. The study consists of two main parts: Transition Per
(double-blind) and Open Label Period. The study will start with the Transition Period du
subjects already on zonisamide will continue on the same dose of zonisamide and tho
taking placebo will be up-titrated to an appropriate dose of zonisamide. After all subjec
completed the Transition Period, the study will become open-label with every subject o
receiving zonisamide. The study medication will be taken once daily in the evening. Fo
subjects previously in the placebo group, dosing with zonisamide will start with a dose
approximately 1 mg/kg. In order that the blind is maintained from the previous study, th
will initially continue taking the same number of placebo capsules as they were taking
Maintenance Period of the E2090-E044-312 study until the up- titration is completed. T
subjects previously in the zonisamide arm will continue on the same dose which they r
during the Maintenance Period of the E2090-E044-312 study. In order that the blind is
they will also take placebo capsules in order to mirror the up- titration dose regimen of
previously randomized to receive placebo in the E2090-E044-312 study. All subjects w
placebo capsules after the Transition Period is complete. The duration of the Transition
depends on the dose the subject appeared to have received when completing the core
E2090-E044-312. For those who completed on 8 mg/kg, the Transition Period will last
those on 6 mg/kg, the Transition Period will last 5 weeks. However, during the double-
Transition Period, some subjects may experience adverse events (AEs). If this should
subject may be down titrated to one level above the minimal dose. The overall duration
will be up to 59 weeks. Globally 204 subjects are to be enrolled in the trial whereas fro
patients are to be participated. Anicipated date of enrollment: January 19, 2011 Please
refernced study is roll over study of E2090-E044-312 which is already registered at CT
vide CTRI registration number: CTRI/2010/091/000158

Last Modified On
Type of Trial
Type of Study
Public Title of Study Efficacy and safety of Dapoxetine Hydrochloride Tablet in treatment of Premature Ejac
Scientific Title of Clinical study to evaluate efficacy and safety of Dapoxetine Hydrochloride Tablet in tre
Study Premature Ejaculation.
EPL/2009/DAP/01
Investigator or overall Name Dr. Hemang Desa
Trial Coordinator
Designation
Affiliation
Address 306, Sangini Com
Ellisbridge,
Ahmadabad
GUJARAT
380006
India
Phone
Fax
Email niyatide@gmail.co
Details Contact De
Person (Scientific Name Dr. Onkar Swami
Query)
Designation
Affiliation Emcure Pharmace
Address Emcure Pharmace
Hinjwadi
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019
Email Onkar.Swami@em
Details Contact D
Person (Public Query) Name Dr. Onkar Swami
Designation
Affiliation
Hinjwadi
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019
Material Support > Emcure Pharmaceuticals Ltd, Pune
Primary Sponsor
Name Emcure Pharmace
Address
Type of Sponsor

Sponsor NONE
Recruitment India
Investigator
Dr. Rohan D. Aashray Clinic
Kusumgar, MD (Psy)
Dr. Anjanappa Abhaya Hospital

Jagadish, MBBS, MD
(Psy)
Dr. Abhay Paliwal, Dr. Abhay Paliwal

MBBS, MD (Psy)
Dr. Hemang Desai, MD Dr. Hemang Desai

(Psy), DPM
Dr. Pratap V. Panhale, Dr. Pratap Panhale?s

MBBS, DPM Clinic
Dr. Sanjay Phadke, MD Dr. Sanjay Phadke's

(Psy), DPM Clinic
Dr. Vilas Bhailume, Dr. Vilas Bhailume,

MBBS; DPM MBBS; DPM
Warje Road, -411052

Pune
MAHARASHTRA
Dr. Rajan B. Bhonsle, Heart to Heart 10, Jerbai Baug, Near
MD (Bom) Counselling Centre Gloria Church,,B.A.
Road, Byculla
(East),-400027
Mumbai
MAHARASHTRA
Dr. P. N. Suresh IQRAA International Malaparamba,-673009

Kumar, MD, DPM, DNB Hospital and Research Not Applicable
Center N/A
Dr. Kausar Abbasi, Jeswani Hospital 2nd floor, Parekh
MBBS, DPM Center,Opp. Daga
Hospital, Gandhi
Bag,-440018
Nagpur
MAHARASHTRA
Dr. C. M.S. Chellamuthu Trust 611, K K

Ramsubramanian, MD, Research Foundation Nagar,-625020
DPM Madurai
TAMIL NADU
Dr. Sundeep Jadhav, Manav 1st Floor, Above HDFC

MD, DPM, FIPS Neuropsychiatric Bank, Santoshi Mata
Hospital Pvt Ltd Road, ,Saraswati
Building,-421301
Not Applicable
N/A
Dr. Dinesh V. Tembe, Manovedh Clinic 119, Niranjan, Budhwar

DNB, DPM Peth,Station Road-
Not Applicable
N/A
Dr. Avinash Phadnis, Oyster and Pearl 1671-75, Ganesh Khind

MD Hospital Road, ,Behind Hotel
Pride, Shivaji
Nagar,-411005
Pune
MAHARASHTRA
Dr. Umesh Nagapurkar, Psychiatry Clinic Malpani Pride, Near

MD (Psy), DPM Raymond
Showroom,,Sharanpur
Road-422002
Not Applicable
N/A
Dr. Ketan Pai, DNB Sahyadri Hospitals Ltd 30 C Erandwane, Karve

(Gen. Surg), DNB Road,,-411004
(Urology) Pune
MAHARASHTRA
Dr. Ujwal Sardesai, MD Samvedana 312 Starlit Towers, Y.

N. Road,-452003
Indore
MADHYA PRADESH
Dr. Mrugesh Vaishnav, Samvedana Hospital Below Karnawati Hospit

MD (Psy) al,Ellisbridge-380006
Ahmadabad
GUJARAT
Dr. Sanjeev Saoji Saoji Tupkari Hospital 4, Vijay Nagar, ,Opp.
Jawahar Nagar Police
Dr. Milind B. Bapat, MS Sardesai Clinic

(Gen Surg), DNB (Uro)
Dr. Arun Marwale, Shradha Nursing Home

MBBS, DPM, DNB
(Psy)
Dr. Mahesh Ramanna Spandana Nursing

Gowda, DNB (Psy) Home
Dr. Ketan C. Parmar, Swaminarayan Clinic

MD, DPM, FIPS and Nursing Home
Dr. Rajesh Goyal, MD Tan-Man Clinic

Committee
Abhaya Ethics Approved
Committee for Dr.
Anjanappa Jagadish
Dr. Babasaheb Approved
Ambedkar Medical
Research Society's
Ethics Committee for
Dr. Sanjeev Saoji
Ethics Committee M.S. Approved
Chellamuthu Trust and
Research Foundation
for Dr. C.
Ramasubramanian

Committee,
Dhanashree Hospital
for Dr. Abhay Paliwal

Committee,
Dhanashree Hospital
for Dr. Arun Marwale

Committee,
Dhanashree Hospital
for Dr. Dinesh V.
Tembe
Independent Ethics Approved No Date Specified
Committee,
Dhanashree Hospital
for Dr. Hemang Desai

Committee,
Dhanashree Hospital
for Dr. Kausar Abbasi

Committee,
Dhanashree Hospital
for Dr. Ketan Parmar

Committee,
Dhanashree Hospital
for Dr. Milind Bapat

Committee,
Dhanashree Hospital
for Dr. Mrugesh
Vaishnav
Committee,
Dhanashree Hospital
for Dr. P. N. Suresh
Kumar

Committee,
Dhanashree Hospital
for Dr. Pratap V.
Panhale

Committee,
Dhanashree Hospital
for Dr. Rajan B.
Bhonsle

Committee,
Dhanashree Hospital
for Dr. Rajesh Goyal

Committee,
Dhanashree Hospital
for Dr. Rohan
Kusumgar

Committee,
Dhanashree Hospital
for Dr. Sanjay Phadke

Committee,
Dhanashree Hospital
for Dr. Sundeep Jadhav

Committee,
Dhanashree Hospital
for Dr. Ujwal Sardesai

Committee,
Dhanashree Hospital
for Dr. Umesh
Nagapurkar
Committee,
Dhanashree Hospital
for Dr. Vilas Bhailume
O & P Institutional Approved

Ethics committee for Dr.
Avavinash Phadnis
Sahyadri Clinical Approved
Research and
Development Center
Ethics committee for Dr.
Ketan Pai
Spandana Ethics Approved

Committee for Dr.
Mahesh Gowda


Problems Studied
Intervention / Type
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details 1.Male subjects be
stable, monogamo
for at least 6 mont
relationship for du
criteria for premat
specified in article
573. 4.Subject and
intercourse 2 time
consent and willin
Exclusion Criteria
Details 1.Previous events
ejaculation includi
surgery. 2.Subject
withdrawal. 3.Erec
except premature
partner, painful int
intercourse or othe
major psychiatric i
with history of epil
OR within last 14
oxidase inhibitor (
inhibitor (SSRI), s
serotonergic medi
atypical antipsych
ketoconazole, itra
nefazadone, nelfin
fluconazole, ampr
diltiazem, any vas
inhibitors, alcohol
form of therapy (P
ejaculation. 10.Pa
hematological/me
Mellitus) /respirato
/liver/kidney disea
orthostatic hypote
and any constitue
arrhythmia or any
history of bone ma
some other drug d
could alter the pha
study drug. 16.Pa
inclusion in the stu

Random Sequence
Concealment
Responder rate

1.Patient reported outcome measures for
premature ejaculation profile 2.Clinical Global
impression for change in premature ejaculation
3. Improvement in premature ejaculation (PE)
score


No Date Specified
Enrollment (India)
Enrollment (Global)
Estimated Duration of Years=
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary This Multicentric, double-blind, randomized, clinical trial will assess the effeicacy and s
Dapoxetine in premature ejaculation. Patient satisfing inclusion/exclusiuon criteria will
randomized to receive Dapoxetine or placebo approximately 1 to 3 hours prior to sexu
8 weeks. Subjects will be evaluated at baseline, after 4 and 8 weeks of therapy for
safety variables. Laboratory investigation will be done at baseline and after compl
CTRI Number CTRI/2011/07/001922 [Registered on: 27/07/2011] - Trial Registered Retrospectivel

Type of Study Biological
Public Title of Study To confirm efficacy of Kallikrein in improvement of neurological scores in patients of ac
stroke.
Scientific Title of A prospective, multicentric, double-blind, randomised, phase III clinical study to compa
Study efficacy and safety of intravenous Kallikrein versus placebo alongwith standard suppor
subjects of mild to moderate ischecmic stroke.

BSV/Kallikrein/2009
Investigator or overall Name Dr Uma Sundar
Trial Coordinator
Designation Professor
Affiliation Lokmanya Tilak M
Municipal Genera
Tilak Municipal Me
Hospital Sion Mum
Mumbai
MAHARASHTRA
400022
India
Phone
Fax
Email umasundar2@red
Details Contact De
Person (Scientific Name Dr Uma Sundar
Query)
Designation Professor
Affiliation Lokmanya Tilak M
Municipal Genera
Tilak Municipal Me
Hospital Sion Mum
Mumbai
MAHARASHTRA
400022
India
Phone
Fax
Email umasundar2@red
Details Contact D
Person (Public Query) Name Naju Turakhia
Designation General Manager-
Affiliation Bharat Serums an
Address
Thane (West)
Thane
MAHARASHTRA
400610
India
Phone 02261383409
Fax 02261383400
Email Naju.Turakhia@bh
Material Support > Bharat Serums and Vaccines Limited
Primary Sponsor
Name Bharat Serums an
Address 1st Floor, Building
Tatwagyan Vidyap
Maharashtra

Sponsor NIL
Recruitment India
Investigator
Dr Asha Shah B J Medical College
and Civil Hospital
Dr Sangeeta Ravat KEM Hospital and Seth

G.S Medical College
Dr Anita Basavaraj B.J.Medical College &

Sassoon General
Hospital
Dr MM Mehniratta GB Pant Hospital
Dr Amar Pazare KEM Hospital and Seth

G.S Medical College
Dr Anand Alurkar KEM Hospital Research
Center
Dr Nivedita Moulick Lokmanya Tilak

Municipal Medical
College & Lokmanya
Tilak Municipal General
Hospital
Dr Uma Sunder Lokmanya Tilak

Municipal Medical
College & Lokmanya
Hospital
Dr Neelima Chafekar N.D.M.V.P. Samaj

Medical College
Dr Santosh Kumar Sagar Hospital
Dr ST Malhan Seth V S Hospital
Dr Rahul Chakor T N Medical College &

B Y L Nair Hospital

Committee
Ethics Committee- KEM Approved
Hospital Research
Centre,Pune
and seth G S Medical
College, Mumbai
Ethics Committee- Approved
LTMMC & LTMGH,
Sion Mumbai
NDMVP Samaj Medical
College, Nashik
Sassoon General
Hospital
Ethics Committee- Civil Approved
Hospital, Ahmedabad
and seth G S Medical
College, Mumbai
Maulana Azad Medical
College and associated
hospitals

Maulana Azad Medical
College and associated
hospitals
Ethics Committee- T N Approved

Medical College & BYL
Nair Hospital
Ethics Committee-VS Approved
General hospital
Committee-Sagar
Hospital
Staff and research Approved
society-LTMMC &
LTMGH, Sion Mumbai

Approved/Obtained
Patients
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 1. Mild to moderat
48 hours after ons
11-20, moderate)<
inclusive) 3.
Exclusion Criteria
Details 1. Mean arterial bl
Age <18 or >70 ye
disease 5. Severe
survival during 3 m
potential 7. Peptic
bleed 8. Hematuri
neutropenia 10. E

Random Sequence
Method of Pre-numbered or coded identical Containers
Concealment
90 Day Mortality

Reduction in disability as measured by combined
Barthel Index & modified Rankin's scale.

Phase 3
Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary The study is a randomised, placebo controlled double-blind study to determine the effic
safety of Kallikrein as adjuvant therapy in treatment of mild to moderate ischemic strok
of 0.15 PNA o.d for 10 days. This study will be conducted in 8-10 centers in India. The
efficacy variables will be Neurologic improvement in NIHSS at day 5, day 11, day 30, d
day 90 from Day 1 of IP administration and 90 Day Mortality. The secondary efficacy v
be reduction in disability as measured by scores.

Type of Study Yoga & Naturopathy
Public Title of Study A randomized clinical trial for determining the efficacy of acupressure hand- and foot- r
addition to the anti-epileptic drugs (AEDs) compared with AEDs alone in the managem
patients suffering from intractable epilepsy
A randomized clinical trial for determining the efficacy of acupressure hand- and foot- r
addition to the anti-epileptic drugs (AEDs) compared with AEDs alone in the managem
patients suffering from intractable epilepsy
Scientific Title of Randomized clinical trial (RCT) of Reflexology therapy and usual drug treatment in the
Study management of intractable epilepsy
NIL
Investigator or overall Name Dr Mrs Krishna Da
Trial Coordinator
Designation Associate Profess
Affiliation All India Institute o
Address Department of Bio
New Delhi
DELHI
110029
India
Phone 01126593215
Fax 01126588663
Email drkrishnadalal@gm
Details Contact De
Person (Scientific Name Dr Mrs Krishna Da
Query)
Designation
Affiliation Associate Profess
Address Department of Bio
New Delhi
DELHI
110029
India
Phone 01126593215
Fax 01126588663
Details Contact D
Person (Public Query) Name Dr Manjari Tripath
Affiliation
New Delhi
DELHI
110029
India
Phone 01126594494
Fax 01126588663
Material Support > Monetary support: Central Council for Research in Yoga & Naturopathy, Department
Ministry of Health and Family Welfare, Government of India Material support: All India
Medical Sciences (AIIMS), New Delhi
Primary Sponsor
Name Central Council fo
Address Department of AY
Government of Ind
Type of Sponsor Government fundi

Sponsor Nil

Recruitment India
Investigator
Dr Mrs Krishna Dalal All India Institute of
Medical Sciences

Committee
Ethics committee, All Approved
India Institute of
Medical Sciences,
Ansari Nagar, New
Delhi 110 029

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details Patients of the age
had been included
arrangements to s
minimum three mo
consent proforma.
with at least a freq
more drugs in vari

more years. They
for surgery. They
doses of AEDs for
Exclusion Criteria
Details Any patient sufferi
has been exclude
tumor, encephaliti
kind of organ rese

Random Sequence
Concealment
1.Response of the patients to the therapy which
was measured in terms of improvement in
reducing seizure frequency (R)
2.No. of times seizures could be aborted during
aura
3.Quality of life in epilepsy

1.Abnormal features noted on the reflex areas
2.Any other associated symptom


15/07/2005
Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details K. Dalal, H. Kumar, K.G. Sharma, M. Tripathi, Elanchezhiyan D: An integrated manage
intractable epilepsy through reflexology and AEDs [abstract].Epilepsia, 50(Suppl. 11):1
Brief Summary This randomized clinical tri
addition to anti-epileptic drug
hypotheses of hand- and foo
that of vagus nerve stimulatio
body parts. All the subjects
department of Neurology, All
therapy and monitoring the th
AIIMS. The patients were su
non-responders of AEDs. Intra
suffering for a duration of more than 2 years, having

month and not responding to at least two anti-epileptic drugs (AEDs) on adequat
compliances. The trial could be completed in a group
assigned into two groups. Both control and active group
ongoing AEDs. The active group patients received hand- and foot -reflexology th
Amongst the types of epilepsy, the observed ones
to bilateral, convulsive seizures (involving tonic, clonic, or tonic and clonic com
which included partial seizure, general motor seizure and Lennox Gastaut Syndro
group patients, reflexology therapy was applied following a pre-determined ther
staged manner for an average duration of 2½ months
application compliances. Patients got the reflexology therapy applied by their c
desired places. During this training period, the patients and their caregivers were
reflexology laboratory for the following purposes: (i) to get the caregivers trained o
of reflexology therapy, (ii) to monitor the response of reflexology therapy, if ther
adverse effect, and (iii) to assess the quality assurance of the compliances. Patie
apply reflexology therapy on feet 2 times per day. Stimulations
vagus nerve, which were mapped on hands, were
patients/caregivers. This process was prescribed for 5 sessions per day with 15 s
seconds’ duration per session. The follow-up period of ea
therapy session administered and it was 1½ year irrespective of the group. Dur
period, the active group patients were asked to report at the laboratory at least o
the initial period of 2½ months; 2 times per months for a period of next 6 month
once in a month. Identical procedure was followed for the control group patients
follow-up period was 1 year 6 months, reflexology therapy was advised to be co
next 3years 6 months once per day with the hypothesis of avoiding regeneratio
foci. The primary outcome measures were to determine (i) the % of reduction in
at the end of the follow-up period with respect to the baseline; and (ii) improveme
life in epilepsy. The secondary outcomes were to detect the knee/lower limb pa
using visual analogue scale) and other associated symptoms
accordingly reflexology therapy was applied. Data records on seizure frequency w
the seizure diaries maintained by the caregivers.
was compared using Wilcoxon non-parametric test.
compared by two sided Wilcoxon Sign test. The quality of life was assessed by
instrument and the data was statistically analyzed using paired sample T-test. Th
frequency (number of seizures/month) in control group reduced from 18(range 2
2-700). These data for active group were 12(range 2-800) and 2(range 0-210) re
was 87.5% reduction in seizure frequency in the active group (p-value < 0.001).
scores of the quality o life in epilepsy for control and
f respectively. The respective post-therapy data were 49.07±6 and 65.4 ± 9. The
were statistically significant with p-value of 0.002. In the group of evolving to bila
seizures, the excellent response (75%?Response?100%) was among 76.9% pati
responses were found to be 54.5% and 50% among the dyscognitive seizures a
seizures respectively. Using reflexology techniques, it
dysfunctions by observing certain external features on
observed on the reflexology areas were tenderness, pigmentation, swelling, hollo
reoccurrence of corn or callus formation etc. (if it was not due to the misfit of foo
method, it was observed that 86% of the active group patients suffered from low
p-value<0.001. Post-therapy data revealed that 84% patients responded with 81%
severity (p-value<0.001). Other associated symptoms
were also improved with statistical significance (p-value<0.05). It was also reveal
changes in (i) hoarseness (1 patient), (ii) vomiting (1 patient) and (iii) voice chang
developed during the trial period in 4 patients of the active group. These observa
to the findings of directly implanted Vagus Nerve Stimulation
stimulation study group. The observations of this clinical trial brought out with th
acupressure hand- and foot- reflexology therapy together
patients with intractable epilepsy especially evolving
dyscognitive seizures. However, a multi-centre study is required to validate all th
this phase-II clinical trial.

Type of Study Yoga & Naturopathy
Public Title of Study A clinical trial to determine the effect of Reflexology therapy in addition to the pharmac
drugs for managing patients suffering from Diabetic Neuropathy
Scientific Title of Randomized Clinical Trial (RCT) on the effect of reflexology in the management of pati
Study from diabetic neuropathy: Case studies
I 483
Investigator or overall Name Dr Krishna Dalal
Trial Coordinator
Designation
Affiliation
Address Dept of Biophysics
New Delhi
DELHI
110029
India
Phone 01126593215
Fax 01126588663
Details Contact De
Person (Scientific Name Dr Krishna Dalal
Query)
Designation
Affiliation Head & Associate
Address Dept of Biophysics
New Delhi
DELHI
110029
India
Phone 01126593215
Fax 01126588663
Details Contact D
Person (Public Query) Name Dr (Mrs) Manjari T
Designation
Affiliation
New Delhi
DELHI
110029
India
Phone 01126594494
Fax 01126588663
Material Support > Monetary support: Indian Council of Medical Research (ICMR), New Delhi. Material s
India Institute of Medical Sciences (AIIMS), New Delhi
Primary Sponsor
Name Indian Council of M
Address Indian Council of M
New Delhi - 11002
Type of Sponsor Government fundi

Sponsor NIL
Recruitment India

Investigator
Dr Krishna Dalal Department of
Biophysics, All India
Sciences

Committee
Ethics Committee, All Approved
India Institute of
Medical Sciences New
Delhi 110 029

Intervention / Type
Comparator Agent
Inclusion Criteria
Age To 80.00 Day(s)
Gender Both
Details 1. Age group: any
were residents of
minimum duration
proper correspond
getting the informa
required for monit
4. Patients who ha
Patients with Bloo

120mg/decilitre(Fa
(post prandial) for
documented perip
Exclusion Criteria
Details 1. Patients non-re
stay in Delhi durin
months 2. Patients
foot amputation) d
sign informed con
over-neuropathy 5
malignancy, T.B.,

Random Sequence
Concealment
Neuropathy pain score measured by Visual
Analogue Scale (VAS) in the range of 0-10,
where 0 indicates no pain while 10 indicates
excruciating pain

Quality of Life in neuropathy as measured by
neuroQOL, responses on the reflex areas,
objective and subjective parameters. Abnormal
features recorded on the reflex areas: (i)
Tenderness (ii) Hollowness formation (iii)
Abnormal pigmentation (iv) Swelling (v) Corn
formation Objective parameters: (i) Blood sugar
level F & PP (ii) Glycosylated HbA1c (iii) Blood
pressure (iv) Frequency of urination (v) Nerve
conduction velocity (vi) Vibration sensitivity (vii)
Thermal sensitivity Subjective parameters
(standard questionnaire): (i) Numbness in the
legs/ feet (ii) Tingling sensation (iii) Difficulty in
walking (iv) Difficulty in standing (v) Burning
sensation


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

Trial (Global)
Trial (India)
Publication Details
Brief Summary A two armed, randomized, parallel

Reflexology in addition to the p
neuropathy associated with diab
patients selection criteria and the
were referred by the Outpatient D
Medical Sciences. A sample si
to 2009 for this trial. The intervention
Department of Biophysics. A group
group contains a sample size of 2
diabetes in years (median (ran
(0.5-8)]. The control group is co
11.21 and duration of diabetes in
years (median (range)) 6 (2-14
reductions in neuropathy in the st
Level of significance and 80% powe
station, Texas, USA) the sample
of 29 per group assuming 10% lost to
hypothesis that it would bring bac
functions, harmonize all the endo
diabetes. The working principle o
stimulations in the form of mome
able to rectify the internal organs fu
protocol was applied to treat the
by their own caregivers who got tra
period of 2 ½ -3 months was devoted
performances. Reflexology was
completion of training, therapy w
duration of the trial was 6 months fo
groups at the pre- and post- therapy
functions of the internal organs were
outcome measure of this trial wa
range of 0 to 10, where 0 indicates
outcome measures were the Qual
parameters recorded are (i) blood
blood pressure, (iv) frequency of uri
sensitivity and (vii) thermal sensit
questionnaire and these include
sensation, (iv) difficulty in walking an
statistically using students t- test,
(college station, Texas USA). Th
for the study and control group patie
improvements in Quality of Life in
There was marked improvement in
patients when compared with the c
(p-value < 0.001). The observatio
viz., tenderness, hollowness for
feet (if it is not due to unfit of the s
organs. This is an important obs
functions and hence the related ailment(s).

Type of Study Drug
Public Title of Study To evaluate the safety and efficacy of DAC HYP in subjects with Multiple Sclerosis who
completed treatment in study 205MS201 (SELECT).
Scientific Title of A double blind, multi center, extension study to evaluate the safety and efficacy of DAC
Study subjects with Multiple Sclerosis who have completed treatment in study 205MS201 (SE
2008-005559-46
205MS202
NCT00870740
Investigator or overall Name Nitya Pandita
Trial Coordinator
Designation Clinical Trial Lead
Affiliation
Floor, Sec 54, Go
Gurgaon
HARYANA
122002
India
Phone 01244572349
Fax 911244572370
Email nitya.pandita@bio
Details Contact De
Person (Scientific Name Dr Anjali Nagpal
Query)
Designation
Affiliation Senior Scientific A
Floor, Sec - 54, G
Gurgaon
HARYANA
122002
India
Phone 01244572343
Fax 01244572370
Email anjali.nagpal@bio
Details Contact D
Person (Public Query) Name Nitya Pandita
Designation Clinical Trial Lead
Affiliation
Floor, Sec 54, Go
Gurgaon
HARYANA
122002
India
Phone 01244572349
Fax 01244572370
Email nitya.pandita@bio
Material Support > Biogen Idec Innovation House 70 Norden Road, Maidenhead Berkshire SL4 6A
Primary Sponsor
Name Biogen Idec
Address
Type of Sponsor

Sponsor NIL
List of Countries
Recruitment India

Investigator
Dr. R.R. Agrawal Fortis Escorts Hospital
Dr. K. Venkateswarlu King George Hospital
Dr. A.K. Meena Nizam's Institute of

Medical Sciences
Dr. Pahari Ghosh Sri Aurobindo Seva

Kendra, Department of
Neurology,
Dr. A.K. Roy St Johns Medicial

Hospital

Committee
Ethics Committee of Sri Approved
Aurobindo Seva Kendra
Address: Sri Aurobindo
Seva Kendra, 1H
Gariahat Road (South),
Jodhpur Park,
Kolkata-700068, India
Institutional Ethical Approved

Review Board-
St.Johns Medical
College & Hospital
Address: Sarjapur
Road,
Banglore-560034, India
Committee, Fortis
Escorts Hospital
Address: Jawaharlal
Nehru Marg, Malviya
Nagar, Jaipur -302017,
India

Committee- Nizams
Sciences Address:
Panjagutta,
Hyderabad-500082,
India

Committee-Andhra
Medical College
Address: Andra Medical
College, King George H
ospital,Visakhapatnam-
530002, India
Seth G S Medical Approved

College & KEM
Hospital, Ward No
223/224/226, 2nd floor,
Old building, Acharya
Dhonde Marg, Parel,
Mumbai-400012, India

Intervention / Type
Intervention
Comparator Agent
Inclusion Criteria

Gender Both
Details 1. Ability to unders
provide signed an
use protected hea
national and local
subject from Study
been complia
the Investigator.<b
childbearing poten
during the study a
contraception for 4
For further details
Exclusion Criteria
Details 1. Subjects with a
Study 205MS201
including laborato
subject?s participa
re-review the subj
consider any disea
2. Any subject wh
Study 205MS201
evaluation of an a
Planned ongoing t
treatment for MS e
IFN-beta. 4. Curre
other than 205MS
requirements of th
(physical, mental,
to comply with the
opinion of the Inve
the subject unsuita

Random Sequence
Concealment
1. An assessment of safety and immunogenicity
of extended treatment with DAC HYP when
administered to MS subjects who have
completed 52 weeks of active therapy with DAC
HYP in Study 205MS201. 2. An assessment of
safety and immunogenicity during a 6-month
washout period from DAC HYP. 3. An
assessment of safety and immunogenicity during
re-initiation of therapy with DAC HYP after a
6-month washout period. 4. An assessment of
safety and immunogenicity of DAC HYP when
administered to MS subjects who previously
received placebo during study 205MS201

to assess the durability of the effect of DAC HYP
on MS disease activity as measured by brain
magnetic resonance imaging (MRI) scans and
clinical MS relapses.

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

Trial (Global)
Trial (India)
Publication Details
Brief Summary The rationale of this study is to extend DAC HYP therapy from study 205MS201 in ord
the long term safety, efficacy and immunogenicity of DAC HYP in multiple sclerosis. G
date, 221 patients have been rolled into this extension study out of the 621 patients wh
randomized in 205MS201 (SELECT) study. The first patient in India is expected to be J
Approximately 20 patients are expected to be recruited in India. The first patient is exp
enrolled in the study in India is by Jan 2011. The enrollment period in India will be from
April 2012.

Type of Study Drug
Public Title of Study Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset
A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and S
Examining Seizure Frequency of BGG492 Capsules administrated orally three times d
Adjunctive Treatment in Patients With Partial Onset Seizures
Scientific Title of A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and S
Study Examining Seizure Frequency of BGG492 Capsules administrated orally three times d
Adjunctive Treatment in Patients With Partial Onset Seizures

CBGG492A2207
NCT01147003
Trial Coordinator
Designation
Affiliation
Address Not Applicable
N/A
India
Phone
Fax
Email
Details Contact De
Person (Scientific Name Dr. Kamala Rai
Query)
Designation
Affiliation
Address Novartis Healthca
House, Shiv Saga
Mumbai
MAHARASHTRA
400 018
India
Phone 022 -24958533

Fax 022 -24954112
Email kamala.rai@novar
Details Contact D
Person (Public Query) Name Dr. Kamala Rai
Designation
Affiliation
House, Shiv Saga
Mumbai
MAHARASHTRA
400 018
India
Phone 022 -24958533

Fax 022 -24954112
Material Support > Novartis Pharma AG, Basel, Switzerland
Primary Sponsor
Name Novartis Health ca
Address Novartis India Lim
Road, Worli,Mumb

Sponsor NIL
Recruitment India
Investigator
Dr. Chandrashekhar Brain and Min
Meshram
Dr. Manoj Gulhane Curie Manavata Cancer

Centre
Dr. Satish Jain Indian Epilepsy Centre
Dr. Sudhir Kothari Poona Hospital and

Research Centre
Dr. Anshu Rohatgi Sir GangaRa
Dr. Ajit Roy St. John's Medical

College Hospital
Dr. Shamsher Dwivedi Vidyasagar Institute of
Mental Health and
Neuro-Sciences
(VIMHANS)

Committee
Central India Medical Submittted/Under

Research Ethics Review
Committee, Nagpur
Ethics Committee Submittted/Under
Poona Hospital and Review
Research Center, Pune
Ethics Committee Approved
VIMHANS
Independent Ethics Submittted/Under
Committee, Mumbai Review
Committee, New Delhi
Institutional Ethical Submittted/Under
Review Board, Review
Bangalore
Manavta Clinical Submittted/Under
Research Institute Review
Professional Ethics
Committee, Mumbai


Problems Studied
Intervention / Type
Intervention
Comparator Agent
Inclusion Criteria
Age From 18.00 Day(s)
Age To 65.00 Day(s)
Gender Both
Details 1.Male and female
Are of greater than
a diagnosis of epil
screening) with pa
generalized seizur
Against Epile
1981) Appen
established by clin
that is consistent w
had either a comp
imaging (MRI)<br/
out progressive ne
disease, Parkinso
physical exa
diseases should h
procedure; If
5 years, then a MR
period and the res
above criterion pri
uncontrolled partia
least two diff
prior to screening
Must have at leas
seizures with moto
partial seizures wi
of these types) du
the 4 weeks
(retrospective and
seizure free period
8. Must be receivi
and 9) with 1 or a<
below: 8.1 N
8 weeks prior to
No change in med
to randomiza
nerve stimulation
benzodiazepine tr
frequency fo
e.g. epilepsy, anxi
AED Note: T
in exclusion criteri
vagal nerve stimu
least 22 wee
may not have bee
randomization<br/
may be included.
partial seizures m
than or equal to 1
stable doses (con
non-AED con
of taking his or he
direct questio
knowledge of prio
under the investig
and willing to mak
able to recor
or have a caregive
report the events f
consent before an
Exclusion Criteria
Details Any of the followin
1.1 Presence of o
1.2 History of psyc
1.3 Absences, my
generalized epilep
1.4 Previous histo
1.5 History of statu
seizures cannot
be counted accord
within 52
weeks prior to ran
1.6 Only seizures
52 weeks prior to
randomization
2. Have been trea
2.1 Felbamate, un
than or equal to 2
2.2 Vigabatrin dur
2.3 Monoamine ox
PDF of Trial
CTRI Website URL - http://ctri.nic.in
and narcotic
analgesics such as e.g. morphine, oxycodone, fentanyl, codeine
within 8 weeks
prior to randomization
2.4 Barbiturates (except for seizure control) within 8 weeks prior to
randomization
2.5 Intermittent benzodiazepines two or more times in a 4-week
period prior to
randomization (1-2 doses over a 24-hr period will be considered
one-time use)
2.6 L-dopa formulations
2.7 Use of concomitant medication that are potential inhibitors of
OATP transporters
e.g. cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior
to
randomization
Known history of hypersensitivity to the study drug or to drugs of
similar chemical classes
(e.g. sulfonamides)
4. Have had multiple drug allergies or one or more severe drug
reactions to an AED,
including dermatological reactions, (e.g. Stevens-Johnson syndrome,
hematological, or
organ toxicity reactions) a rash would not be exclusionary
5. Use of other investigational drugs within 12 weeks prior to
randomization
6. Pregnant or nursing (lactating) women, where pregnancy is
defined as the state of a
female after conception and until the termination of gestation,
confirmed by a negative
hCG laboratory test (greater than or equal to 5mIU per mL) at
screening and a negative urine test immediately prior
to administering the first dose of study medication
7. Women of childbearing potential, defined as all women
physiologically capable of
becoming pregnant including women whose partners have been
sterilized by vasectomy or
other means, UNLESS they are
• Women whose career, lifestyle, or sexual orientation precludes
intercourse with a male
partner
• Using two birth control methods. The two methods can be a double
barrier method or
a barrier method in combination with a hormonal method
Adequate barrier methods of contraception include diaphragm,
condom (by the
partner), intrauterine device (copper or hormonal), sponge or
spermicide. Hormonal
contraceptives include any marketed contraceptive agent that
includes an estrogen
and or a progestational agent.
Reliable contraception should be started at screening, maintained
throughout the study
and for 2 week after study drug discontinuation.
Women are considered post menopausal and not of child bearing
potential if they have
had 12 months of natural (spontaneous) amenorrhea with an
appropriate clinical profile
(e.g. age appropriate, history of vasomotor symptoms) or six months
of spontaneous
amenorrhea with serum FSH levels greater than 40 mIU per mL [for
US only: and estra
or have had surgic
hysterectomy) at l
weeks ago. In the
reproductive statu
woman has been
is she considered
of child bearing po
8. Any of the follow
8.1 Myocardial inf
stroke) within 26
weeks prior to scr
8.2 History of or u
8.3 Hypertension
systolic blood
pressure greater t
pressure greater t
baseline or if re-as
limits at prior
to initial dosing on

Random Sequence
Concealment
Seizure counts, documenting the percent change
in seizure frequency of BGG492 in the
maintenance period.

1) Responder rate: analysis of patients with a
50% or greater reduction in seizure frequency of
BGG492 during the maintenance period.


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

Trial (Global)
Trial (India)
Publication Details
Brief Summary Target number of patients is 35. Planned FPFV from India is 23 Sep 2010.

Type of Study Drug
Public Title of Study A clinical Trial in Men with Erectile Dysfunction. Clinical trial is to study efficacy, safety
tolerability of Vardenafil Tablets in comparison to Tadalafil Tablets (reference product).
Scientific Title of A comparative, randomized, single blind, parallel group, and non-crossover, multicentr
Study study of Vardenafil Tablets Vs Tadalafil Tablets in Men with Erectile Dysfunction.
APL/CT/10/006
Investigator or overall Name Dr Shailesh Singh
Trial Coordinator
Designation Associate Vice Pr
Affiliation Ajanta Pharma Ltd
Address Ajanta Pharma Ltd
Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India
Phone 022-66062112
Fax 022-66062100
Email shaileshs@ajanta
Details Contact De
Person (Scientific Name Dr Shailesh Singh
Query)
Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India
Phone 022-66062112
Fax 022-66062100
Details Contact D
Person (Public Query) Name Dr Shailesh Singh
Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India
Phone 022-66062112
Fax 022-66062100
Material Support > Ajanta Pharma Ltd.
Primary Sponsor
Name Ajanta Pharma Ltd
Kandivli (West) M

Sponsor NIL

Recruitment India
Investigator
Dr Milind Kirloskar Dr. Milind Kirloskar?s
Clinic
Dr. K. P. Mishra Dr. Mishra's Clinic
Dr. S. B. Gaikwad Gaikwad Nurs
Dr. Devendra Patil Ishaan Urology Centre

Committee
Jagruti Independent Approved
Ethics Committee
Bandra Mumbai 400050
Ethics Committee
Ethics Committee
Ethics Committee

Patients
Type
Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Male
Details 1.Availability of su
adhere to protoco
consent. 2.P
Dysfunction (Inabi
erection, Painful e
Exclusion Criteria
Details 1. Male < 18 years
the study drug or r
of gastrointestinal
known to interfere
excretion of comm
anatomical deform
significant illness d
Participation in a c
days proceeding d
opinion of the inve
the study.

Random Sequence
Method of Pharmacy-controlled Randomization
Concealment
International Index of Erectile Function (IIEF ?5)
questionnaire
Sexual Encounter Profile (SEP) questions


Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=21

Trial (Global)
Trial (India)
Brief Summary This study is a comparative, randomized, single blind, parallel group, and non-crossov
multicentric, clinical study of Vardenafil Tablets Vs Tadalafil Tablets in 200 Men with E
Dysfunction. The study was started on 27 september 2010.
The primary outcome will be measured by International Index of Erectile Function (IIEF
questionnaire and secondary outcome measure will be assessed by Sexual Encounter
(SEP) questions at day 1, week 4, week 8 and week 12.

Type of Study Drug
Study Design Other
Public Title of Study Pregabalin Trial In HIV Neuropathic Pain
Scientific Title of An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pa
Study With HIV Neuropathy
A0081251
NCT01145417
Investigator or overall Name Swapnali Raut
Trial Coordinator
Mumbai, MAHARA
Floor, Platina, Plo
Bandra (E), Mumb
Mumbai
MAHARASHTRA
400 102
India
Phone 91-9821415224
Fax 91-022-26525993
Details Contact De
Person (Scientific Name Swapnali Raut
Query)
Mumbai, MAHARA
Floor, Platina, Plo
Bandra (E), Mumb
Mumbai
MAHARASHTRA
400 102
India
Phone 91-9821415224
Fax 91-022-26525993
Details Contact D
Person (Public Query) Name Swapnali Raut
Mumbai, MAHARA
Floor, Platina, Plo
Bandra (E), Mumb
Mumbai
MAHARASHTRA
400 102
India
Phone 91-9821415224
Fax 91-022-26525993
Material Support > Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 40
Primary Sponsor
Name Pfizer Limited
Address Pfizer Centre, Pat
400 102, India

Sponsor Nil
Recruitment Colombia
Czech Republic
Dominican Republic
India
Other
Peru
Poland
South Africa
Thailand
United States of America

Investigator
centre
Dr. Atul Patel Infectious Disease

Clinic
Dr. Janak Keshavlal Jaslok Hospital and

Maniar Research Centre
Dr Srinivas Kulkarni Mahavir Hospital and
Research Centre
Dr Usha Kant Misra Sanjay Gandhi

Postgraduate Institute
of Medical Sciences,
Dr. Lily Rodrigues Surakshaka

Dr. Nagalingeswaran YR Gaitonde Centre for

Kumarasamy AIDS Research and
Education

Committee
Heart Care Clinic
Ethics committee, Approved
Jaslok Hospital and
Research Centre
Committee for
Biomedical research,
Bhagwan Mahavir
Medical Research
Centre
Mangeshkar Hospital
and Research centre
Sanjay Gandhi Post Approved

Graduate Institute of
Medical Sciences
(SGPGI)
Surakshaka Institutional Approved

Ethics Committee
YRG Care Institutional Approved
review Board

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details 1. Subjects who p
trial and complete
Subjects with pain
in treatment based
who had acceptab
Note: There is no
Exclusion Criteria
Details 1. Clinically signifi
the investigator, w
includes, for exam
hepatic, renal, res
cardiovascular dis
disease, active inf
psychiatric illness,
severe acute or ch
abnormality that m
participation or inv
with the interpreta
investigator, would
study. 3. Active Ac
defining Opportun

Random Sequence
Concealment
Spontaneous Adverse Event Monitoring

Work Productivity and Activity Impairment
Questionnaire (WPAI:SHP)
Short Form 36 Health Survey (SF-36).
Pain VAS for the prior week
Patient Global Impression of Change (PGIC).
Sheehan-Suicidality Tracking Scale (S-STS).
Patient Health Questionnaire-8 (PHQ-8).


Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=7
Months=6
Days=7
Trial (Global)
Trial (India)
Brief Summary This is an open label 6 months extension of study A0081244 (CTRI2010/091/0
evaluate the safety of Pregabalin in subjects HIV Neuropathic Pain Subject co
Visit 9 or EOS for A0081244 study will be rolled over in the A0081251 extensi
During this period they will receive treatment 75 mg to 300 mg BID Pregabalin
Following completion of the A0081244 double-blind trial, subjects who meet a
and no exclusion criteria and have completed at least Visit 9 of study A008124
option of initiating treatment with pregabalin under open-label conditions for 6
Subjects who meet all eligibility criteria will initiate open-label treatment at 150
mg BID). Further adjustments of total daily dose within the dose range 150-60
(BID) are permitted throughout the study based on subjects’ individual respon
tolerability. Subjects will return to the study site for efficacy and safety assess
Months 1, 2, 3, 4, 5, 6 (Visits 3, 5, 6, 7, 8, and 9). There will also be a phone v
following Visit 1 and 2 weeks following Visit 3 to assess for adverse events an
dose adjustment. During Visit 9, subjects will initiate a 1-week taper and return
visit one week later (Visit 10).

Type of Study Drug
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory
Seizures
Public Title of Study Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory
Seizures
Scientific Title of A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Asses
Study Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With
Partial Onset Seizures

CBGG492A2211
NCT01167335
Trial Coordinator
Designation
Affiliation
Address Not Applicable
N/A
India
Phone
Fax
Email
Details Contact De
Person (Scientific Name Dr. Kamala Rai
Query)
Designation
Affiliation
House, Shiv Saga
Mumbai
MAHARASHTRA
400 018
India
Phone 022 -24958533

Fax 022 -24954112
Details Contact D
Person (Public Query) Name Dr. Kamala Rai
Designation
Affiliation
House, Shiv Saga
Mumbai
MAHARASHTRA
400 018
India
Phone 022 -24958533
Fax 022 -24954112
Material Support > Novartis Pharma AG, Basel, Switzerland
Primary Sponsor
Name Novartis Health ca
Address Sandoz House, 5t
Worli, Mumbai 400

Sponsor NIL
Recruitment India
Investigator
Dr. J M K Murthy CARE Hospital
Dr. Monika Singla Dayanand Medical

College & Hospital

Center
Dr. Manmohan G. B. Pant Hospital

Mehdiratta
Dr. Sita Jayalakshmi Krishna Institute of

Medical Sciences
Dr. Rangasetty M S Ramaiah Memorial
Srinivasa Hospital ,
Dr. Shankar Nellikunja Mallikatta Ne
Dr. Bhawna Sharma Sawai Man Sing

Hospital

Committee
Care Foundation, Submittted/Under
Hyderabad Review
Dinanath Mangeshkar Submittted/Under
Hospital & Research Review
Center, Pune
Drug Trial Ethics Submittted/Under
Committee, Dayanand Review
Medical College and
Hospital, Ludhiana
Ethical Review Board, Submittted/Under

Bangalore Review
ETHICS Commitee, Submittted/Under
RMRS, SMS Review
HOSPITAL (COLLEGE
DEVELOPMENT
FUND) JAIPUR

Committee, Krishna
Sciences Limited,
Secunderabad
Mallikatta Ethical Submittted/Under

Committee, Mangalore Review
MAMC Society for Submittted/Under
Promotion of Medical Review
Research, New Delhi

Problems Studied
Intervention / Type
Intervention
Comparator Agent
Inclusion Criteria
Age From 18.00 Day(s)
Age To 65.00 Day(s)
Gender Both
Details Male and female o
Weight of greater
diagnosis of epilep
partial seizures combinatio
period and the 4 w
period 5. Hav
preceding random
iGluR3 antibodies
three standard de
as cutoff value.
treatment (see inc
maximum of 2 AE
change in medica
to randomiza
Oxcarbazepine, P
Lamotrigine, Leve
Zonisamide, Gaba
if treatment h
years. 8.2 No
12 weeks prior to<
Primidone 8.
1 AED. If using a v
been implanted fo
Stimulator parame
weeks prior t
treatment (no cha
12 weeks prior to
anxiety, or sl
Note: The use of i
exclusion criteria<
had either a comp
imaging (MRI)<br/
out progressive ne
disease, Parkinso
changes sug
occurred since the
CT or MRI within t
performed during
reviewed for comp
randomization<br/
may be included.
partial seizures m
than or equal to 1
stable doses (con
AED concom
his/her medication
questioning of pat
prior compliance<
investigators care
to make themselv
to record sei
have a caregiver (
report the events f
consent before an
Exclusion Criteria
Details * Presence of only
psychogenic seizu
context of primary
Lennox-Gastaut s
Status epilepticus
the investigator, o

Random Sequence
Concealment
Seizure counts, documenting the percent
change in seizure frequency of BGG492 in the
maintenance period.

Safety and tolerability of BGG492 compared to
placebo evaluated by continuous adverse event
monitoring and assessment of vital signs and
ECGs at each visit and laboratory assessments
every 2 to 4 weeks
Pharmacokinetic profile of BGG492 including

plasma concentrations of BGG492 at each dose
level and derived variables including AUC (area
under the curve), Cmax (maximum plasma
concentration), Tmax (time to maximum
concentration), T1/2 (half life.)
Responder rate: analysis of patients with a 50%

or greater reduction in seizure frequency of
BGG492 during the maintenance period.


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0
Years=1
Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary Target number of patients from India is 30. Planned FPFV from India is 11th Novembe
patients screened from India

Last Modified On
Type of Trial
Type of Study
Public Title of Study Efficacy and safety of Fixed Dose Combination of Dexketoprofen Trometamol and Dicy
Hydrochloride Injection
Scientific Title of Clinical trial to assess the efficacy and safety of Fixed Dose Combination of Dexketopr
Study Trometamol and Dicyclomine Hydrochloride Injection in the treatment of Acute Colicky
EPL/2010/DD/01
Investigator or overall Name Dr. Onkar Swami,
Trial Coordinator
Designation
Affiliation
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019
Details Contact De
Person (Scientific Name Dr. Onkar Swami,
Query)
Designation
Affiliation
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019
Details Contact D
Person (Public Query) Name Dr. Onkar Swami,
Designation
Affiliation
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019
Material Support > Emcure Pharmaceuticals Ltd. Pune
Primary Sponsor
Name Emcure Pharmace
Address
Type of Sponsor

Sponsor NONE
Recruitment India
Investigator
Dr. Sudhir Kumar Abhinav Multispeciality
Bhatnagar, MD Hospital
Dr. S. Balamurugan, Chest Research Centre

MBBS, DTCD, DNB
Dr. P. T. Jamdade, MS Department of Surgery
Dr. Vijay V. Kamat, MS, Department of Surgery

DNB KIMS
Dr. Ashish Badadare, Giridhar Clinic

MD (Med)
Dr. Rajeev C. Naik, MD Ketki Hospital

(Med)
Dr. Dinesh S. Oswal Modern Stone Care &

Urology Research
Centre
Dr. Samadhan N. Pawana Hospital

Kshirsagar, MBBS, MS
Dr. Jagdish V. Keny, Prabha Vithal Clinic
MBBS, AFIH, DHA
Dr. Rajesh Enadle, MD Prabhavati

and Reserch Centre
Dr. Indraneel Basu, MD Ram Krishna Mission

Hospital
Dr. Abhay D. Mahajan, Sai Urology Hospital

MS, MCh (Uro)
Dr. Shantanu Sengupta Hospital and

Sengupta, MD, DNB Research Institute
Dr. Samadhan N. Sevadham Hospital

Kshirsagar, MBBS, MS
Dr. Ashwin Porwal, Sharada Clinic

DNB
Dr. Subhash S. Erram, Sharada Clinic, Erram

MS, FICS Hospital
Dr. P. S. Karamarkar, Shashwat Hospital

MS, DNB
Dr. Shrihari Dhore Patil, Shree Hospital
MS, FICS, FAIS
Dr. Dhiren N. Sheth, Surgical Hospital

MS
Dr. Ravindra S. Walvekar Hospital

Walvekar, MS

Committee
Independant Ethics Approved No Date Specified

Committee,
Dhanashree Hospital,
Pune for Dr. Abhay D.
Mahajan

Committee,
Pune for Dr. Ashish
Badadare, MD (Med)

Committee,
Pune for Dr. Ashwin
Porwal

Committee,
Pune for Dr. Dinesh S.
Oswal

Committee,
Pune for Dr. Dr. Dhiren
N. Sheth, MS
Committee,
Pune for Dr. Indraneel
Basu

Committee,
Pune for Dr. Jagdish
Keny

Committee,
Pune for Dr. P. S.
Karamarkar, MS, DNB

Committee,
Pune for Dr. Rajeev C.
Naik, MD (Med)

Committee,
Pune for Dr. Rajesh
Enadle

Committee,
Pune for Dr. Ravindra
S. Walvekar, MS

Committee,
Pune for Dr. S.

Balamurugan
Independant Ethics Approved
Committee,
Pune for Dr. Samadhan
N. Kshirsagar, MBBS,
MS
Committee,
Pune for Dr. Samadhan
N. Kshirsagar, MBBS,
MS

Committee,
Pune for Dr. Shantanu
Sengupta, MD, DNB

Committee,
Pune for Dr. Shrihari
Dhorepatil

Committee,
Pune for Dr. Subhash
Erram

Committee,
Pune for Dr. Sudhir
Kumar Bhatnagar, MD

Committee,
Pune for Dr. Vijay
Kamath

Committee, Dr.
Shankarrao Chavan
Govt. Medical College
Nanded

Problems Studied
Intervention / Type
Comparator Agent
Inclusion Criteria
Age From
Age To
Gender
Details 1.Male and female
presenting with ac
abdomen or genita
Scale (VAS &amp
informed consent
Exclusion Criteria
Details 1.Patients with kn
/or history of any d
anesthetic medica
therapy known to
suspected gastroi
chronic dyspepsia
Crohn?s disease o
bronchial asthma
moderate to sever
ml/min.) or severe
15) 7.Patients with
disorders 8.Any co
alcoholism 10.Pat
11.Patients with k
glaucoma 13.Patie
hematological / m
diabetes mellitus)
cardiovascular dis
child bearing pote
contraception. 15.
investigator, does

Random Sequence
Concealment
Proportion of patients having ≥ 50 % pain
relief within 8 hours

1.Time of onset of significant decrease in VAS
scores 2.Comparison of sum analogue of pain
intensity difference (SAPID) 3.Comparison of
pain intensity difference (PID) at 8th hour of
injection 4.Patient?s clinical global impression for
change in pain 5.Percent of the subjects
experiencing any drug related adverse event as
evaluated and recorded by the investigator
6.Subject?s global assessment about the
tolerability of the drug 7.Physician?s global
assessment about the tolerability of the drug


Enrollment (India)
Enrollment (Global)
Estimated Duration of Years=
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary This multicentric, randomized, open label, comparative clinical trial is planned to comp
efficacy and safety of FDC of dexketoprofen trometamol 50 mg and dicyclomine hydro
mg IM injection with FDC of diclofenac and dicyclomine hydrochloride IM injection in pa
acute renal colic. Subjects satisfying inclusion and exclusion criteria will be randomized
receive FDC of dexketoprofen trometamol 50 mg and dicyclomine hydrochloride 20 mg
or FDC of diclofenac and dicyclomine hydrochloride IM injection. Subjects will be evalu
intensity on visual analogue scale (VAS) just before drug administration of study medic
VAS) and then at the intervals of 1, 2, 4, 6 and 8 hours after the injection. Primary and
efficacy variables and safety variables will be noted and analyzed.

Interventional
Type of Study Drug
Study Design Non-randomized, Active Controlled Trial
Public Title of Study A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of T
(TPM)
Scientific Title of A Conversion Study to Determine the Relative Bioavailability of TPM CR vs TPM IR in
Study Epilepsy
538P108
CT/Drugs/347/10
NCT01114854
Investigator or overall Name Jennifer Stocks-A
Trial Coordinator
Designation
Affiliation
Address Supernus Pharma
Not Applicable
N/A
201307
India
Phone 00-301- 838-2520

Fax 00-301- 838-2504
Email
Details Contact De
Person (Scientific Name Dr. Shiral Raina
Query)
Designation
Affiliation
Address Jubilant Clinsys Lt
Not Applicable
N/A
201307
India
Phone 0120 4364004

Fax 0120 4364001
Email shirali_raina@clin
Details Contact D
Person (Public Query) Name Mr. Ashish Dasgu
Designation
Affiliation
Address Jubilant Clinsys Lt
Not Applicable
N/A
201307
India
Phone 0120 4364001

Fax 0120 4364001
Email ashish_dasgupta@
Material Support > Supernus Pharmaceuticals, Inc. 1550 East Gude Drive Rockville, MD 20850 United
Primary Sponsor
Name Supernus Pharma
MD 20850 United
Address
Type of Sponsor

Sponsor NIL
Recruitment India
Investigator
Dr Ramananda Brain Mind Behaviour
Satapathy Neurosciences
Research Institute
Dr P K Sethi Sir Ganga Ram

Hospital Department of
Neurology,
Dr Pahari Ghosh Sri Aurobindo Seva

Kendra
Dr Vikram Sharma St Theresa?s Hospital

Department of
Neurology,
Dr Ajit Kumar Roy St. John's Medical


Committee
Ethics Committee of Sri Submittted/Under
Aurobindo Seva Kendra Review
Ethics Committee St. Submittted/Under
Theresa?s Hospital Review
Institutional Ethical Submittted/Under
Review Board Review
Committee - King
George Hospital
Sir Ganga Ram Submittted/Under
Hospital Ethics Review
Committee

Intervention / Type
Comparator Agent
Inclusion Criteria
Gender Both
Details Inclusion criteria <
female subjects di
seizures and rece
200, 250, 300, 350
at least four week
any other anti-epil
for at least two we
voluntarily provide
study. 
use an effective m
weeks prior to stu
using such precau
Exclusion Criteria
Details Exclusion Criteria:
history of generali
An average seizur
or recent history o
nervous system (C
degenerative neur
progressive that m
Diagnosis or an el
seizure disorders
tonic-clonic seizur
criteria for current
and Statistical Ma
Revision, for singl
months prior to Sc
active suicidal tho
within the last two
General health ex
significant, chronic
contraindicating a
gastrointestinal, e
hematological, imm
subject. b) History
electrocardiogram
uncontrolled hype
Investigator, may
potential hepatic f
alanine aminotran
(ULN), aspartate a
>1.5 times ULN. d
function defined b
General exclusion
dependence within
pregnant or lactati
participation in an
first dose of SM.

Random Sequence
Method of Pre-numbered or coded identical Containers
Concealment
Bioavailability of TPM CR after 14 days of repeat
dosing will be assessed relative to TPM IR after
14 days of repeat dosing based on the 90%
confidence intervals of the ratio of the
dose-normalized geometric least-squares means
(LSMs) derived from the analyses on the
ln-transformed PK parameters AUC0-24 , Cmax,
and Cmin.

1. Bioavailability of TPM CR immediately
following the switch from TPM IR to TPM CR will
be assessed relative to TPM IR after 14 days of
repeat dosing of TPM IR based on the 90%
dose-normalized geometric LSMs derived from
the analyses on the ln-transformed PK
parameters AUC0-24 , Cmax, and Cmin 2.
Bioavailability of TPM CR after 14 days of repeat
dosing will be assessed relative to TPM IR after
14 days of repeat dosing based on the 90%
dose-normalized geometric LSMs derived from
the analyses on the ln-transformed partial AUC
from time 0 to time p (AUC0-p), where p equals
0.5, 1, 2, 3, 4, 6, 8, 12 (or 11.75), 16, 20, and 24
hours post dose. 3. The following
pharmacokinetic parameters will be estimated at
steady state and following switch: a. For both
TPM CR and TPM IR: AUC0-24, Cavg, Cmax,
Cmin, Ctrough, Tmax and FL%. b. For TPM IR
only: Tmax,0-12 and Tmax,12-24. 4. The rates of
treatment related discontinuation for the two
formulations will be compared. 5. Treatment
preference will be assessed


No Date Specified
Enrollment (India)
Enrollment (Global)

Trial Months=6
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary This study is a multi-center, two-treatment conversion study determining the relative bi
of Topiramate controlled release formulation vs Topiramate immediate release 200, 25
or 400 mg/day in subjects with epilepsy in 28 Indian patients out of 72 global patients w
that will be conducted in five centers in India and twelve in USA. The primary endpoint
bioavailability of TPM CR after 14 days of repeat dosing will be assessed relative to TP
days of repeat dosing based on the 90% confidence intervals of the ratio of the dose-n
geometric least-squares means (LSMs) derived from the analyses on the ln-transforme
parameters AUC0-24 , Cmax, and Cmin. Two weeks after enrollment, samples will be
analysis of the current Topiramate immediate release therapy. Subjects will then be sw
equivalent dose of Topiramate controlled release (TPM CR) given once daily (QD) and
will be drawn following the first dose. After two weeks, samples will be drawn for stead
analysis of the TPM CR therapy. The total daily dose (TDD) the subject is receiving at
will remain the same throughout the study. Anticipated date of enrollment in India is 15
PDF of Trial
un, 08 Jan 2023 04:47:04 GMT)
nj Diclofenac 75mg/mL given as an IV

usion in the management of postoperative
uating the Efficacy and Tolerability of

jection versus Diclofenac Sodium
ost Operative Pain.
Identifier
Protocol Number
Details of Principal Investigator
Dr Sanjay Maroo
General Manager
Troikaa Pharmaceuticals Limited
Medical Services Department, Troikaa Pharmaceuticals Limited
Commerce House- 1, Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India
07926856242
079-26856246
sanjaymaroo@troikaapharma.com
Details Contact Person (Scientific Query)
Dr Sanjay maroo
General Manager
Ahmadabad
GUJARAT
380 054
India
07926856242
07926856246
Details Contact Person (Public Query)
Dr sanjay maroo
General Manager
Ahmadabad
GUJARAT
380 054
page 1 / 5
PDF of Trial
India
07926856242
07926856246
Source of Monetary or Material Support
Primary Sponsor Details

Commerce House – 1, Satya Marg Opp. Rajvansh Apartment,
Bodakdev Ahmedabad – 380 054.
Pharmaceutical industry-Indian
Address
Name of Site Site Address Phone/Fax/Email
Chhatrapati Shahuji Professor & Head, +91-522-2257450

Maharaj Medical Department of Anesthe jaishri.bogra@gmail.co
University, U. P. siology,Chhatrapati m
Shahuji Maharaj
Medical
University-226003
Lucknow
UTTAR PRADESH
Command Hospital Head, Department of +91-522-2296542

(CC) Anaesthesia,-226002 tvspmurthy@yahoo.co
Lucknow m
UTTAR PRADESH
Dr. D. Y. Patil Medical Professor, Department +91-22-26842866
College of Anesthesia,Sector 5, shubha.mohite@gmail.
Nerul-400706 com
Mumbai
MAHARASHTRA
Fortis Hospital Head, Department of +91-9810853355

Anesthesia, Pain pn_kakar@hotmail.com
Management and
Peri-operative
Care,Shalimar
Bagh-110088
New Delhi
DELHI
Padmashree Dr. D. Y. Mahesh +91-9767280200

Patil Medical College Nagar,Pimpri-411018 bmsubnis@gmail.com
Pune
MAHARASHTRA
R G Stone Urology & F-12, East of Kailash, 01140721000

Laparoscopy Hospital New Delhi-110065 drvarshney@rghospital.
New Delhi com
DELHI
Seth GS Medical Associate Professor, +91-22-24136051

College & KEM Hospital Department of Anaesth preranashroff@kem.ed
esiology,Acharya u
Donde Marg, Parel-400
page 2 / 5
PDF of Trial
012
Mumbai
MAHARASHTRA
Approval Status Date of Approval Is Independent Ethics

Committee?
Approved 13/02/2010 Yes
Approved 19/04/2010 No
Date
23/10/2009
Condition
Post Operative Pain
Name Details
Injection diclofenac sodium 75 75mg to be injected
mg/ 1 ml (Mfg. by Troikaa intravenously as IV bolus over a
Pharmaceuticals Ltd.) period of 5- 60 seconds.
Injection diclofenac sodium 75 75mg should be infused
mg/ 3 ml (Mfg. by Novartis) continuously over a period of 30
minutes.
Inclusion Criteria
18.00 Year(s)
60.00 Year(s)
Both
1Patients in the age group of 18 to 60 years 2Patients of both
sexes 3Patients undergoing elective day surgery with
moderate to severe pain 4Patients with moderate to severe
pain at baseline (VAS score greater than or equal to 4)
Exclusion Criteria
1. Patients below 18 years and above 60 years of age
2. Patients with compromised renal function
page 3 / 5
PDF of Trial
3. Pregnant and lactating women
4. Patients with history of bronchial asthma, peptic ulceration,
bronchitis
5. Patients with coagulation disorders (esp. bleeding disorders)
6. Mentally retarded patients
7. Unwilling patients
8. Patients with known hypersensitivity to propylene glycol,
diclofenac sodium any other NSAIDs or any component of either of
the study formulations
9. Patients with mild baseline pain (VAS < 4)
ome Timepoints
1. The time to onset of analgesia of the study
medication will be assessed and noted after
asking and ascertaining from the patient.
2. Intensity of post operative pain would be
assessed by visual analogue scale (VAS)
assessed by patients at 0 (Basal), 15 minutes,
30 minutes, 45 minutes, 1, 2, 4, 8 and 12 hours.
ome Timepoints
15 minutes After the Dose Given
At the End of Study
15 minutes, 1, 4, 8 and 12 Hous After the Dose
Given
Upto 12 Hours After the Dose Given
Upto 12 Hours After the Dose Given
of pharmaceutical sciences and research,

12/36%20Vol.%204,%20Issue%2012,%20
pdf
e pain is diclofenac. Diclofenac sodium is
novel formulation of diclofenac has been
ml of the solvent. The aim of this study is to
he 1 ml diclofenac formulation versus the 3
e pain is diclofenac. Diclofenac sodium is
novel formulation of diclofenac has been
ml of the solvent. The aim of this study is to
he 1 ml diclofenac formulation versus the 3
page 4 / 5
PDF of Trial
operative pain.
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:47:26 GMT)
rstitial Cystitis/ Painful Bladder Syndrome

olled, Dose Ranging Study Evaluating The
Of Moderate To Severe Pain Associated
BS)
Identifier
Protocol Number
ClinicalTrials.gov
Swapnali Raut
Compliance Oversight Lead
Representing Pfizer Limited
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,
Mumbai, MAHARASHTRA, 400 102, India C/O Wyeth Limited, 6th
Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex,
Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400 102
India
91-9821415224
91-022-26525993
Swapnali.raut@pfizer.com
Swapnali Raut
Mumbai
MAHARASHTRA
400 102
India
91-9821415224
91-022-26525993
Swapnali Raut
page 1 / 5
PDF of Trial

Mumbai
MAHARASHTRA
400 102
India
91-9821415224
91-022-26525993
Jogeshwari West, Mumbai 400 102 India
Pfizer Limited
Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai
400 102, India
Pharmaceutical industry-Global
Address
NIL
Kidney and Urology 2nd Floor, Shantam 9824022035,

Hospital,Interstitial Complex, ,Gurukul 079-27497083
Cystitis Center Road, Memnagar, 079-40054104
-380052 nagendraad1@yahoo.c
Ahmadabad om
GUJARAT
Sterling Hospital Road, Memnagar, ,-380 052 (+91) - 079 26469846,

Ahmadabad (+91) - 98244 65767
GUJARAT 079 - 40011156
pkandarp@hotmail.com

Committee?
page 2 / 5
PDF of Trial
Date
28/04/2010
Condition
Cystitis, Interstitial
Name Details
Tanezumab 2.5mg Tanezumab 2.5mg dose given
subcutaneously twice at an
8-week interval.
Tanezumab 2.5mg Tanezumab 2.5mg dose given
8-week interval.
Tanezumab 10 mg Tanezumab 10 mg dose given
8-week interval.
Tanezumab 20 mg Tanezumab 20 mg dose given
8-week interval.
Tanezumab 1mg Tanezumab 1 mg dose given
8-week interval.
Placebo Comparator Placebo dose given
8-week interval.
Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
Ages Eligible for Study:18 Years and older, Genders Eligible for
Study:Both, Accepts Healthy Volunteers:No 1. Patients
with interstitial cystitis/ painful bladder syndrome for more than 6
months with moderate to severe pain and a micturition frequency
greater than 7 per day. 2. Patients who have been on stable
oral medicines for interstitial cystitis/ painful bladder syndrome for at
least 3 months. Other therapies might need to be stopped 
(there is no upper age limit for inclusion criteria for this trial)
Exclusion Criteria
1. Patients on certain recent treatments for interstitial cystitis/ painful
bladder syndrome.
2. Body mass index (BMI) of greater than 39 kg per m2.
3.History of allergic or anaphylactic reaction to a therapeutic or
diagnostic monoclonal antibody or IgG-fusion protein.
4. Patients with peripheral neuropathy.
5. Patients with Type I or type II diabetes mellitus who have an
HbA1c graeter than 8.0%.
ntry Operator Blinded

ome Timepoints
24 weeks
page 3 / 5
PDF of Trial
ome Timepoints
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
cluding SC injection site. 24 weeks

24 weeks
24 weeks
24 weeks
24 weeks
24 weeks
alysis, Clinical laboratory 24 weeks

Drug Antibody (ADA;
zumab), Adverse events
hrough the last clinic visit
e only for Completed/Terminated trials

page 4 / 5
PDF of Trial
ng a US FDA partial clinical hold for the

n 19 July 2010 for potential safety issues,
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:47:36 GMT)
ety of fixed dose combination of Ceftriaxone

ring from various bacterial infections
uate efficacy and safety of fixed dose
Ceftriaxone in subjects suffering from
Identifier
Protocol Number
Dr Mahip Saluja
Associate Professor, department of pulmonary medicine, Subharti

medical college Merrut Department of pulmonary medicine
Meerut
UTTAR PRADESH
250001
India
09837360657
drmahip@hotmail.com
Mr Pankaj
Venus Clinical Research Services

Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri
EPIP Phase-I Extention Village Bhatoli Kalan Baddi Himachal
Pradesh Venus Remedies Limited Plot no 51-52 Phase 1 Industrial
Area Panchkula
Solan
HIMACHAL PRADESH
173 205
India
01795302024
cra@venusremedies.com
Mr Pankaj
Mr Pankaj
Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri,

E.P.I.P., Phase-I, (Extention) Village Bhatoli Kalan Baddi, Himachal
Pradesh Venus Remedies Limited, Plot no-51-52 Phase-1 Industrial
Area, Panchkula
page 1 / 5
PDF of Trial
Solan
HIMACHAL PRADESH
173 205
India
01795302019
cra@venusremedies.com
ar Jharmajri, E.P.I.P., Phase-I, (Extention)
: 173 205, India

Venus Remedies Limited
Hill Top Industrial EstateNear Jharmajri, E.P.I.P., Phase-I,
(Extension) Village Bhatoli Kalan Baddi, Himachal PradeshPin code:
173 205, India
Address
#BA-58,K.H.B. ,-560032 9845932154

Quarters, Kavalabyaras Bangalore lakshmipathysr@gmail.
andra,R.T.Nagar, KARNATAKA com
Banglore-32
Basauangudi ENT Care 44/1, H. B. Samaja Roa +91-9448086243

Centre d,Basauangudi-560004 kumaragadur@hotmail.
Bangalore com
KARNATAKA
Dande Diabetes and 49 bhagwant Maya
health Care Center Nagar N-2
Maternity and Nursing CIDCO,-431005
Home Aurangabad
BIHAR
Dr. B.R. Ambedkar Prof. and Head of the +91-9845155000

Medical Department,Departmen kaigaipraj@yahoo.com
College/Hospital t of ENT, Dr. B.R.
Ambedkar Medical Coll
ege/Hospital-560045
Bangalore
KARNATAKA
Dr. Gurdeep singh, Get well hospital, 05622641276

Senior orthopedic Sikandra, Agra,-282007 getwellhospital@rediffm
surgeon Agra ail.com
UTTAR PRADESH
Dr. S.P yadav, Puspanjali Hospital,

Deaprtment of urology John Hall Road, Civil
Line Gurgaon,-122001
Not Applicable
N/A
Kharghar Diabetes and Shri Balagi krupa, plot

Heart Care Center 19 A,
Sector-20,-410210
page 2 / 5
PDF of Trial
Mumbai
MAHARASHTRA
LLRM Medical College Associate Professor 09219601795
& Hospital Meerut Department of dr_rathi_s@yahoo.co.in
Surgery,Associate
Professor & Head
Department of Surgery-
Meerut
UTTAR PRADESH
M.V. Hospital & 314/30, Mirza Mandi,

Research Center Chowk,-226003
Lucknow
UTTAR PRADESH
Makkar Medical Center A-1, Priyadarshini

Vihar,-92
New Delhi
DELHI
Narendra Prakash DA-3/1 Main Shakarpur
Health Care Center LaxmiNagar,-110092
New Delhi
DELHI
Ramakrishna Medical C-2/56 New kandli,-96

center Mother and Child New Delhi
Clinic DELHI
S.S. Institute of Medical Jnanashankara, NH 4 +91-9886767811
Science & Research Bypass,Post Box No: 1, 08192 266307
Centre Bypass Road-577005 drpatilun@yahoo.co.in
Not Applicable
N/A
Saket Hospital Senior Consultant 09814100321

Department of lalit_ortho@yahoo.co.in
Orthopedic,-134113
Panchkula
HARYANA
Subarti Medical Associate 09837360657

College, Merrut (U.P.), Professor,Department drmahip@hotmail.com
India of Pulmonary
Medicine,-
Meerut
UTTAR PRADESH

Committee?
Approved No Date Specified Not Available
page 3 / 5
PDF of Trial
Date
Date
No Date Specified
Condition
Urinary Tract Infection, Skin and skin structure
infections, Bone and joint infections, Septicemia,
Surgical prophylaxis, bacterial ottitis media,
Meningitis,LRTI
Name Details
CSE 1034 3g, OD, I.V.
Ceftriaxone 2g, OD, interavenous injection
Inclusion Criteria
12.00 Year(s)
65.00 Year(s)
Both
Male and female subjects in the age group of 12-65 years 
Clinically diagnosed subjects with Urinary Tract Infection, Skin and
skin structure infections, Bone and joint infections, Septicemia,
Surgical prophylaxis, acute bacterial ottitis media,
Meningitis,LRTI(Lower respiratory tract infections) Adult patient
willing to give written informed consent. Parent or LAR of minor
patients ready to give written informed consent.
Exclusion Criteria
History of hypersensitivity reaction or any specific contraindication to
pencillin group of drugs or cephalosporins or ceftriaxone and
sulbactam. Presence of hepatic or renal disorder History of hearing
loss Pregnant and lactating women
ome Timepoints
Clinical evaluation and Bacteriological evaluation
on screening and on completion of treatment.
Various clinical investigations shall be done
ome Timepoints
In addition to clinical observations Safety shall
be assessed by clinical investigations.
Non occurrence of drug related adverse events
page 4 / 5
PDF of Trial
valuate efficacy and safety of CSE 1034 in

rious bacterial infections.Primary out come
uations. i.e. Number of patients cured on
mber of pathogens isolated on completion
of the study drugs.
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:47:41 GMT)

H NEW ONSET PARTIAL SEIZURE: A
G SOLITARY CYSTICERCUS
AGING
H NEW ONSET PARTIAL SEIZURE: A
G SOLITARY CYSTICERCUS
AGING
Identifier
NIL
Dr Pawan Sharma
department of neurology CSM Medical University

Lucknow
UTTAR PRADESH
226003
India
05222257090
05222257090
drpawan_sharma@rediffmail.com
prof R.K.GARG
department of neurology CSM Medical University

Lucknow
UTTAR PRADESH
226003
India
05222257090
05222257090
garg50@yahoo.com
prof R.K.GARG
Department of neurology CSM Medical University
Lucknow
UTTAR PRADESH
226003
India
05222257090
page 1 / 3
PDF of Trial
05222257090
garg50@yahoo.com

none
Address
Department of Department of 05222257090

neurology neurology ,CSM 05222257090
MEDICAL garg50@yahoo.com
UNIVERSITY-226003
Lucknow
UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
epilepsy
Name Details
Name Details
not applicable not applicable
not applicable not applicable
Inclusion Criteria
The patients of new onset partial seizure of <2 week duration with
CECT brain showing solitary cystic granuloma or normal
neuroimaging including MRI BRAIN WITH GAD
Exclusion Criteria
the patientswho had received anticysticidal therapy such as
albendazole or steroid. the patients fitting in benign epilepsy
syndrome such as benign rolandic epilepsy
page 2 / 3
PDF of Trial
ome Timepoints
6 month
ome Timepoints
6 month

new onset partial seizures.the patients
hekhar et al) in CECT Brain and patients
with GAD)will be followed for seizure
ence will be compared in both the groups
page 3 / 3
PDF of Trial
un, 08 Jan 2023 04:47:47 GMT)

penem 500 mg dry powder for injection), in
reatment of Moderate to Severe infections
Identifier
NIL
Monika Obrah
Project Leader, MACR, Ranbaxy Research Laboratories, Ltd Plot

No.77-B, Sector-18, IFFCO Road
Gurgaon
HARYANA
122015
India
+9112441900-4115
+911244016855
monika.obrah@ranbaxy.com
Dr. Anudeep Sandhu
Medical Monitor, MACR, Ranbaxy Research Laboratories, Ltd Plot

Gurgaon
HARYANA
122015
India
+911244194395
+911244016855
Anudeep.sandhu@ranbaxy.com
Monika Obrah
Project Leader, MACR, Ranbaxy Research Laboratories, Ltd Plot

Gurgaon
HARYANA
122015
India
page 1 / 6
PDF of Trial
+9112441900-4115
+911244016855
monika.obrah@ranbaxy.com
gaon - 122015 , Haryana
Ranbaxy Laboratories Ltd., Plot No.20, Sector 18, Gurgaon - 122015
, Haryana
Address
AMAI Charitable Trust, AMAI Charitable Trust, suresh_iou@yahoo.co

Behind Mehendale ,Behind Mehendale m
Gavage, Erandwane Gavage, Erandwane
Pune 411004 -411004
Pune
MAHARASHTRA
Department of Surgery, Department of Surgery, gdbakhshi@yahoo.com

Grant Medical College Grant Medical College
and Sir JJ Group of and Sir JJ Group of
Hospitals, Mumbai-8 Hospitals, ,-
Mumbai
MAHARASHTRA
Dept of Surgery, Dept of Surgery, 0261-2241025

Govt.Medical College, Govt.Medical College, nimeshv@rediffmail.co
Majura Gate, Surat. Majura Gate,- m
Surat
GUJARAT
Dept of Surgery, Dept of Surgery, 09824447713

Medical College & Medical College &
S.S.G.Hospital, S.S.G.Hospital, ,-
Vadodra, Gujrat. Vadodara
GUJARAT
Dept. of Medicine, Dept. of Medicine, 09824326550
Medical College and Medical College and
SSG Hospital, SSG Hospital , ,-
Vadodara Vadodara
GUJARAT
Dr. Ram Manohar Lohia Room No.31, OPD drsood@yahoo.com

Hospital & PGIMER Building, Baba Kharak
?New Delhi ? 110001. Singh Marg,Dr. Ram
Manohar Lohia Hospital
& PGIMER -110001
New Delhi
DELHI
Dr.LH.Hiranandani Dr.LH.Hiranandani 022-25763300

Hospital, Powai, Hospital, Powai,,-
Mumbai. Mumbai
MAHARASHTRA
page 2 / 6
PDF of Trial
Gabani Kidney Gabani Kidney a_gabani@yahoo.com

Hospital, Hospital,
?Dhanlaxmi?Complex, ?Dhanlaxmi?Complex,
Near Ayurvedic Near Ayurvedic
College, Station- Lal College, ,Station- Lal
Darwaza Road, Surat, Darwaza Road, -
Gujarat. Surat
GUJARAT
Govt General Hospital Govt General Hospital 9841020556

and Madras Medical and Madras Medical
College, Chennai College, ,-600001
Chennai
TAMIL NADU
Joshi Hospital, Opp: Maharastra Medical 020-25677463

Kamala Nehru Park, Foundation -Joshi
Bhandarkar Road, Hospital, ,Bhandarkar
Erandwane, Road, Erandwane,
Pune-411044 -411044
Pune
MAHARASHTRA
Modi Clinic, Modi Clinic, 02024374047

Dr.Patwardhan Dr.Patwardhan
Hospital, Dhankawal, Hospital, Dhankawal,
Pune-411043. ,-411043
Pune
MAHARASHTRA
Premier Kidney Premier Kidney sayonib17@yahoo.co.in
Hospital, 17/B.Srinagar Hospital,
Society, Akota, m17/B.Srinagar
Vadodra, Gujrat Society,,Akota, -390022
Not Applicable
N/A
Ridhorkar Urology Ridhorkar Urology 0721-2765963

Clinic, 2nd Floor, Clinic, 2nd Floor,
Mihadia Bhawan, Mihadia Bhawan,
Lokmat Square, ,Lokmat Square,
Wardha Road, Nagpur Wardha Road, -
Nagpur
MAHARASHTRA
Shree Samarth Shree Samarth skalashetti@yahoo.com

Hospital, Karande Hospital, ,Karande
Chowk, Omkar Chowk,Omkar
Apartments, Rasta Apartments, Rasta
Peth, Pune Peth, -411011
Pune
MAHARASHTRA
Suretech Hospital & Suretech Hospital & 09326980684

Research Institute, Research Institute, dongrelalit@yahoo.com
,Banarjee Marg,
Dhantoli, -
Not Applicable
N/A
Tagore Hospital & ,-302020 09829089649

Research Institute, Jaipur drmkjain13@yahoo.co
7-Tagore Lane, RAJASTHAN m
Mansarover,
Jaipur-302020
page 3 / 6
PDF of Trial
Committee?

page 4 / 6
PDF of Trial
Date
No Date Specified
Condition
Moderate to severe infections (complicated
intrabdominal infections, complicated urinary
tract infections including pyelonephritis and
nosocomial pneumonia)
Name Details
SUDOPEN inj (Doripenem 500 500 mg IV infusion over 1hr
mg dry powder for injection) thrice daily ( at every 8 hrs)
NIL NIL
Inclusion Criteria
1. Patients of either sex, aged 18 years and above who give written
informed consent 2. Subjects diagnosed with complicated UTI
including pyelonephritis or nosocomial pneumonia or complicated
intra-abdominal infections
Exclusion Criteria
1. Subjects with known or suspected hypersensitivity to doripenem or
carbapenem or other beta lactam antibiotics. 2. subjects in whom
infection is judged to be severe or intractable that requires greater
than 10 days of therapy or require additional antimicrobial agent
(including intraperitoneal antibacterial agents) 3. Subjects with
clinically significant cardiac, pulmonary,disorder other than
nosocomial pneumonia, hepatic, renal (creatinine clearance? <30
ml/min), gastrointestinal disorders other than cIAI (such as
pseudomembranous colitis, spontaneous bacterial peritonitis),
hematologic or neurologic disease (including the subjects with
seizure disorders receiving valproate). 4. Pregnant or breast-feeding
women
ome Timepoints
At the end of study (day 7-10 post therapy)
ome Timepoints
At the end of study (day 7-10 post therapy)

page 5 / 6
PDF of Trial
arative study with an objective to assess the

oripenem 500 dry powder for injection).
. The primary efficacy outcome is clinical
reas the secondary efficacy measures will
dication). In addition, global evaluation of
by the patient as well as physician, using
oor).
page 6 / 6
PDF of Trial
un, 08 Jan 2023 04:47:55 GMT)

g-Term Safety and Efficacy of Two Doses
tting multiple sclerosis.
the Long-Term Safety and Efficacy of Two
sing-Remitting Multiple Sclerosis
Identifier
Protocol Number
EudraCT
ClinicalTrials.gov
Dr Ritika Bajaj
Associate Director
Biogen
Flat 902, Tower -18. The close South , Nirvana country , Sector-50,
Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India
9717004620
ritika.bajaj@biogen.com
Dr Ritika Bajaj
Associate Director
Biogen
Flat 902, Tower -18. The close South , Nirvana country , Sector-50,
Gurgaon , Haryana -122002
Gurgaon
HARYANA
122002
India
9717004620
ritika.bajaj@biogen.com
Mandeep Kaushal
Biogen Idec Biotech India Pvt. Ltd. 14th floor, Vatika Tower B, Sector
54
Gurgaon
HARYANA
page 1 / 7
PDF of Trial
122002
India
0124-4572351
0124-4572333
mandeep.kaushal@biogenidec.com

Biogen Idec
Biogen Idec Innovation House70 Norden Road Maidenhead
Berkshire SL4 6AY UK
Address
Post Graduate Institute Post Graduate Institute 919914209695

of Medical Education & of Medical Education 911722741279
Research Research Sector 12 dherajk@yahoo.com
Chandigarh
Chandigarh
CHANDIGARH
502, Dept. of Neurology 5th Floor Academic 91 11 2323 4350

Block, G B Pant 91 11 2323 4350
Hospital,-110002 mmmresearch@gmail.c
New Delhi om
DELHI
Amrita Institute of Amrita Institute of 9447708161

Medical Sciences Medical Sciences 9104842802135
Amrita Lane Ponekkara rsureshkumar@aims.a
Kochi Elamakkara mrita.edu
Kozhikode
KERALA
Apollo Geaneagles 58 Canal Circular 91 9830 119 686

Hospitals Road,-700054 91 33 2320 1739
Kolkata amitabha.ghosh@yaho
WEST BENGAL o.co.in
B P Poddar Hospital 71/1 Himuyan Kabir 91 9830 413 617
and Medical Research Sarani, Block G, New 91 33 2457 7009
Limited Allapore,-700053 drscmukherjee@gmail.
Kolkata com
WEST BENGAL
Christian Medical Department of 9814814004

College and Hospital Neurology Christian 01612220850
Medical College and neuroyash@yahoo.co.i
Hospital Brown Road n
Ludhiana Punjab
Ludhiana
PUNJAB
Deenanath Mangeshkar Off Karve Road, 91 20 6602 3000 Extn:

Hospital and Research Erandwane,-411004 1058
Centre Pune 91 20 6602 3012
page 2 / 7
PDF of Trial
MAHARASHTRA rahulneuro@vsnl.net
Department of 919815500720
Neurology, 3rd Floor, 911612308383
EEG Lab Civil Lines gagandeep_si@yahoo.
Tagore Nagar Ludhiana co.uk
Punjab
Ludhiana
PUNJAB
32 Sassoon 91 20 2605 9318

road,-411001 91 20 2605 9319
Pune nri_neuro@hotmail.com
MAHARASHTRA
Deralakate,- 91 9845 084 343

Bangalore 91 824 220 3747
KARNATAKA panditmng@gmail.com
3209, Avanashi 91 9842 155 101
Road,-641014 91 422 262 7782
Not Applicable kalyani_vijayan@rediff
N/A mail.com
M S Ramaiah Memorial 9448040589

Hospital NEw Bel Road 918040528402
MSRIT Banagalore drrsrinivasa@hotmail.c
Bangalore om
KARNATAKA
Mallikatta Circle, Kadri, 91 824 244 4933

Mallikatta,-575002 91 824 425 5925
Bangalore shankarmnl@hotmail.c
KARNATAKA om
Max Super Speciality 911166116666
Hospital 1 Press 911166116677
Enclave Road Delhi jd.mukherji@maxhealth
South care.com
DELHI
Neeta Mehta Clinic 919869033053

D-502, 5th Floor Rizvi 912226184448
Nagar, Milan Subway drneetamehta@gmail.c
Junction S.V. Road om
Mumbai
Mumbai (Suburban)
MAHARASHTRA
Neurology Clinic 919825465067

206-7-8 Sangini 917926405758
Complex Near Parimal drshalinshah@yahoo.c
Railway Crossing o.in
Ellisbridge Ahmedabad
Ahmadabad
GUJARAT
Ansari Nagar,-110029 91 9868 398 262

New Delhi 91 11 2658 8166
DELHI madhuribehari@hotmail
.com
,- 91 40 6646 1365
Hyderabad 91 40 6646 1365
ANDHRA PRADESH nimsneurostudies@gm
ail.com
27, Sadashiv 91 9822 719 440

Peth,-411030 91 20 2432 0681
Pune sudhirkothari@gmail.co
page 3 / 7
PDF of Trial
MAHARASHTRA m
Sir Ganga Ram Sir Ganga Ram 91142551450
Hospital Hospital Old Rajender 01145041726
Nagar New Delhi sethiprahlad@hotmail.c
Central om
DELHI
Sri Aurobindo Seva 1H, Garaihut road 91 9831 023 296

Kendra (South), Jodhpur 91 33 2499 0059
Park,-700068 pahari_ghosh@vsnl.net
Kolkata
WEST BENGAL
TNMC & BYL Nair Ch. Dr. A L Nair Road, 91 22 2302 7579
Hospital Mumbai 91 22 2302 0296
Central,-400008 nairneurology@gmail.c
Mumbai om
MAHARASHTRA
VIMHANS No. 1 Institutional Area, 91 9810 084 300

Nehru Nagar,-110065 91 11 2984 9036
New Delhi sdclinical@gmail.com
DELHI

Committee?
page 4 / 7
PDF of Trial
30/07/2011 No
29/01/2013 Yes
12/07/2011 No
14/08/2012 No
02/08/2011 No
07/01/2012 No
No Date Specified Not Available
15/08/2011 No
26/08/2011 No
05/08/2011 No
16/03/2012 No
16/08/2011 No
page 5 / 7
PDF of Trial
Date
05/12/2012
Condition
Relapsing Remitting Multiple Sclerosis
Name Details
BG00012 240mg capsule BID
BG00012 240mg Capsule TID
None None
Inclusion Criteria
1. Ability to understand the purpose and risks of the study and

provide signed and dated informed consent. 2. Subjects who
participated in and completed as per protocol previous BG00012
clinical studies 109MS301 or 109MS302. 3. All male subjects and
female subjects of childbearing potential must practice effective
contraception during the study and be willing and able to continue
contraception for 30 days after their last dose of study treatment.
Exclusion Criteria
1. Any significant change in medical history or current clinically
significant condition that in the opinion of the Investigator would have
excluded the subject's participation. 2. Subjects who discontinued
oral study treatment due to an AE or due to reasons other than
protocol-defined relapse/disability progression. 3. Subjects who
discontinued study treatment due to disability progression or
relapses and did not follow the modified visit schedule. 4. History of
malignancy, severe allergic or anaphylactic reactions. 5. Female
subjects considering becoming pregnant while in the study, currently
pregnant, or breast feeding. 6. Unwillingness or inability to comply
with the requirements of the protocol. Other unspecified reasons
page 6 / 7
PDF of Trial
that, in the opinion of the Investigator or Biogen Idec, make the

subject unsuitable for enrollment.
ome Timepoints
2 Years
ome Timepoints
2 years
2 Years
2 Years
to Determine the Long-Term Safety and
ects with Relapsing-Remitting Multiple
e and rest of world. The primary objective
BG00012 in RRMS subjects. The countries
m, Belarus, Bosnia, Bulgaria, Republic of
Estonia, France, Germany, Greece,
he Former Yugoslav Republic of
d, Puerto Rico, Romania, Serbia, Slovakia,
gdom. India will be eligible to enroll 200
ous studies (109MS301 and 109MS302).
1/000088" and "CTRI/2009/091/000117".
page 7 / 7
PDF of Trial
un, 08 Jan 2023 04:48:01 GMT)
l Registered Retrospectively
osamide Injection for the treatment of
al to Evaluate Safety and Tolerability of

ures
Identifier
Protocol Number
Dr Ripal Gharia
Scientist I (Manager)
Torrent Research Centre Village: Bhat

Gandhinagar
GUJARAT
382428
India
079-23969100
079-23969135
ripalgharia@torrentpharma.com
Dr Ripal Gharia
Scientist I (Manager)

Gandhinagar
GUJARAT
382428
India
079-23969100
079-23969135
Dr Ripal Gharian
Scientist I (Manager )

Gandhinagar
GUJARAT
382428
India
079-23969100
079-23969135
page 1 / 5
PDF of Trial

Torrent Pharmaceuticals Ltd
Torrent Pharmaceuticals Ltd, Torrent Research Centre Village: Bhat
Gandhinagar - 382 428
Address
4, Nalkung Society, Opp. Rajasthan 9825063117

Hospital, Nr. Civil ravindralodha@indiatim
Hospital gate No. 1, es.com
Shahibaug,
Ahmedabad,-
Ahmadabad
GUJARAT
Artemis Health Institute, Artemis Health Institute, 9891907903

Gurgaon. Sector- 51, Gurgaon, praveenguptapg@gmail
Haryana – 122001 .com
Gurgaon
HARYANA
Brain Care, Prince Brain Care, A-195, 9829063895

Road,Jaipur. Vidhyut Nagar, Prince drrajaram195@gmail.co
Road, Ajmer Road, m
Jaipur-302021
Jaipur
RAJASTHAN
City Neuro Centre,l City Neuro Centre, 9845510813

Mysore 483/4, Kanti Complex, keshavabelur@gmail.co
Agrahara, Near JSS m
Hospital Mysore -
570004
Mysore
KARNATAKA
M-4, Mahakant Opp. V.S.Hospital,Ellis 079-26578096
Building, Mezzanine Bridge-380006 dr.bashir52@gmail.com
Floor, Ahmadabad
GUJARAT
Paras Hospitals, C-1 Block, Sushant lok, 9717100903

Gurgaon. Gurgaon. rajnishkumar16@yahoo
Gurgaon .co.in
HARYANA
St. Johns Medical St. Johns Medical 9886732622

College Hospital, College Hospital, grk_sarma@yahoo.com
Department of Department of
Neurology,Banglore. Neurology, Sarjapur
Road, Koramangala,
Banglore-560034
Bangalore
KARNATAKA
Suman Hospital, Yeolekar mala, College 9373053461
page 2 / 5
PDF of Trial
College Road, Nasik Road, opposite Archies sanjay_varade@hotmai

Gallery, Nasik l.com
Nashik
MAHARASHTRA
Vivekanand Hospital #457/1B Vivekanand 9448114008
Road, Hubli-580029 Hospital Road, dr_ri_dugani@yahoo.co
Deshpande Nagar, .in
Hubli-580029
Dharwad
KARNATAKA

Committee?

Date
02/05/2011
Condition
Localization-related (focal) (partial) symptomatic
epilepsy and epileptic syndromes with simple
partial seizures
Name Details
Lacosamide Intravenous (Lacosamide
injection would be administered
as 30-60min infusion at 12-hr
interval for 5 days).
Inclusion Criteria
17.00 Year(s)
99.00 Year(s)
Both
1. Patients aged 17 years and above with confirmed diagnosis of
epilepsy suffering from Partial Onset Seizures, who are on oral
Lacosamide and can be temporarily switched over to intravenous
Lacosamide 2. Patients willing to give written informed consent
page 3 / 5
PDF of Trial
Exclusion Criteria
1. Patients with abnormal platelet count and unacceptable to
intravenous injections
2. Patients with seizures occurring in clusters
3. Patients with Status Epilepticus within 3 months of enrolment
4. Patients with history of non-epileptic seizures
5. Patients with known allergic reaction or intolerance to study drugs
and/or excipients
6. Patients with liver enzymes more than 2.5X the normal value
and/or bilirubin more than 1.5X the normal value and/or serum
creatinine more than the upper limit of the normal value
7. Patients with progressive structural lesions in the central nervous
system or progressive encephalopathy, progressive neurological
disorders like multiple sclerosis, Guillain-Barre syndrome
8. Patients with cardiac conduction defects and on drugs that can
prolong P-R interval
9. Patients with clinically important ECG abnormalities
10. Patients with serious psychiatric disorders like Schizophrenia,
Bipolar disorder with suicidal tendencies
11. Use of neuroleptics, MOA inhibitors, barbiturates, or narcotic
analgesics within 28 days prior to screening
12. Patients who have participated in any other investigational drug
trial within the four weeks preceding study entry
13. Women patient of childbearing potential, not practicing medically
acceptable (non-hormonal) method of contraception
14. Pregnant or lactating women, children and adolescents below 17
years
ome Timepoints
During every administration for 5 days and at the
end of 12 days of first administration
ome Timepoints
During 5 day treatment period
page 4 / 5
PDF of Trial
entric Safety & Tolerability Clinical

fety and tolerability of Lacosamide
s.
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:48:07 GMT)
drug fasudil in comparison with nimodipine
multicentre clinical trial for evaluation of

n with nimodipine following non-traumatic
Identifier
DCGI
Dr Rajendra C Rane
Sr Vice President
Intas Pharma
Intas Pharmaceuticals Chinubhai Centre Ashram Road Ahmedabad
Intas Pharmaceuticals Chinubhai Centre Ashram Road Ahmedabad
Ahmadabad
GUJARAT
380009
India
26576655
26576616
rane@intaspharma.com
Dr Kanhei Charan Sahoo
Medical adviser
Intas Pharma
Medical Services Intas Pharmaceuticals Ltd Chinubhai Center
Ashram Road
Ahmadabad
GUJARAT
380009
India
66523302
26576616
Kanheicharan_sahoo@intaspharma.com
Dr Dimple Shah
Medical adviser
Intas Pharma
Medical Services Intas Pharmaceuticals Ltd Chinubhai Center
Ashram Road
Ahmadabad
GUJARAT
380009
India
page 1 / 6
PDF of Trial
66523298
26576616
dimple_shah@intaspharma.com

Intas Pharmaceuticals Limited
Intas Pharmaceuticals Ltd Chinubhai Center Ashram Road
Ahmadabad GUJARAT 380009 India
Address
All India Institute of Assistant Professor, Jai 011-26731172;

Medical Sciences Prakash Narayan Apex 09868398244;
(AIIMS) Trauma 09968292347
Centre,,Department of +91-11-26731172
Neurosurgery, All India sumitaiims@yahoo.com
Institute of Medical ;
Sciences (AIIMS), -110 sumitneuro@gmail.com
029
Not Applicable
N/A
Ashirwad Nursing Ashirwad Nursing 09825205370;
Home Home,,Near Adarsh 0278-2423214
Complex, Jail Road, rajendrakabaria@yahoo
-364 002 .com
Bhavnagar
GUJARAT
Bhatia Hospital Bhatia Hospital,Tardeo 09820804940, 022 -

Road-400 007 6666 0000
Mumbai +91 - 22 - 66660566
MAHARASHTRA nitinsampat@hotmail.co
m
Deenanath Mangeshkar Consulting Neurologist, 09822012588, 020-660

Hospital Deenanath Mangeshkar 23000/40151000
Hospital & Research +91 20 25420104
Centre, rahulneuro@vsnl.net
,Erandawane-4110004
Pune
MAHARASHTRA
Getwell hospital Getwell hospital, 20/1, 09326014693;

Khare Marg, ,Behind 0712-6632200
Vijayanand Society, - drcspakmode@rediffma
Not Applicable il.com
N/A
Jehangir Hospital Jehangir Clinical 020-26059318

Development Centre 91-20-2605 9319
Pvt. Ltd.,,Jehangir
Hospital Premises, 32
Sassoon Road,-411
page 2 / 6
PDF of Trial
001
Pune
MAHARASHTRA
Krishna Institue of Chief Neurosurgeon, 040-2772 5119, 040-
Medical Sciences Krishna Institue of 44885450;
Medical Sciences, 09849991314
,#1-8-31/1, Minister +91-40-27840980
Road-500 003 kittureddy@hotmail.co
Not Applicable m
N/A
Sarvodaya Sarvodaya 9812006009
Multispeciality Hospital Multispeciality Hospital 01662-231010
Opp Red Cross uksarvodaya@yahoo.c
Bhawan Delhi Road om
Hisar
HARYANA
Shree Hospital Shree Hospital, Near 09820148845, 022-252

Geeta Bhawan, ,Near 8861/25283160/252896
Chembur Station, 33
Chembur (E), -400071 docrameshneuro@yaho
Mumbai o.co.in
MAHARASHTRA
Siddhi Vinayak Hospital Siddhi Vinayak 09825030365; 079-254

Hospital, Bal 65128/25471025/25471
Vatika,Maninagar 427
Road, Kankaria-380 079-25453440
008 rathisurg07@yahoo.co.i
Ahmadabad n
GUJARAT
Sir Ganga Ram Senior consultant and 09871897777,

Hospital chairman, Department 09810119091,
of Neurology, ,Sir 011-42251754/55
Ganga Ram Hospital, 011- 25861002
Rajinder Nagar,-110060 csyvaa@gmail.com
New Delhi
DELHI
Sterling Hospital Sterling Hospital, 09825073030,

,Sterling Hospital Road, 079-40011111
Memnagar, -380 052 +91-79-40011166
Ahmadabad parimaltripathi@hotmail
GUJARAT .com
Suretech Hospital and Suretech Hospital and 09822202762; 0712-66

Research Centre Research Centre,,13-A, 36850/6636801/663680
Banerjee Marg, 2/6612999
-440012 0712-2438586
Not Applicable samneuro@hotmail.co
N/A m
Surya Neuro Centre Surya Neuro Centre 09820026889,

310, Lotus House, 022-22001180/81
,33/A, New Marine 022-22001180
Lines, Next to liberty nirmal_surya@yahoo.c
Cinema, -400 020 om ; suryaneuro@hath
Mumbai way.com
MAHARASHTRA

Committee?
page 3 / 6
PDF of Trial
Date
23/07/2010
Condition
Non-traumatic subarachnoid hemorrhage
Name Details
Fasudil hydrochloride injection 1 ampoule to be dissolved in
30 mg/2 ml 100 ml normal saline
administered as intravenous
slow infusion (over 30 minutes)
every 8 hourly for 14 days
Nimodipine injection 10 mg/50 Intravenously: for the first two
ml hours about 15 microgram/kg
bw/h, may be increased to 30
microgram/kg bw/h; Patients of
body weight less than 70 kg or
with unstable blood pressure
should be started 7.5
microgram/kg bw/h; co-infusion
with intravenous fluids 40
ml/hour
Inclusion Criteria
page 4 / 6
PDF of Trial
18.00 Year(s)
70.00 Year(s)
Both
1)Either sex, age between 18 and 70 years hospitalized with
non-traumatic SAH (subarachnoid hemorrhage) 2)In case of
females with child bearing potential, negative serum pregnancy test
at screening and willing to use medically acceptable contraceptive
through out the study period 3)Himself/herself or his/her legally
accepted representative willing to provide written informed
consent 4)For whom study medication can be started within 56
hours of detection of SAH 
Exclusion Criteria
1)Recent history of stroke or subarachnoid hemorrhage 2)Patients
with hypotension (systolic blood pressure (SBP) < or = 90 mm Hg) at
baseline 3)Patient with serious disturbance of consciousness, patient
with subarachnoid hemorrhage combined with serious
cerebrovascular damage 4)Patients with presence of cerebral edema
and severely raised intracranial pressure at screening 5)Ongoing
lactation 6)Patients with pulmonary edema or severe cardiac failure
requiring inotropic support at the time of randomization 7)Hepatic
function impairment (SGPT or SGOT level > or = 2.5 times upper
normal limit) or renal function impairment (serum creatinine > or =
1.5 times upper normal limit) 8)Ongoing use of prohibited
medications ? vasodilators, nephrotoxic drugs, inhibitors of CYP
3A4, intravenous beta blockers 9)As deemed inappropriate for
enrollment by investigating physician due to other reasons
ome Timepoints
ome Timepoints
During two weeks of treatment period
ome Timepoints
1) During two weeks of treatment period
2) During two weeks of treatment period
3) At the end of study

page 5 / 6
PDF of Trial
pine in adult patients hospitalized with

major complication of subarachnoid
elayed Ischemic Neurological Deficits) due
y low density lesion on CT scan associated
sidered as primary outcome. The other
ned as a decline of at least 2 points in the
n the abbreviated National Institutes of
r DIND and modified Rankin Scale (mRS)
ynamic therapy (Tiple H therapy) or
will be conducted in Indian patients only and
ent in the study is 03-08-2010.
page 6 / 6
PDF of Trial
un, 08 Jan 2023 04:48:15 GMT)
MIGRAINE ATTACKS IN ADULT
ED, COMPARATIVE, RANDOMISED,

ORAL TABLET FORMULATION IN
CKS
Identifier
DCGI
Dr Rajendra C Rane
Sr Vice President
Intas Pharma
Ahmadabad GUJARAT 380009 India Intas Pharmaceuticals Ltd
Chinubhai Center Ashram Road Ahmadabad GUJARAT 380009
India
Ahmadabad
GUJARAT
380009
India
26576655
26576616
rane@intaspharma.com
Dr Parag Bhattacharya
Medical adviser
AGM Medical Services
Intas Pharmaceuticals Ltd. Chinubhai Centre Ashram Road
Ahmadabad
GUJARAT
380009
India
66523223
26576616
parag_bhattacharya@intaspharma.com
Dr Dimple Shah
Medical adviser
Intas Pharma
Ahmadabad GUJARAT 380009 India Intas Pharmaceuticals Ltd
Chinubhai Center Ashram Road Ahmadabad GUJARAT 380009
India
Ahmadabad
page 1 / 6
PDF of Trial
GUJARAT
380009
India
66523414
26576616
dimple_shah@intaspharma.com

Intas Pharmaceuticals Limited
Ahmadabad GUJARAT 380009 India
Address
"Archanam" Neuro 405, Twinkle 079-26760316

Clinic Complex,Near drjoshipb.gmail.com
Dhananjay Tower,
Shyamal 100-Feet
Road, Satellite-380 015
Ahmadabad
GUJARAT
Advanced Neurology Brain Tower D 358 09829059370

and Superspeciality Malviya Nagar Near sunitanu@yahoo.com
Hospital Gaurav Tower 302 017
Jaipur
RAJASTHAN
Bombay Hospital Room No. 18, 1st Floor, 09826049491;
Bombay Hospital,Ring 0731-4077000-Ex.
Road - 10, Near 2118
Vijaynagar atul_taparia@yahoo.co
Chouraha-452 010 m
Indore
MADHYA PRADESH
Dept. of Neurology, D Y Dept. of Neurology, D Y 27709590;

Patil Hospital Patil Hospital,Sector 0484-2313903
No. 5, Nerul-400 706
Mumbai
MAHARASHTRA
Dr. Ravindra Lodha's 4, Nal Kunj Society,Civil 09825063117;

Clinic Camp 079-22684422
Road,Shahibaug,-380 ravindralodha@indiatim
004 es.com
Ahmadabad
GUJARAT
Nagpal Neuro Medical Khusi Plaza, In Front of 09827047665;

Centre Bhanwar Tal,Krishna 07614035194
Hotel Road, Napier tarunnagpal@hotmail.c
Town-482 001 om
Jabalpur
page 2 / 6
PDF of Trial
MADHYA PRADESH
Neuro Care Clinic and 303, Shubham 09979935482;
Research Centre Complex, 8, Sardar 079-30179488
Patel Colony,Near drdharmesh2003@yah
Usmanpura oo.com
Underbridge,
Naranpura-380 013
Ahmadabad
GUJARAT
Neuro Care Speciality Shop No. 3, Ambica 09220887386;

Clinic Cooperative Housing 0251-2201531
Society Plot No. dr_pvinod@yahoo.co.in
1,Santoshi Mata
Chowk-421 301
Thane
MAHARASHTRA
Neurocare and 804 Param Doctor 09898129818;
Electrophysiology Clinic House,Near Aayush DR 0261-2419818
House, Lal drparhivdesai@gmail.c
Darwaja-Station om
Road-395 003
Surat
GUJARAT
Neurology Centre 241, Sector 4, Hiran 09829279719;

Magri,-313 001 0294-2465050
Udaipur vatsneuro@gmail.com;
RAJASTHAN vatsneuro@yahoo.com
Neurology Centre C-11, BDA Colony,6 09425607527;

No. Bus Stop-462 027 0755-2770555
Bhopal drsunilmalik2003@yaho
MADHYA PRADESH o.co.in
Neurology Clinic 122 Madhav Nagar, 09826292190;

Opp. A.G. Office,Jhansi 0751-4081133
Road, Lashkar-474 003 drdineshudainia@gmail
Gwalior .com
MADHYA PRADESH
Sahni Neuro Care Shop No. 8, JDA 09329702244;

Centre Complex,Opp. Milan 0761-3293873
Sweets, Near Madan anupamsahni@yahoo.c
Mahal Square, Nagpur om
Road-482 001
Jabalpur
MADHYA PRADESH
SMS Hospital Sawai ManSingh 09414073579;

Hospital ,-302 001 0141-2560291
Jaipur drrsjain@yahoo.com
RAJASTHAN
Vimala Neurology G-3, Urmila 09821018826;

centre and EEG Clinic Commercial 022-25282450
Complex,Opp. Hotel drganeshkini@yahoo.c
Malhar, Chembur-400 o.in
071
Mumbai
MAHARASHTRA

Committee?
page 3 / 6
PDF of Trial

Date
12/05/2010
Condition
Migraine in adult patients
Name Details
page 4 / 6
PDF of Trial
Eletriptan Hydrobromide One tablet will be taken orally at

equivalent to eletriptan 40mg the start of a migraine episode.
oral conventional tablets Patients who do not adequately
respond to the initial dose of the
study medication or experience
headache recurrence, can
repeat the same dose once
between 2 and 24 hours after
the first dose
Sumatriptan Succinate One tablet will be taken orally at

equivalent to Sumatriptan 50mg the start of a migraine episode.
oral conventional tablets Patients who do not adequately
respond to the initial dose of the
study medication or experience
headache recurrence, can
repeat the same dose once
between 2 and 24 hours after
the first dose
Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
1)Male and female adult patients aged 18 to 65 years and having the
diagnosis of migraine with or without aura according to International
Headache Society criteria 2)May or may not be taking
prophylactic treatments for migraine 3)Frequency of migraine
episodes is 1 to 6 per month 4)Minimum duration of the illness
is 1 year 5)Migraine onset is before the age of 50 years 
6)Female patients who meet the above criteria must also meet the
following additional criteria: - Post-menopausal - If of
child-bearing potential, must be using medically acceptable
contraception, and must consent to use barrier method of
contraception before entry and throughout the study, or are surgically
sterilised, or has a male partner who has undergone
sterilization - Must have a negative result of serum pregnancy
test at screening 7)Subjects fulfilling the above criteria and who
are willing to provide their informed consent, indicating that they
understand the purpose of and procedures required for the study and
are willing to participate in the study. 8)Subjects must be willing
to fill-up the migraine diary (provided to them) during each migraine
attack and up to three times that they may suffer over the study
period 9)Subjects must be compliant with self-administration of
medication. 
Exclusion Criteria
A patient is excluded from the study if he or she meets any of the
following criteria: 1)Atypical migraine that has consistently failed to
respond to migraine therapy 2)Concomitant frequent non-migrainous
headache (e. g., more than 6 attacks per month on average)
3)Presence of migraine with prolonged aura, familial hemiplegic
migraine, basilar migraine, or migrainous infarction 4)Any acute or
unstable medical condition 5)Conditions associated with severely
limited gastrointestinal absorption 6)Any medical condition (including
documented hypersensitivity) that contraindicates the use of triptan
drugs 7)Use of drugs that can interact with the triptans 8)History of
misuse of analgesic drugs (defined as use of >50 g of aspirin or
>100 tablets of analgesics in one week) or ergotamine (defined as
use on >2 days per week) 9)Misuse or abuse of alcohol or other
substances, based on the Diagnostic and Statistical Manual of
page 5 / 6
PDF of Trial
Mental Disorders Version IV (DSM-IV) criteria 10)Clinically significant
abnormal laboratory test values at baseline 11)Subjects whose
baseline electrocardiogram (ECG) has been reported other than
"within normal limits" 12)Use of investigational drugs within 1 month
prior to screening 13)Unable or unwilling to provide written informed
consent 14)Not willing to fill-up the migraine diary during an episode
of migraine 15) Pregnant women and lactating mothers 16)Women
of child-bearing potential not taking effective contraceptive
precaution 17)Women of child-bearing potential not consenting to
use barrier contraceptives 18)Have a history of repeated
non-compliance with treatment
ome Timepoints
After 1st migraine episode
ome Timepoints
al response After 1st , 2nd and 3rd migraine episodes
ee response
associated symptoms
eptability of the study
ation
che response at 2 hours
and efficacy of eletriptan 40mg oral tablet

ion in adult patients with multiple episodes
d to be as effective as, and better tolerated
raine in adult patients. The trial will be
nly. Anticipated date for first patient
page 6 / 6
PDF of Trial
un, 08 Jan 2023 04:48:21 GMT)
nal and neuroplastic changes in post Stroke
nal and neuroplastic changes in post Stroke
Identifier
NIL
Prof. Rajesh Verma
Department of Neurology CSMMU(KGMU)

Lucknow
UTTAR PRADESH
226003
India
08127442407
drrajeshverma32@yahoo.com, kamalnarya@yahoo.com
Prof. Rajesh Verma
Lucknow
UTTAR PRADESH
226003
India
08127442407
Prof. Rajesh Verma

Lucknow
UTTAR PRADESH
226003
India
08127442407
page 1 / 3
PDF of Trial

NIL
Address
Dept. of Neurology, CSMMU,-226003 08127442407

CSMMU, Lucknow, UP, Lucknow kamalnarya@yahoo.co
India. UTTAR PRADESH m

Committee?
Committee?
Date
No Date Specified
Condition
Post Stroke subjects with hemiperesis
Name Details
Meaningful Task Specific
Training (MTST)
Conventional rehabilitation
(Brunnstrom & Bobath)
Inclusion Criteria
Age: 18 to 60 year, both male & female Hemiparesis (both right

& left) unilateral stroke Normal one side vision Able to cope with
intensive training program Medically stable Able to understand
instructions 4 to 24 weeks after stroke Modified Ashworth Scale -
1,1+, 2, Brunnstrom Recovery Stage-Arm-2,3,4 & 5 Functional
Ambulation Classificatio- I & above
Exclusion Criteria
Severe Aphasia (NIHSS*- 2 & 3) Cerebellar or thalamic infarct
Uncontrolled systemic or cardiovascular disease Fixed contractures
Shoulder subluxation Cortical blindness (NIHSS - 2 & 3) Multiple
stroke Ataxia Severe sensory loss (NIHSS -2) Dementia Participation
in any Pharmacological trial Severe depression *(National Institutes
of Health Stroke Scale-NIHSS)
page 2 / 3
PDF of Trial
ome Timepoints
Pre intervention, Post intervention, Follow up
after 4 week
ome Timepoints
ome Timepoints
Pre intervention, Post intervention, Follow up
after 4 week

ntries including India. It can cause deficits

e motor system.Standard motor
n eclectic mix of approaches. However no
otor deficit, making motor rehabilitation for
al & research evidence for these methods.
killed motor performance is the critical link
ntral nervous system (CNS) Numerous
er type of task and specific method of
stic changes in stroke patients has not
ore specific training methods based on
d neuroplastic changes in Stroke patients.
page 3 / 3
PDF of Trial
un, 08 Jan 2023 04:48:26 GMT)
ery (medical therapy) in Childhood Drug
g list surgery in childhood intractable
Identifier
NIL
Manjari Tripathi
Additional Professor
Dept.of Neurology
Room No-705, 7th Floor,C.N.C. AIIMS
New Delhi
DELHI
110029
India
011-26594494
manjari.tripathi@gmail.com
Dr Manjari Tripathi
Dept of Neurology
Room No-705,7th Floor, CNC,AIIMS
New Delhi
DELHI
110029
India
011-26594494
Rekha Dwivedi
Room No-705,Dept of Neurology 7th Floor,CNC,AIIMS

New Delhi
DELHI
110029
India
011-26594494
rekha.dwivedi2006@gmail.com
page 1 / 3
PDF of Trial

All India Institute of Medical Sciences AIIMS
Ansari Nagar New Delhi INDIA PIN CODE 110029
Research institution and hospital
Address
AIIMS Ansari 011-26594494

Nagar,AIIMS-110029 manjari.tripathi@gmail.
New Delhi com
DELHI

Committee?

Date
No Date Specified
Condition
Childhood Intractable Epilepsy
Epilepsy, unspecified
Name Details
Early Epilepsy surgery After randomization subject will
be enrolled within one month
usual waiting list epilepsy Subject will be enrolled as per
surgery or Medical therapy the usual waiting list of surgery
(medical therapy till dated
surgery) that may be one year
or so.
Inclusion Criteria
1.00 Month(s)
18.00 Year(s)
Both
1) All children with DRE patients: age ?18 years. 2)
Patients having DRE, defined as failure of adequate trials of two
tolerated and appropriately chosen and used anti-epileptic drug
schedules for years to achieve sustained seizure freedom. 
 3)All patients should have been cleared by the Unit III-epilepsy
surgery-case conferences team. 4)All parents of patients
or Legally Acceptable Representative (LAR)should be able to give
Consent for participation.
Exclusion Criteria
page 2 / 3
PDF of Trial
1) All patients who have underlying metabolic abnormality, cardiac

abnormality, renal failure and respiratory disease.
2) Those patients having Status Epilepticus requiring early or
immediate surgery(as these are not put in wait list).
ome Timepoints
Baseline, Six months and one year follow-up.
ome Timepoints
es in the occurrence of Baseline,Six months and One year follow-up
d of 12 months, and
on, behavior and quality
measures: the Hague
scale, Binet Kamat Test
Social Maturity Scale
or Check List (CBCL)
(PedsQL), respectively.
efficacy of the early epilepsy surgery
al therapy) in surgically remediable
in All India Institute of medical Sciences
s to assess the outcome of seizures in the
aiting list surgery with medical therapy
jective of the study is to evaluate seizure
nical and neuro-psychological assessment
al Maturity Scale (VSMS), Child Behavior
L), respectively between the two groups .
page 3 / 3
PDF of Trial
un, 08 Jan 2023 04:48:33 GMT)
tive Bladder
parallel group, placebo and active
of overactive bladder
Identifier
Protocol Number
ClinicalTrials.gov
Dr Shoibal Mukherjee
Vice President, Medical
IQVIA RDS (India) Private Limited
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
IQVIA RDS (India) Private Limited
301-A-1, Leela Business Park MV Road, Andheri East, Mumbai
400059
Mumbai
MAHARASHTRA
400059
India
91-9820712114
page 1 / 5
PDF of Trial
91-22-56774343
suchela.srivatsa@quintiles.com
ku, Tokyo 174-8612 Japan
Astellas Pharma Inc
17-1, Hasune 3-chome, Itabashi-ku,Tokyo 174-8612, Japan
Address
B-101-106, Shapath IV, Opp. Karnavati Club,
Sarkhej – Gandhinagar Road, Ahmedabad 380
051
051
Dr. Ram Manohar Lohia Room No. 31, OPD 011-23404323

Hospital & PGI MER block,,Baba Kharag 011-23404323
Singh Marg, -110001 drsoodr@yahoo.com
New Delhi
DELHI
Government Of India, 3rd floor,,Blood Bank 011-26190954

Department Of Urology, Building, -110029 011-26190954
V.M. Medical College & New Delhi nayankm@yahoo.com
Safdarjang Hospital DELHI
Indraprastha Apollo Sarita Vihar, 011-26925858

Hospitals ,Delhi-Mathura Road, 011-2682329
-110076 drnsubr@yahoo.co.in
New Delhi
DELHI
Medanta, The Medicity Sector 38, ,-122001 0124-4141414

Not Applicable rajesh.ahlvat@medanta
N/A .org
Monilek Hospital & Sector-4, ,Jawahar 0141-2653021

Research Centre Nagar, -302004 0141- 2652830
Jaipur sltolani@gmail.com
RAJASTHAN
Noble Hospital 153, ,Magarpatta City 020-26137494

Road, -411013 020-26055094
Pune rajendrakshimpi@gmail
MAHARASHTRA .com
Samved Hospital On Stadium Circle to 079-26431616

Commerce College Roa 079-26420285
d,,Navrangpura,-38000 drjanak@samvedurolog
9 y.com
Ahmadabad
GUJARAT
Sanjay Gandhi Post Raebareli 0522-2668700

Graduate Institute Of Road,-226014 0522-2668056
page 2 / 5
PDF of Trial
Medical Sciences Lucknow rkapoor@sgpgi.ac.in
UTTAR PRADESH
Committee?
Approved 10/06/2010 Not Available
Date
12/04/2010
Condition
Bladder disorder, unspecified
Symptoms of overactive bladder
Name Details
YM178 modified-release tablet Oral, Dose X Once Daily
Tolterodine Capsule Oral, Dose Y Once Daily
Placebo Tablet/Capsule Oral, Dose X/Y Once Daily
page 3 / 5
PDF of Trial
Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
Ages Eligible for Study: 18 Years and older, Genders Eligible
for Study: Both, Accepts Healthy Volunteers: No. 
 Inclusion Criteria: 1. Subjects with symptoms of
overactive bladder for at least 12 weeks before the study 2.
Subjects capable of walking to the lavatory without assistance and
measuring the urine volume by him/herself 3. Subject with an
average frequency of micturition of 8 or more times per 24-hour
period 4. Subject with an average episode of urgency or urge
incontinence of one or more times per 24-hours period 5.
Subject having provided written informed consent by him/herself
 
Exclusion Criteria
1. Subject having stress urinary incontinence as a predominant
symptom 2. Subject with transient symptoms suspected for
overactive bladder 3. Subject complicated with urinary tract infection,
urinary stones, and/or interstitial cystitis or with a historical condition
of recurrent urinary tract infection 4. Subject complicated with
bladder tumor/prostatic tumor or with the historical condition 5.
Subject confirmed to have a post-void residual volume of >=100ml or
with a clinically significant lower urinary tract obstructive disease 6.
Subject with indwelling catheter or practicing intermittent
self-catheterization 7. Subject giving radiotherapy influencing urinary
tract functions, or thermotherapy for benign prostatic hyperplasia 8.
Subject giving surgical therapy which may influence urinary tract
functions within 24 weeks before the study 9. Subject with
uncontrolled hypertension (indicated by sitting SBP >=180mmHg or
DPB >= 110mmHg) 10. Subject with a pulse rate >= 110bpm or <50
bpm
ome Timepoints
Time Frame: Within a 12-week treatment period
ome Timepoints
Time Frame: During 12-week treatment
page 4 / 5
PDF of Trial
center study to assess the efficacy and the

bladder. Globally 1300 subjects will be
33 subjects. Tentative date for 1st patient
al is conducted with conditional approval
>= 18 years and =< 65 years).
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:48:39 GMT)

Imagery for Gait Rehabilitation in Post
Imagery for Gait Rehabilitation in Post
Identifier
NIL
Prof. Rajesh Verma
Department of Neurology CSMMU (KGMU)

Lucknow
UTTAR PRADESH
226003
India
05222253158
drrajeshverma32@yahoo.com
Prof. Rajesh Verma

Lucknow
UTTAR PRADESH
226003
India
05222253158
Prof. Rajesh Verma

Lucknow
UTTAR PRADESH
226003
India
05222253158
page 1 / 3
PDF of Trial

NIL
Address
Department of CSMMU,KGMU-22600 08127442407,

Neurology 3 09899897408
Lucknow kamalnarya@yahoo.co
UTTAR PRADESH m

Committee?
Date
No Date Specified
Condition
Post stroke patients with gait dysfunction
Name Details
Task-oriented Circuit Class
Training Program with Motor
Imagery
Conventional Gait rehabilitation
Inclusion Criteria
?Age: 18 to 60 year, both male & female ?Ischaemic or
haemorrhagic stroke ?With in 7 days of hospitalization ?Hemiparesis
(both right & left) ?normal one side vision ?medically stable
?able to cope with intensive training program ?able to understand
instructions ?ability for mental imaging ?Functional Ambulation
Classification II & abov
Exclusion Criteria
?Cerebellar or thalamic infarct ?uncontrolled systemic disease
?Cardiovascular problems ?Multiple strokes ?Dementia ?Fixed
contractures of gastrosoleus/TA
page 2 / 3
PDF of Trial
ome Timepoints
Assessments will be taken at baseline, 2nd week
(post intervention)and 6th weeks (follow up)
ome Timepoints
Assessments will be taken at baseline, 2nd week
(post intervention)and 6th weeks (follow up)

ercent of individuals who sustain a stroke

ted to walking. While the majority of stroke
e assistance with walking and of those who
lation.Rehabilitation provided for patients
quently consists of exercise therapy based
e of pre walking functional tasks such as
the maintenance of unassisted stance.
e or twice a day for only a few minutes) and
ercent of individuals who sustain a stroke
ted to walking. While the majority of stroke
e assistance with walking and of those who
lation.Rehabilitation provided for patients
quently consists of exercise therapy based
e of pre walking functional tasks such as
the maintenance of unassisted stance.
e or twice a day for only a few minutes) and
s highlighted the importance of intensive
adjust the conditions of walking practice
of the individual.Another cost effective
patients through the nonhazardous,
s may be realized through the use of motor
ce MI practice alone can not solve the
tocol. In the absence of any such highly
riented Circuit Class training for gait
oach.
page 3 / 3
PDF of Trial
un, 08 Jan 2023 04:48:45 GMT)
Zonisamide in Paediatric Partial Onset

, Randomised, Placebo-controlled,
Adjunctive Zonisamide in Paediatric Partial
Identifier
Protocol Number
ClinicalTrials.gov

Dr Shoibal Mukherjee
Vice President, Medical
Quintiles Research (India) Pvt Ltd.
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
Quintiles Research (India) Pvt. Ltd.
301-A-1, Leela Business Park MV Road, Andheri East, Mumbai
400059
Mumbai
MAHARASHTRA
400059
India
page 1 / 5
PDF of Trial
91-9820712114
91-22-56774343
suchela.srivatsa@quintiles.com
Way Hatfield Hertfordshire AL10 9SN
0 8600 1401

Eisai Limited
European Knowledge Centre Mosquito Way Hatfield
HertfordshireAL10 9SN United Kingdom
Address
051, Gujarat, India
Brain and Mind Institute B-101, Neeti Gaurav Co 0712 2428701

mplex,Ramdaspeth-440 0712 2451626
010 drmeshram@hotmail.co
Nagpur m
MAHARASHTRA
Indraprastha Apollo Sarita Vihar,-110 076 011 26925825

Hospital New Delhi 01141677024
DELHI vineetgupta6@hotmail.
com
Jaslok Hospital and 15, Dr. G. Deshmukh 09820186155

Research Centre marg,-400026 022-23512922
Mumbai anaitahegde@gmail.co
MAHARASHTRA m
Kanchi Kamakoti Child Nungambakkam,-60003 044 42001800
Trust Hospital 4 044 43021910
Chennai vishneuro@gmail.com
TAMIL NADU
KEM Hospital, KEM Sir Moodiliar 09850066005

hospiatl Research Marg,Rasta 020 26055067
centre Peth-411011 nandanyardi@rediffmail
Pune .com
MAHARASHTRA
page 2 / 5
PDF of Trial
Mallikatta Neuro Centre opp. Mallikatta 09739462974

Circle,Kadri-575002 0824-4255925
KARNATAKA om
Neurology Clinic 55, Ravindra 09415175001
Palli,Faizabad 052-22351100
Road-226016 dratul1@rediffmail.com
Lucknow
UTTAR PRADESH
Nizam's Institute of Department of Neurolog 09704822022

Medical Sciences y,Punjagutta-500082 040 23300833
Hyderabad drjabeennims@gmail.c
ANDHRA PRADESH om
Seth G. S. Medical Department of 09820310850

College & KEM Hospital Neurology,Parel-40001 022-24164206
2 ravatsh@yahoo.com
Mumbai
MAHARASHTRA

Committee?
Submittted/Under No Date Specified Not Available

Review
page 3 / 5
PDF of Trial
Date
17/01/2011
Condition
Partial Seizures
Name Details
Open-Label Period:Zonisamide. 1 to 8 mg/kg orally per day for
approximately 59 weeks
Transition Period from Study 1 to 8 mg/kg orally per day for
E2090-E044-312: Placebo approximately 59 weeks
Inclusion Criteria
6.00 Year(s)
17.00 Year(s)
Both
1.Subject has completed the double-blind study,
E2090-E044-312. 2.Parent/caregiver is willing to sign an
informed consent where the subject is under the age of
consent. 3.Subject is male or female aged 6?18 years inclusive,
who is willing to give informed (written or verbal) assent, if
applicable. If mandated by local regulations, subjects of 
relevant age will be required to sign an appropriate informed
consent. 4.Subject is in general good health as determined by
medical history, physical exam and screening laboratory
results. 
Exclusion Criteria
1.Subject has a body weight < 20 kg. 2.Subject has developed a
history of renal calculi or renal insufficiency (creatinine level > 135
μmol/l (1.5 mg/dl) 3.Subject has a known diagnosis of human
immunodeficiency virus (HIV) or hepatitis B or C. 4.Subject has a
history of sensitivity to sulfonamide drugs or to zonisamide and its
excipients. 5.Female subject of 10 years of age or greater, or of child
bearing potential (i.e. started menses) and is not taking or prepared
to take a medically acceptable form of contraception (i.e. oral
contraceptive pill, surgical sterilisation, an implant or injected form of
contraception, or intrauterine device), or who is not prepared to
abstain from sexual activity for the duration of the study and for 1
month after the last administration of study medication. NOTE:
Should a female subject become of child bearing potential during the
study, they must be re-consented in order to undergo pregnancy
testing and either confirm abstinence or receive a medically
appropriate form of contraception. 6.Subject has a recent history of
excessive alcohol use or drug abuse. 7.Subject has a history of
suicide attempt. 8.Subject has a clinically significant organic disease.
9.Subject has a history of demonstrated non-compliance with
treatment or subject or parent/ legal guardian can be reasonably
expected not to be compliant with study procedures or to complete
the study. 10.Frequent need of rescue benzodiazepines (> once a
week). 11.Concomitant use of acetazolamide, carbonic anhydrase
inhibitors such as topiramate, furosemide and drugs with
anticholinergic activity. 12.Concomitant use of felbamate or use of
felbamate within 3 months prior to Visit 1 in the E2090-E044-312
study.
page 4 / 5
PDF of Trial
ome Timepoints
ome Timepoints
Time Frame: 59 weeks
ome Timepoints
Time Frame: 59 weeks

2090-E044-312) will be invited to

two main parts: Transition Period
rt with the Transition Period during which
e dose of zonisamide and those who were
of zonisamide. After all subjects have
pen-label with every subject on the study
n once daily in the evening. For those
nisamide will start with a dose of
ed from the previous study, these subjects
capsules as they were taking in the
he up- titration is completed. Those
n the same dose which they received
tudy. In order that the blind is maintained,
e up- titration dose regimen of the subjects
E044-312 study. All subjects will stop taking
The duration of the Transition Period
ved when completing the core study
the Transition Period will last 7 weeks. For
. However, during the double-blind
e events (AEs). If this should occur, the
mal dose. The overall duration of the study
nrolled in the trial whereas from India 60
ment: January 19, 2011 Please note that the
ch is already registered at CTRI registry
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:48:54 GMT)
n treatment of Premature Ejaculation

ne Hydrochloride Tablet in treatment of
Identifier
Protocol Number
Dr. Hemang Desai
306, Sangini Complex, Nr. Doctor House Parimal Gardan,

Ellisbridge,
Ahmadabad
GUJARAT
380006
India
niyatide@gmail.com
Dr. Onkar Swami
Emcure Pharmaceuticals Ltd

Emcure Pharmaceuticals Ltd Rajiv Gandhi IT Park Phase I, MIDC,
Hinjwadi
Pune
MAHARASHTRA
411057
India
020-39821000
020-39821019
Onkar.Swami@emcure.co.in
Dr. Onkar Swami
Emcure Pharmaceuticals Ltd Rajiv Gandhi IT Park Phase I, MIDC,

Hinjwadi
Pune
MAHARASHTRA
411057
India
020-39821000
page 1 / 8
PDF of Trial
020-39821019

Emcure Pharmaceuticals Ltd, Pune
Address

Aashray Clinic 114, Span Trade
Centre,,Opp. Kocharab
Aashram,Near Paldi
Cross Road,
Ellisbridge,-380006
Ahmadabad
GUJARAT
Abhaya Hospital # 17, Dr. M. H. Mari

Gowda Road (Hosur
Road),,Opp. 9th cross
Bus stop, Wilson
Garden,-560027
Bangalore
KARNATAKA
Dr. Abhay Paliwal 2-A Kailash Park, abhaypaliwal@yahoo.c

Pragati om
Appartment,,Gita
Bhawan Main
Road,-452001
Indore
MADHYA PRADESH
Dr. Hemang Desai 306, Sangini Complex, niyatide@gmail.com

Nr. Doctor
House,Parimal Gardan,
Ellisbridge,-380006
Ahmadabad
GUJARAT
Dr. Pratap Panhale?s 11, Maruti Complex, ppanhale@rediffmail.co

Clinic ,Opp. Central Bus m
Stand-413512
Latur
MAHARASHTRA
Dr. Sanjay Phadke's G -01 A J Arcade, Opp. sanjay_phadke@hotma

Clinic Ashish Gardan,D. P. il.com
Road, Kothrud-411038
Pune
MAHARASHTRA
Dr. Vilas Bhailume, Aroma Terraces, Flat

MBBS; DPM No 1, State Bank
Nagar,,Karve Nagar,
page 2 / 8
PDF of Trial
Warje Road, -411052

Pune
MAHARASHTRA
10, Jerbai Baug, Near
Gloria Church,,B.A.
Road, Byculla
(East),-400027
Mumbai
MAHARASHTRA
Malaparamba,-673009 drpnsuresh@satyam.ne
Not Applicable t.in
N/A
2nd floor, Parekh kausar16@sify.com
Center,Opp. Daga
Hospital, Gandhi
Bag,-440018
Nagpur
MAHARASHTRA
611, K K
Nagar,-625020
Madurai
TAMIL NADU
1st Floor, Above HDFC dsdjadhav@yahoo.co.in

Bank, Santoshi Mata
Road, ,Saraswati
Building,-421301
Not Applicable
N/A
119, Niranjan, Budhwar drtembe@gmail.com

Peth,Station Road-
Not Applicable
N/A
1671-75, Ganesh Khind

Road, ,Behind Hotel
Pride, Shivaji
Nagar,-411005
Pune
MAHARASHTRA
Malpani Pride, Near umeshanjali@gmail.co

Raymond m
Showroom,,Sharanpur
Road-422002
Not Applicable
N/A
30 C Erandwane, Karve
Road,,-411004
Pune
MAHARASHTRA
312 Starlit Towers, Y. ujwalsardesai@yahoo.c

N. Road,-452003 o.in
Indore
MADHYA PRADESH
Below Karnawati Hospit

al,Ellisbridge-380006
Ahmadabad
GUJARAT
4, Vijay Nagar, ,Opp. sanjeev.saoji@gmail.co
Jawahar Nagar Police
page 3 / 8
PDF of Trial
Station,Garkheda m
Road,-431005
Aurangabad
BIHAR
Sardesai Clinic Shamala Apts, 968/3,
Senapati Bapat
Road,,Next to Vidya
Sahakari Bank,-411016
Pune
MAHARASHTRA
Shradha Nursing Home 10-B, Samtanagar,Opp. a.marwale@rediffmail.c

Brotherhood om
Church-431001
Aurangabad
BIHAR
Spandana Nursing 549/46, 6th Main, 4th

Home Block, Rajaji
Nagar,-560010
Bangalore
KARNATAKA
Swaminarayan Clinic B/106, Priya

and Nursing Home Apartments, Main
Carter Road, ,Opp Vyas
Chemist, Borivali
(E)-400066
Mumbai
MAHARASHTRA
Tan-Man Clinic 33/3 Shakti drrajeshgoyal_2002@y

Nagar,,-110007 ahoo.com
New Delhi
DELHI

Committee?

page 4 / 8
PDF of Trial

page 5 / 8
PDF of Trial

Date
No Date Specified
Condition
Premature Ejaculation
Name Details
Dapoxetine Hydrochloride One tablet,to be taken
approximately 1 to 3 hours prior
to sexual activity for 8 weeks
Placebo One tablet,to be taken
approximately 1 to 3 hours prior
to sexual activity for 8 weeks
Inclusion Criteria
1.Male subjects between 18 to 64 years of age. 2.Male subjects with

stable, monogamous, heterosexual relationship with same woman
for at least 6 months and expected/planned to maintain this
relationship for duration of study. 3.Subjects meeting with diagnostic
criteria for premature ejaculation (PE score ≥ 11) as
specified in article published in European Urology 2007, 52: 565 ?
573. 4.Subject and his partner agreeing to attempt sexual
intercourse 2 times/ week. 5.Subject willing to give written informed
consent and willing to comply with trial protocol.
Exclusion Criteria
1.Previous events or other conditions associated with premature
ejaculation including but not limited to spinal trauma or pelvic
surgery. 2.Subjects with premature ejaculation due medication
withdrawal. 3.Erectile dysfunction or any other sexual dysfunction
except premature ejaculation. 4.Sexual dysfunction in female
partner, painful intercourse, partners with decreased interest in
intercourse or other forms of sexual dysfunction. 5.Subjects with
major psychiatric illness or previous suicidal attempts. 6.Subjects
with history of epilepsy. 7.Subjects taking concurrent drug therapies
OR within last 14 days of discontinuing treatment with : Monoamine
page 6 / 8
PDF of Trial
oxidase inhibitor (MAOIs), Thioridazine, Selective serotonin reuptake

inhibitor (SSRI), selective-norepinephrine reuptake inhibitor (SNRI),
serotonergic medicinal/herbal products, tricyclic antidepressants, and
atypical antipsychotics 8.Subjects taking concurrent treatment of:
ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin,
nefazadone, nelfinavir, atazanavir, erythromycin, clarithromycin,
fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil,
diltiazem, any vasodilators, antiplatelet, anticoagulants, PDE5
inhibitors, alcohol and any other recreational drug. 9.Use of other
form of therapy (Pharmacological/ Behavioral) for premature
ejaculation. 10.Patients with significant
hematological/metabolic/endocrinologial (excluding type 2 Diabetes
Mellitus) /respiratory/cardiovascular/neurological/psychiatric
/liver/kidney diseases 11.Uncontrolled Hypertension OR History of
orthostatic hypotension 12.Known hypersensitivity to SSRI, SNRI,
and any constituent of the Test formulation. 13.Subjects with cardiac
arrhythmia or any abnormality on ECG. 14.Subjects with previous
history of bone marrow depression. 15.Patients who will receive
some other drug during the study besides that in the protocol that
could alter the pharmacokinetic/ pharmacodynamic profile of the
study drug. 16.Patients with Alcohol or drug abuse. 17.Any condition
that, in the opinion of the investigator, does not justify the patient?s
inclusion in the study.
ome Timepoints
4 weeks and 8 weeks
ome Timepoints
Baseline, 4 weeks and 8 weeks

will assess the effeicacy and safety of
clusion/exclusiuon criteria will be
tely 1 to 3 hours prior to sexual activity for
page 7 / 8
PDF of Trial
4 and 8 weeks of therapy for efficacy and

ne at baseline and after completion of therapy.
page 8 / 8
PDF of Trial
un, 08 Jan 2023 04:49:00 GMT)
ogical scores in patients of acute ischemic
ase III clinical study to compare the

bo alongwith standard supportive care in
Identifier
Other
Dr Uma Sundar
Professor
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak
Municipal General Hospital Sion Mumbai
Department of Neurology Services Internal Medicaine Lokmanya
Tilak Municipal Medical College & Lokmanya Tilak Municipal General
Hospital Sion Mumbai
Mumbai
MAHARASHTRA
400022
India
umasundar2@rediffmail.com
Dr Uma Sundar
Professor
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak
Municipal General Hospital Sion Mumbai
Department of Neurology Services Internal Medicaine Lokmanya
Tilak Municipal Medical College & Lokmanya Tilak Municipal General
Hospital Sion Mumbai
Mumbai
MAHARASHTRA
400022
India
umasundar2@rediffmail.com
Naju Turakhia
General Manager- Clinical Research
Bharat Serums and Vaccines Ltd
Bharat Serums and Vaccines Ltd 1st Floor Building No1 Business
Development Centre Near Tatwagyan Vidyapeeth Ghodbunder Road
page 1 / 5
PDF of Trial
Thane (West)
Thane
MAHARASHTRA
400610
India
02261383409
02261383400
Naju.Turakhia@bharatserums.com

Bharat Serums and Vaccines Ltd
1st Floor, Building No.1, Business Development Centre, Near
Tatwagyan Vidyapeeth Ghodbunder Road, Thane (West)- 400610
Maharashtra
Address
NIL

B J Medical College Department of 25502752
and Civil Hospital Medicine, B J Medical navneetasha@yahoo.c
College and Civil om
Hospital,Asarwa,
Ahmedabad – 380 016
Ahmadabad
GUJARAT
KEM Hospital and Seth Department Of 24107545

G.S Medical College Neurology,KEM ravatsh@yahoo.com
Hospital and Seth G.S
Medical College,
Acharya Donde Marg,
Parel, Mumbai
Mumbai
MAHARASHTRA
B.J.Medical College & Department of Medicine 26128000

Sassoon General B.J.Medical College & anita.basavaraj@rediff
Hospital Sassoon General mail.com
Hospital, Pune 411 001.
Pune
MAHARASHTRA
GB Pant Hospital Professor of 011-23234350

Department of mmehndi@hotmail.com
Neurology, GB Pant
Hospital, New Delhi- 2
New Delhi
DELHI
KEM Hospital and Seth Professor and head of 022-24126766

G.S Medical College Department Of arpazare@rediffmail.co
Medicine,KEM Hospital m
and Seth G.S Medical
College, Acharya
page 2 / 5
PDF of Trial
Donde Marg, Parel,

Mumbai
Mumbai
MAHARASHTRA
KEM Hospital Research Department Of 25538904
Center Neurology, KEM anand_alurkar@yahoo.
Hospital Research co.in
Center, Sardar Moodliar
Road,Rasta Peth Pune-
4110011
Pune
MAHARASHTRA
Lokmanya Tilak Professor and Head of 24076381

Municipal Medical Department of ndmoulick@rediffmail.c
College & Lokmanya Medicine, Sion, Mumbai om
Tilak Municipal General 400022
Hospital Mumbai
MAHARASHTRA
Lokmanya Tilak Professor,Department 24076381

Municipal Medical of Neurology umasundar2@rediffmail
College & Lokmanya Services,Internal .com
Tilak Municipal General Medicaine, Lokmanya
Hospital Tilak Municipal Medical
College & Lokmanya
Hospital,Sion, Mumbai
Mumbai
MAHARASHTRA
N.D.M.V.P. Samaj Department of 2303111

Medical College Medicine, neelimachafekar@yaho
N.D.M.V.P.Samaj o.com
Medical
College,Vasantdada
Nagar, Adgaon, Nasik –
422 003
Nashik
MAHARASHTRA
Sagar Hospital Department of 80-42888888

Neurosciences, drsantoshdv@gmail.co
Jayanagar, Bangalore m
560047
Bangalore
KARNATAKA
Seth V S Hospital Professor of medicine, 9328277120

Ahmedabad - 6 stmalhan@yahoo.co.in
Ahmadabad
GUJARAT
T N Medical College & Department of 23027509

B Y L Nair Hospital Neurology, T N Medical drchakorrt@yahoo.co.in
College & B Y L Nair
Hospital Mumbai-
00008
Mumbai
MAHARASHTRA

Committee?
page 3 / 5
PDF of Trial
Date
10/02/2011
10/02/2011
Condition
Mild to Moderate Acute ischemic stroke
Other specified cerebrovascular diseases
Name Details
Kallikrein plus standard 0.15PNA (para nitroaniline)OD
supportive care X 10 Days IV
Placebo OD X 10 Days
Inclusion Criteria
18.00 Year(s)
70.00 Year(s)
Both
1. Mild to moderate cerebral ischemic strokes presenting within 
48 hours after onset of symptoms. (NIHSS score: 4-10, mild; 
11-20, moderate) 2. Male or female, aged 18 to 70 years (both
page 4 / 5
PDF of Trial
inclusive) 3. No hemorrhage as proved by cerebral CT scan

Exclusion Criteria
1. Mean arterial blood pressure > 180/110 2. NIHSS score: >21 3.
Age <18 or >70 years 4. History of dementia or neurodegenerative
disease 5. Severe comorbid condition such as cancer that would limit
survival during 3 month follow-up period 6. Women of childbearing
potential 7. Peptic ulcer disease, Active bleeding diathesis, Lower GI
bleed 8. Hematuria 9. Prolonged PT or PTT, Thrombocytopenia or
neutropenia 10. Elevated LFT / RFT
ome Timepoints
Day 90 from Day 1 of IP administration
ome Timepoints
Day 5, day 11, day 30, day 60 and day 90 from
day 1 of IP administration
nd study to determine the efficacy and
ld to moderate ischemic strokes at a dose
d in 8-10 centers in India. The primary
SS at day 5, day 11, day 30, day 60 and
ality. The secondary efficacy variables will
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:49:15 GMT)
acupressure hand- and foot- reflexology in

h AEDs alone in the management of
acupressure hand- and foot- reflexology in
h AEDs alone in the management of
nd usual drug treatment in the
Identifier
NIL
Dr Mrs Krishna Dalal
Associate Professor
All India Institute of Medical Sciences
Department of Biophysics All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
01126593215
01126588663
drkrishnadalal@gmail.com
Dr Mrs Krishna Dalal
Associate Professor
Department of Biophysics All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
01126593215
01126588663
Dr Manjari Tripathi
Department of Neurology All India Institute of Medical Sciences

New Delhi
DELHI
110029
India
01126594494
01126588663
page 1 / 5
PDF of Trial
a & Naturopathy, Department of AYUSH,
dia Material support: All India Institute of

Central Council for Research in Yoga Naturopathy
Department of AYUSH, Ministry of Health and Family Welfare ,
Government of India
Government funding agency
Address
All India Institute of Department of 01126593215

Medical Sciences Biophysics,All India 01126588663
Institute of Medical drkrishnadalal@gmail.c
Sciences-110029 om
New Delhi
DELHI

Committee?
Date
No Date Specified
Condition
Intractable epilepsy
Name Details
Reflexology therapy of 30
minutes duration twice a day in
addition to the anti-epileptic
drugs (AEDs)
Anti-epileptic drugs (AEDs) Pharmacological drugs were
assigned by the concerned
clinician
Inclusion Criteria
3.00 Year(s)
50.00 Year(s)
Both
Patients of the age group of 3 years to 50 years and both genders
had been included if they were the residents of Delhi or had some
arrangements to stay in Delhi (the centre of study), for a period of
minimum three months, and submitted of their own the filled-in
consent proforma. They had been suffering from confirmed epilepsy
with at least a frequency of 2 seizures per month, had failed 2 or
page 2 / 5
PDF of Trial
more drugs in various rational combinations over a period of 2 or

more years. They were surgical failures or were not the candidates
for surgery. They were likely to stay on the stable and adequate
doses of AEDs for a period of 3 months prior to the trial.
Exclusion Criteria
Any patient suffering from either or more of the following diseases
has been excluded from this study: malignancy of any kind, brain
tumor, encephalitis, meningitis, tuberculosis, HIV-infection, and any
kind of organ resection due to any reason.
ome Timepoints
1 year 6 months
ome Timepoints
1 year 6 months
iyan D: An integrated management of
act].Epilepsia, 50(Suppl. 11):1–502, 2009.
This randomized clinical trial was conducted to observe the efficacy of reflexology therapy in
addition to anti-epileptic drugs (AEDs) in treating patients suffering from intractable epilepsy. The
hypotheses of hand- and foot- reflexology therapy were respectively to produce results similar to
that of vagus nerve stimulations and to maintain homeostasis in the functional status among the
body parts. All the subjects taken part in this clinical trial were recruited from the out patients
department of Neurology, All India Institute of Medical Sciences (AIIMS). Training on reflexology
therapy and monitoring the therapy compliances were performed in the department of Biophysics,
AIIMS. The patients were surgically failures or not candidates for palliative epilepsy surgery or
non-responders of AEDs. Intractable epilepsy patients were defined as the subjects who had been
page 3 / 5
PDF of Trial
seizure frequency at least 2 seizures per

ptic drugs (AEDs) on adequate doses with good
group of 84 patients who had been randomly
group subjects continued on their respective
hand- and foot -reflexology therapy in addition.
were dyscognitive seizures, evolving
clonic, or tonic and clonic components) and others
e and Lennox Gastaut Syndrome. For the active
ollowing a pre-determined therapy protocol in a
months with periodic monitoring of the therapy
ogy therapy applied by their caregivers at their
ents and their caregivers were presented at the
to get the caregivers trained on a particular step
e of reflexology therapy, if there developed any
ance of the compliances. Patients were asked to
Stimulations on the reflexology areas of the
were produced by the thumb-nail of the
or 5 sessions per day with 15 stimulations of ~20
The follow-up period of each subject started from the day of 1st
irrespective of the group. During this follow-up
port at the laboratory at least once per week for
hs for a period of next 6 months; and thereafter
for the control group patients also. Though the
therapy was advised to be continued up to the
thesis of avoiding regeneration of the epileptic
mine (i) the % of reduction in seizure frequency
e baseline; and (ii) improvement in the quality of
detect the knee/lower limb pain (measured by
symptoms by the reflexology method; and
ecords on seizure frequency were collected from
Reduction in seizure frequency in both groups
Within the group, the parameters were
uality of life was assessed by using QOLIE-31
using paired sample T-test. The median seizure
roup reduced from 18(range 2-700) to 16(range
e 2-800) and 2(range 0-210) respectively. There
active group (p-value < 0.001). The pre-therapy
active groups were 41.05±7 and 43.6±8
re 49.07±6 and 65.4 ± 9. The comparative data
In the group of evolving to bilateral, convulsive
100%) was among 76.9% patients. The excellent
ng the dyscognitive seizures and other types of
was possible to detect the internal organ
on the feet and hands. The abnormalities
s, pigmentation, swelling, hollowness, scaly skin,
was not due to the misfit of foot wares). By this
up patients suffered from lower limb pain with a
% patients responded with 81% reduction in pain
viz., urinary disorders and blood pressure
alue<0.05). It was also revealed that there were
1 patient) and (iii) voice change (2 patients) that
page 4 / 5
PDF of Trial
e active group. These observations were similar

Stimulations as reported by vagus nerve
clinical trial brought out with the possibility that
together with AEDs may be useful for treating
evolving to bilateral, convulsive seizures and
dy is required to validate all the observations of
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:49:22 GMT)
apy in addition to the pharmacological

opathy
ogy in the management of patients suffering
Identifier
Other
Dr Krishna Dalal
Dept of Biophysics All India Institute of Medical Sciences

New Delhi
DELHI
110029
India
01126593215
01126588663
Dr Krishna Dalal
Head & Associate Professor

Dept of Biophysics All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
01126593215
01126588663
Dr (Mrs) Manjari Tripathi
Department of Neurology All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
01126594494
01126588663
page 1 / 4
PDF of Trial

(ICMR), New Delhi. Material support: All

Indian Council of Medical Research ICMR New Delhi
Indian Council of Medical Research P.O. Box No. 4911 Ansari Nagar
New Delhi - 110029 India
Government funding agency
Address
Department of Department of 01126593215

Biophysics, All India Biophysics,All India 01126588663
Institute of Medical Institute of Medical drkrishnadalal@gmail.c
Sciences Sciences-110029 om
New Delhi
DELHI

Committee?
Date
No Date Specified
Condition
Diabetic Neuropathy
Name Details
Reflexology therapy which will
be of 30 minutes duration twice
a day, during which the specific
reflex areas on feet are
stimulated along with the
pharmacological drugs.
Pharmacological drugs Pharmacological drugs were

assigned by the concerned
clinician
Inclusion Criteria
30.00 Year(s)
80.00 Day(s)
Both
1. Age group: any age 2. Both of sex 3. Patients who
were residents of Delhi or have arrangement for stay over Delhi for a
minimum duration 1 month. And during the follow-up period, the
proper correspondence should be available to the laboratory for
getting the information about their health status. This is
required for monitoring their health in response to reflexology. 
4. Patients who have signed in informed consent proforma 5.
page 2 / 4
PDF of Trial
Patients with Blood sugar level: greater than or equal to

120mg/decilitre(Fasting) and greater than or equal to 200mg/deciliter
(post prandial) for more than 1 occasion 6. Patients with
documented peripheral diabetic neuropathy.
Exclusion Criteria
1. Patients non-resident of Delhi or not having any arrangement to
stay in Delhi during the training period which was 2½ months -3
months 2. Patients with end organ damage (viz., gangrene, toes or
foot amputation) due to diabetes/any cause 3. Patients not willing to
sign informed consent from 4. Patients suffering from
over-neuropathy 5. Patients with other chronic disorders like
malignancy, T.B., asthma or any communicable disease.
ome Timepoints
6 months
ome Timepoints
6 months for all the secondary outcome
measures

page 3 / 4
PDF of Trial
armed, randomized, parallel group clinical trial was conducted to determine the effect of
Reflexology in addition to the pharmacological drugs for managing patients suffering from peripheral
uropathy associated with diabetes mellitus. The patients were selected for this trial following the
tients selection criteria and the ethical norms of the All India Institute of Medical Sciences. They
e referred by the Outpatient Departments of Neurology & Endocrinology, All India Institute of
Medical Sciences. A sample size of 71 patients of both genders were recruited during the year 2006
9 for this trial. The intervention therapy (Reflexology) procedure was performed in the
rtment of Biophysics. A group of 18 patients was withdrawn from the trial. Thus the study
up contains a sample size of 29 [mean age in years (mean ± SD) 56.75 ± 9.65 and duration of
iabetes in years (median (range)) 10 (3-28) and duration of neuropathy in years (median (range)) 3
.5-8)]. The control group is comprised of sample size 29 [mean age in years (mean ± SD) 55.89 ±
21 and duration of diabetes in years (median (range)) 13 (4-30) and duration of neuropathy in
ears (median (range)) 6 (2-14)]. The sample size of this trial was calculated anticipating 20% mean
uctions in neuropathy in the study group patients compared with the conventional one with 5%
of significance and 80% power. Using statistical analysis software STATA 9.0 (College
tion, Texas, USA) the sample size was estimated to be 25 per group. We studied a sample size
er group assuming 10% lost to follow up. Reflexology therapy was applied with the
othesis that it would bring back and maintain homoeostasis amongst the internal body organ
ctions, harmonize all the endocrine glands functions and rectify the symptoms associated with
betes. The working principle of the acupressure foot reflexology is that by applying mechanical
mulations in the form of momentary pressure and relaxation on specific areas on the feet, one is
o rectify the internal organs functions. With this hypothesis, a predetermined reflexology
otocol was applied to treat the study group patients holistically. Reflexology therapy was applied
eir own caregivers who got trained in the reflexology technique. For this purpose, an initial
of 2 ½ -3 months was devoted to train the caregivers with periodic monitoring of their
rformances. Reflexology was applied 3 sessions per day, each session of ½ hour duration. At the
mpletion of training, therapy was applied 2 sessions per day for a further period of 3 months. The
on of the trial was 6 months for both the groups. All the data were recorded for both the
s at the pre- and post- therapy stages. The reflexology data for detecting the abnormal
ons of the internal organs were recorded for the study group patients only. The primary
come measure of this trial was the pain score measured by Visual Analogue Scale (VAS) in the
of 0 to 10, where 0 indicates no pain and 10 indicates excruciating pain. The secondary
ome measures were the Quality of life in neuropathy measured by neuroQOL. The objective
meters recorded are (i) blood sugar level (both fasting and pp) (ii) glycosylated HbA1c, (iii)
pressure, (iv) frequency of urination, (v) nerve conduction velocity (NCV), (vi) vibration
nsitivity and (vii) thermal sensitivity. The subjective parameters were measured using standard
estionnaire and these include (i) numbness in the legs / feet, (ii) tingling sensation, (iii) burning
on, (iv) difficulty in walking and (v) difficulty in standing. All these data were analyzed
istically using students t- test, Chisquare test / Fishers exact test with the software STATA 9.0
llege station, Texas USA). The VAS pain score was found to be 61.48% and 34% improvement
study and control group patients respectively with a p-value of 0.001. There are 53%
rovements in Quality of Life in neuropathy for the study group patients with a p-value of 0.001.
e was marked improvement in all other parameters as mentioned above in the study group
nts when compared with the control group ones, with statistically highly significant values
alue < 0.001). The observations on the pre- and post- therapy data of the reflexology features
z., tenderness, hollowness formation, abnormal pigmentation, swelling, corn formation, etc on the
(if it is not due to unfit of the shoes), led to conclude on the functional status of the internal
gans. This is an important observation of this trial which may be used for diagnose the abnormal
ed ailment(s).
page 4 / 4
PDF of Trial
un, 08 Jan 2023 04:49:29 GMT)
cts with Multiple Sclerosis who have
the safety and efficacy of DAC HYP in

atment in study 205MS201 (SELECT).
Identifier
EudraCT
Protocol Number
ClinicalTrials.gov
Nitya Pandita
Clinical Trial Lead
Biogen Idec Biotech India Pvt. Ltd. Vatika Towers, B Block, 12th
Floor, Sec 54, Golf Course Road
Gurgaon
HARYANA
122002
India
01244572349
911244572370
nitya.pandita@biogenidec.com
Dr Anjali Nagpal
Senior Scientific Advisor

Floor, Sec - 54, Golf Course Road
Gurgaon
HARYANA
122002
India
01244572343
01244572370
anjali.nagpal@biogenidec.com
Nitya Pandita
Clinical Trial Lead
Floor, Sec 54, Golf Course Road,
Gurgaon
HARYANA
page 1 / 5
PDF of Trial
122002
India
01244572349
01244572370
nitya.pandita@biogenidec.com
nhead Berkshire SL4 6A
Biogen Idec
Address
Fortis Escorts Hospital Jawahar Lal Nehru drrajaram195@rediffma

Marg ,Malviya Nagar il.com
,-302 017
Jaipur
RAJASTHAN
King George Hospital Dept. of mythmedi@satyam.net.

Neurology,Rajendra in
Prasad Ward,-530002
Not Applicable
N/A
Nizam's Institute of Department of meenaak@hotmail.com

Medical Sciences Neurology, Panjagutta
,-500082
Hyderabad
ANDHRA PRADESH
Sri Aurobindo Seva 1-H Gariahat Road pahari_ghosh@vsnl.net

Kendra, Department of (South),-700068
Neurology, Kolkata
WEST BENGAL
St Johns Medicial Department of royajit@hotmail.com

Hospital Neurology Kormangala
,-560034
Bangalore
KARNATAKA

Committee?
page 2 / 5
PDF of Trial
Date
03/09/2010
Condition
Relapsing Remitting Multiple Sclerosis
Name Details
DAC HYP a) DAC HYP 150 mg SC every
4 weeks for a total of 13
doses.b) DAC HYP 300 mg SC
every 4 weeks for a total of 13
doses.c) Placebo SC every 4
weeks for a total of 5 doses
followed by DAC HYP 150 mg
SC every 4 weeks for a total of
8 doses.d) DAC HYP 150 mg
13 doses.e)Placebo SC every 4
8 doses.f) DAC HYP 300 mg
13 doses.
DAC HYP a) DAC HYP 150 mg SC every
4 weeks for a total of 13
doses.b) DAC HYP 300 mg SC
every 4 weeks for a total of 13
doses.c) Placebo SC every 4
8 doses.d) DAC HYP 150 mg
13 doses.e)Placebo SC every 4
8 doses.f) DAC HYP 300 mg
13 doses.
NIL There is no control intervention

in the trial.
Inclusion Criteria
page 3 / 5
PDF of Trial
18.00 Year(s)
55.00 Year(s)
Both
1. Ability to understand the purpose and risks of the study and
provide signed and dated informed consent and authorization to
use protected health information (PHI) in accordance with
national and local subject privacy regulations. 2. Must be a
subject from Study 205MS201 for at least 52 weeks and must have
been compliant with the 205MS201 protocol in the opinion of
the Investigator. 3. All male subjects and female subjects of
childbearing potential must practice effective contraception
during the study and be willing and able to continue 
contraception for 4 months after their last dose of study treatment.
For further details of contraceptive requirements for this study
Exclusion Criteria
1. Subjects with any significant change in their medical status from
Study 205MS201 that would preclude administration of DAC HYP
including laboratory results or a current clinically-significant condition
that, in the opinion of the Investigator, would have excluded the
subject?s participation in Study 205MS201. The Investigator must
re-review the subject?s medical fitness for participation and must
consider any diseases that would preclude treatment with DAC HYP.
2. Any subject who has permanently discontinued study treatment in
Study 205MS201 except subjects who were unblinded during
evaluation of an adverse event (AE) and found to be on placebo. 3.
Planned ongoing treatment with any approved or experimental
treatment for MS except for the protocol-allowed use of concomitant
IFN-beta. 4. Current enrollment in any investigational drug study
other than 205MS201. 5. Unwillingness or inability to comply with the
requirements of the protocol, including the presence of any condition
(physical, mental, or social) that is likely to affect the subject's ability
to comply with the protocol. 6. Other unspecified reasons that, in the
opinion of the Investigator or the Biogen Idec Medical Director, make
the subject unsuitable for enrollment.

ome Timepoints
After the patient completes week 52 in study
205MS201
ome Timepoints
After the patient completes week 52 in study
205MS201.
page 4 / 5
PDF of Trial
y from study 205MS201 in order to evaluate
C HYP in multiple sclerosis. Globally as of
udy out of the 621 patients who had been
ent in India is expected to be Jan 2011.
n India. The first patient is expected to be
ent period in India will be from Jan 2011 to
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:49:37 GMT)
in Patients With Partial Onset Seizures

cebo-controlled Efficacy and Safety Study
ministrated orally three times daily (TID) as
ures
cebo-controlled Efficacy and Safety Study
ministrated orally three times daily (TID) as
ures
Identifier
Protocol Number
ClinicalTrials.gov
Not Applicable
N/A
India

Dr. Kamala Rai
Novartis Healthcare Private Limited, Medical Department, Sandoz

House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India
022 -24958533
022 -24954112
kamala.rai@novartis.com
Dr. Kamala Rai

Mumbai
MAHARASHTRA
400 018
India
022 -24958533
page 1 / 6
PDF of Trial
022 -24954112

Novartis Health care Private Limited
Novartis India Limited 5th Floor, Sandoz House, Dr Annie Beseant
Road, Worli,Mumbai- 400018
Address
Brain and Mind Institute B-101, Neeti Gaurav 0091-712-2428701

Complex,Central 0091-712-2451626
Bazaar Road,
Ramdaspeth-440010
Nagpur
MAHARASHTRA
Curie Manavata Cancer Opp. Mahamarg Bus 0091-253-2592666

Centre stand,Mumbai 0091-253-2318993
Naka-422 004 mngulhane@hotmail.co
Not Applicable m
N/A
Indian Epilepsy Centre D-61 0091-11-2653 4465

Hauz-Khas,-110016 0091-11-2653 4464
New Delhi satjain55@hotmail.com
DELHI
Poona Hospital and Department of 9822719440

Research Centre Neurology, 27,Sadashiv 0091-20-24320681
Path- sudhirkothari@gmail.co
Pune m
MAHARASHTRA
Sir GangaRam Hospital Department of 0091- 11-42251439

Neurology, 4th 0091-11-45041726
Floor,Old Rajinder rohatgianshu@yahoo.c
Nagar,-110 002 om
New Delhi
DELHI
St. John's Medical Department of 0091-80 22065000

College Hospital Neurology,,Sarjapur 0091-80-25634479
Road,-560 034 rroy_ajit@hotmail.com
Bangalore
KARNATAKA
Vidyasagar Institute of No.1 Institutional 0091-11 29849035
Mental Health and Area,Nehru Nagar,-110 0091-11-29849036
Neuro-Sciences 065 sdclinical@gmail.com
(VIMHANS) New Delhi
DELHI

Committee?
page 2 / 6
PDF of Trial

Review

Review

Review

Review

Review
Date
03/08/2010
Condition
Name Details
BGG492 50 microgram immediate
release capsule
BGG492 5 microgram immediate release
capsule
Placebo Capsule
Inclusion Criteria
18.00 Day(s)
65.00 Day(s)
Both
1.Male and female outpatients age 18 to 65 years (inclusive) 2.
Are of greater than or equal to 50 kg (110 lb) of weight 3. Have
a diagnosis of epilepsy (greater than or equal to 2 years prior to
screening) with partial seizures with or without secondarily
generalized seizures according to the International League
Against Epilepsys Classification of Epileptic Seizures (ILAE,
1981) Appendix 5 The Diagnosis should have been
established by clinical history and electroencephalogram (EEG)
that is consistent with localization related epilepsy. Must have
had either a computed tomography (CT) or magnetic resonance
imaging (MRI) within the 5 years prior to screening that ruled
out progressive neurological changes (e.g. Alzheimer’s
disease, Parkinson’s disease, Multiple Sclerosis); in addition, no
physical examination changes suggestive of such lesions or
diseases should have occurred since the imaging
procedure; If a patient has not had a CT or MRI within the past
5 years, then a MRI must be performed during the screening
period and the results must be reviewed for compliance with
above criterion prior to randomization; 5. Must have
uncontrolled partial seizures despite having been treated with at
least two different anti-epileptic drugs within the last 2 years
prior to screening (given concurrently or sequentially); 6.
page 3 / 6
PDF of Trial
Must have at least 4 partial seizures (defined as simple partial
seizures with motor signs, 7. complex partial seizures, complex
partial seizures with secondary generalization or a combination
of these types) during the 4-week prospective baseline period and
the 4 weeks immediately preceding the baseline period
(retrospective and/or prospective data) 7. Have no 28 day
seizure free period during the 8 weeks preceding randomization 
8. Must be receiving stable treatment (see inclusion criteria 8.1 8.4
and 9) with 1 or a maximum of 2 AEDs from the list presented
below: 8.1 No change in medication type, dose or frequency for
8 weeks prior to randomization: Carbamazepine,
Eslicarbazepine, Oxcarbazepine, Phenytoin, Valproate,
Lacosamide, Lamotrigine, Levetiracetam, Clobazam,
Topiramate, Zonisamide, Gabapentin and Pregabalin 8.2
No change in medication type, dose or frequency for 12 weeks prior
to randomization: Phenobarbital and Primidone 8.3 Vagal
nerve stimulation (VNS) will be counted as 1 AED 8.4 Stable
benzodiazepine treatment (no change in medication type, dose, or
frequency for 12 weeks prior to randomization) administered for
e.g. epilepsy, anxiety, or sleep disorders will be counted as one
AED Note: The use of intermittent benzodiazepines is defined
in exclusion criteria 2.5 refer to Section 4.2. 9. If using a
vagal nerve stimulator, the device must have been implanted for at
least 22 weeks prior to randomization. Stimulator parameters
may not have been changed within 8 weeks prior to
randomization 10. Patients having had pre-surgical evaluations
may be included. Also, patients having had brain surgery for
partial seizures may be included, if surgery was performed greater
than or equal to 1 year before randomization 11. Are on
stable doses (constant for 4 weeks prior to randomization) of
non-AED concomitant medication 12. Have a history
of taking his or her medication(s) as directed (determined by
direct questioning of patient, caregiver and or investigator
knowledge of prior compliance problems if the patient had been
under the investigator’s care prior to the study) 13. Are reliable
and willing to make themselves available for the study period and are
able to record seizures and report adverse events themselves
or have a caregiver (parent, legal guardian) who can record and
report the events for them; 14. Have provided written informed
consent before any assessments are performed. 
Exclusion Criteria
Any of the following seizure conditions:
1.1 Presence of only non-motor simple partial seizures
1.2 History of psychogenic seizures
1.3 Absences, myoclonic seizures e.g. in the context of primary
generalized epilepsy
1.4 Previous history of Lennox-Gastaut syndrome
1.5 History of status epilepticus or seizure clusters (where individual
seizures cannot
be counted according to the judgment of the investigator) occurring
within 52
weeks prior to randomization
1.6 Only seizures caused by an underlying medical illness during the
52 weeks prior to
randomization
2. Have been treated with
2.1 Felbamate, unless treatment has been continuous for greater
than or equal to 2 years
2.2 Vigabatrin during the 26 weeks prior to randomization
2.3 Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants
page 4 / 6
http://ctri.nic.in
page 5 / 6
PDF of Trial
US only: and estradiol less than 20 pg per mL]
or have had surgical bilateral oophorectomy (with or without
hysterectomy) at least six
weeks ago. In the case of oophorectomy alone, only when the
reproductive status of the
woman has been confirmed by follow up hormone level assessment
is she considered not
of child bearing potential.
8. Any of the following cardiovascular conditions
8.1 Myocardial infarction and or cerebrovascular accident (CVA or
stroke) within 26
weeks prior to screening
8.2 History of or unstable angina pectoris at Screening or Baseline
8.3 Hypertension uncontrolled by medication (defined as supine
systolic blood
pressure greater than or equal to 160 mmHg, or diastolic blood
pressure greater than or equal to 100 mmHg) at screening or
baseline or if re-assessed as abnormal according to the above stated
limits at prior
to initial dosing on Day 1
ome Timepoints
28 days
ome Timepoints
28 days

a is 23 Sep 2010.
page 6 / 6
PDF of Trial
un, 08 Jan 2023 04:49:44 GMT)
rial is to study efficacy, safety and

fil Tablets (reference product).
and non-crossover, multicentric, clinical
with Erectile Dysfunction.
Identifier
Protocol Number
Dr Shailesh Singh
Associate Vice President DRA and R&D
Ajanta Pharma Ltd, Advent
Ajanta Pharma Ltd, Advent 43/44,ABCD,Charkop Industrial Estate,
Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India
022-66062112
022-66062100
shaileshs@ajantapharma.com
Dr Shailesh Singh
Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India
022-66062112
022-66062100
Dr Shailesh Singh
Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India
page 1 / 4
PDF of Trial
022-66062112
022-66062100

Ajanta Pharma Ltd
Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Address
NIL

Dr. Milind Kirloskar?s 105, Amar Arcade, 09322106422
Clinic Sadhu Vaswani mskirloskar@yahoo.co
Road,Kulkarni m
Colony-422 002
Nashik
MAHARASHTRA
Dr. Mishra's Clinic Dakabangala,Old dr.kpmishra@rediffmail.

town-751004 com
Not Applicable
N/A
Gaikwad Nursing Home 132, ,Samarth 09822038892

Nagar-431001 sbg.2007@rediffmail.co
Aurangabad m
BIHAR
Ishaan Urology Centre Gr. Floor, Surya-Sagar 09823033684

Bldg., ,Opp. urodev@gmail.com
Vidyavardhini Engg.
College, Behind
Gurudwara, Vasai (W),
-401202
Thane
MAHARASHTRA

Committee?
Date
page 2 / 4
PDF of Trial
16/12/2010
Condition
Erectile Dysfunction
Other male erectile dysfunction
Name Details
Name Details
Vardenafil Tablets (Starting dose is 10 mg taken
orally approximately 60 minutes
before sexual activity. The dose
may be increased to a
maximum recommended dose
of 20 mg or decreased to 5 mg
based on efficacy and side
effects. The maximum
recommended dosing frequency
is once per day) for period of 12
week
Tadalafil Tablets (Starting dose of tadalafil is 10

mg, taken prior to anticipated
sexual activity. The dose may
be increased to 20 mg or
decreased to 5 mg, based on
individual efficacy and
tolerability. The maximum
recommended dosing frequency
is once per day) for period of 12
week
Inclusion Criteria
18.00 Year(s)
60.00 Year(s)
Male
1.Availability of subjects for the entire study period and willingness to
adhere to protocol requirements as evidenced by written informed
consent. 2.Patient with history, signs & symptoms of Erectile
Dysfunction (Inability to attain an erection, Inability to sustain an
erection, Painful erection, penile pain)
Exclusion Criteria
1. Male < 18 years of age 2. Female 3. History of hypersensitivity to
the study drug or related products. 4. Significant history or presence
of gastrointestinal, liver or kidney disease, or any other conditions
known to interfere with the absorption, distribution, metabolism or
excretion of common medications. 5. Patients with hypogonadism or
anatomical deformities such as severe penile fibrosis. 6. Any clinical
significant illness during the 4 weeks prior to day 1 of this study. 7.
Participation in a clinical trial with an investigation drug within 30
days proceeding day 1 of this study. 8. Any condition that, in the
opinion of the investigator, does not justify the patient?s inclusion in
the study.

ome Timepoints
Day 1, week 4, week 8 and week 12.
page 3 / 4
PDF of Trial
ome Timepoints
Day 1, week 4, week 8 and week 12.
rallel group, and non-crossover,

afil Tablets in 200 Men with Erectile
10.
ndex of Erectile Function (IIEF 5)
ssessed by Sexual Encounter Profile
page 4 / 4
PDF of Trial
un, 08 Jan 2023 04:49:50 GMT)
Subjects With Neuropathic Pain Associated
Identifier
Protocol Number
ClinicalTrials.gov
Swapnali Raut
Mumbai
MAHARASHTRA
400 102
India
91-9821415224
91-022-26525993
Swapnali Raut
Mumbai
MAHARASHTRA
400 102
India
91-9821415224
91-022-26525993
Swapnali Raut
page 1 / 5
PDF of Trial
Mumbai
MAHARASHTRA
400 102
India
91-9821415224
91-022-26525993
Jogeshwari West, Mumbai 400 102 India
Pfizer Limited
Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai
400 102, India
Address
Nil
Deenanath Mangeshkar Erandawane,-411004 +91-20-66023000 (Extn

Hospital and Research Pune 1059)
centre MAHARASHTRA +91-20-66023107
rahulneuro@vsnl.net
Infectious Disease 3rd Floor, Vedanta +91-79-26440816

Clinic Institute of Medical +91-79-26422743
Sciences,Stadium to atulpatel65@gmail.com
commerce Six Road,
Navrangpura-380009
Not Applicable
N/A
Jaslok Hospital and Department of HIV +91-22-23680288

Research Centre Medicine,15,Dr. G. +91-22-23523504
Deshmukh jkmaniar@vsnl.com
Marg-400026
Mumbai
MAHARASHTRA
Mahavir Hospital and 10 -1-1, Bhagwan +91-40-2379392
Research Centre Mahavir Marg,A. C. +91-40-23320447
Guards, srinivaskulkarni_dr@re
Masabtank-500004 diffmail.com
page 2 / 5
PDF of Trial
Hyderabad
ANDHRA PRADESH
Sanjay Gandhi Department of 91-522-2494181
Postgraduate Institute Neurology Raebareli drukmisra@rediffmail.c
of Medical Sciences, Road Lucknow, 226 om
014
Lucknow
UTTAR PRADESH
Surakshaka MIG-218, KPHB Main +91-40-23151000

Multispeciality Hospital Road,,Kukatpally-500 +91-40-40061930
072 surakshakadiacarehyd
Hyderabad @gmail.com
ANDHRA PRADESH
YR Gaitonde Centre for Unit of Y R +91-44-22542929

AIDS Research and Gaitonde,Medical +91-44-22542939
Education Educational and kumarasamy@yrgcare.
Research Foundation, org
Voluntary Health
Services, Taramani-600
113
Chennai
TAMIL NADU

Committee?
Date
26/08/2010
Condition
Neuropathic pain associated with HIV
Neuropathy
Name Details
Pregabalin (Lyrica): Drug: pregabalin (Lyrica) 150
Experimental mg-600 mg/day (twice daily).
page 3 / 5
PDF of Trial
The total duration of the study

and treatment is 175 days.
Nil NIL
Inclusion Criteria
18.00 Year(s)
99.00 Year(s)
Both
1. Subjects who participated in the preceding A0081244 double-blind
trial and completed at least through Visit 9 of that trial. 2.
Subjects with painful distal sensory polyneuropathy (DSP) interested
in treatment based on investigator clinical judgment. 3. Subjects
who had acceptable tolerability of study drug in A0081244. 
Note: There is no upper age limit criteria per the protocol 
Exclusion Criteria
1. Clinically significant or unstable conditions that, in the opinion of
the investigator, would compromise participation in the study. This
includes, for example, medical conditions such as, but not limited to:
hepatic, renal, respiratory, hematological, immunological,
cardiovascular diseases, arrhythmia, inflammatory or rheumatologic
disease, active infections, symptomatic peripheral vascular disease,
psychiatric illness, and untreated endocrine disorders. 2. Other
severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study
participation or investigational product administration or may interfere
with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this
study. 3. Active Acquired Immune Deficiency Syndrome (AIDS)-
defining Opportunistic Infection (OI) that requires hospitalization.
ome Timepoints
6 months
ome Timepoints
6 months
6 months
6 months
6 months
6 Months
6 Months

page 4 / 5
PDF of Trial
A0081244 (CTRI2010/091/001319) to
europathic Pain Subject completing
er in the A0081251 extension study.
g to 300 mg BID Pregabalin daily.
d trial, subjects who meet all inclusion
ast Visit 9 of study A0081244 have the
open-label conditions for 6 months.
open-label treatment at 150 mg/day (75
thin the dose range 150-600 mg/day
subjects’ individual response and
efficacy and safety assessments at
here will also be a phone visit 2 weeks
sess for adverse events and potential
e a 1-week taper and return for a final
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:49:57 GMT)
nt in Patients With Refractory Partial Onset

nt in Patients With Refractory Partial Onset
ed Exploratory Study to Assess the

ve Treatment in Patients With Refractory
Identifier
Protocol Number
ClinicalTrials.gov
Not Applicable
N/A
India

Dr. Kamala Rai

Mumbai
MAHARASHTRA
400 018
India
022 -24958533
022 -24954112
Dr. Kamala Rai

Mumbai
MAHARASHTRA
400 018
India
page 1 / 5
PDF of Trial
022 -24958533
022 -24954112

Novartis Health care Private Limited
Sandoz House, 5th floor Shivsagar Estate Dr. Annie Besant Road
Worli, Mumbai 400 018 INDIA
Address
CARE Hospital Dept of Neurology, 9701700090

Exhibition Grounds 0091-40-66835559
Road,,Nampally,-500 jmkmurthy@satyam.net
001 .in
Hyderabad
ANDHRA PRADESH
Dayanand Medical Tagore Nagar Civil 0161-4687320

College & Hospital Lines,-141 001 0091-161-2308383
Ludhiana mbansal78@rediffmail.
PUNJAB com
Deenanath Mangeshkar Dept. of 9822012588

Hospital and Research Neurology,Erandwane 0091-20-66023107
Center -411 004 rahulneuro@gmail.com
Pune
MAHARASHTRA
G. B. Pant Hospital Dept of Neurology, 9718599303

Room No 502, 0091-11-23234350
,Academic Block,-110 mmehndi@hotmail.com
002
New Delhi
DELHI
Krishna Institute of 1-8-31/1, Minister 9848019036

Medical Sciences Road,,-500 003 0091-40-27840980
Not Applicable sita_js@hotmail.com
N/A
M S Ramaiah Memorial Department of 9448040589
Hospital , Neurology ,,New BEL 0091-80-40528402
Road, MSRIT Post -560 drrsrinivasa@hotmail.c
054 om
Bangalore
KARNATAKA
Mallikatta Neuro Centre Opp Mallikatta 0824-2444933

Circle,Kadri-575 002 0091-824-4255925
KARNATAKA om
Sawai Man Sing Dept of 09414075120

Hospital Neurology,,Jawaharlal 0091-14-12570504
Nehru Marg, -302 004 sharma.drbhawna@gm
page 2 / 5
PDF of Trial
Jaipur ail.com
RAJASTHAN
Committee?
Review
Review

Review

Review
Review

Review
Review
Date
21/09/2010
Condition
Name Details
BGG492 5 milligram
BGG492 50 milligram
Placebo Comparator Placebo
Inclusion Criteria
18.00 Day(s)
65.00 Day(s)
Both
Male and female outpatients age 18 to 65 years (inclusive) 2.
Weight of greater than or equal to 50 kg (110 lb) 3. Have a
diagnosis of epilepsy (more than 2 years before screening) with
partial seizures with or without secondarily generalized seizures
according to the International League Against Epilepsys
Classification of Epileptic Seizures (ILAE, 1981) Appendix 5 
The Diagnosis should have been established by clinical history and
electroencephalogram (EEG) that is consistent with localization
related epilepsy 4. Must have at least 4 partial seizures (defined
as simple partial seizures with motor signs, complex partial
seizures, complex partial seizures with secondary generalization or
a combination of these types) during the 4 week baseline
page 3 / 5
PDF of Trial
period and the 4 weeks immediately preceding the baseline
period 5. Have no 28day seizurefree period during the 8 weeks
preceding randomization 6. Must have a positive test result for
iGluR3 antibodies in the blood at screening. The mean plus
three standard deviations derived from healthy donors will be chosen
as cutoff value. 7. Must have uncontrolled partial seizures
despite having been treated with at least two different
antiepileptic drugs within the last 2 years prior to screening (given
concurrently or sequentially) 8. Must be receiving stable
treatment (see inclusion criteria 8.1 to 8.4 and 9) with 1 or a 
maximum of 2 AEDs from the list presented below: 8.1 No
change in medication type, dose or frequency for 8 weeks prior
to randomization: Carbamazepine, Eslicarbazepine,
Oxcarbazepine, Phenytoin, Valproate, Lacosamide,
Lamotrigine, Levetiracetam, Clobazam, Topiramate, 
Zonisamide, Gabapentin and Pregabalin. Felbamate is only allowed,
if treatment has been continous for greater than or equal to 2
years. 8.2 No change in medication type, dose or frequency for
12 weeks prior to randomization Phenobarbital and
Primidone 8.3 Vagal nerve stimulation (VNS) will be counted as
1 AED. If using a vagal nerve stimulator, the device must have
been implanted for at least 5 months prior to randomization.
Stimulator parameters may not have been changed within 8
weeks prior to randomization 8.4 Stable benzodiazepine
treatment (no change in medication type, dose, or frequency for
12 weeks prior to randomization) administered for e.g. epilepsy,
anxiety, or sleep disorders will be counted as one AED 
Note: The use of intermittent benzodiazepines is defined in the
exclusion criteria 2.5, refer to Section 4.2. 9. Must have
had either a computed tomography (CT) or magnetic resonance
imaging (MRI) within the 5 years prior to screening that ruled
out progressive neurological changes (e.g. Alzheimer’s
disease, Parkinson’s disease) in addition, no physical examination
changes suggestive of such lesions or diseases should have
occurred since the imaging procedure If a patient has not had a
CT or MRI within the past 5 years, then a MRI must be 
performed during the screening period and the results must be
reviewed for compliance with above criterion prior to
randomization 10. Patients having had pre-surgical evaluations
may be included. Also, patients having had brain surgery for
partial seizures may be included, if surgery was performed greater
than or equal to 1 year before randomization 11. Are on
stable doses (constant for 4 weeks prior to randomization) of non
AED concomitant medication Have a history of taking
his/her medication(s) as directed (determined by direct 
questioning of patient, caregiver and or investigator knowledge of
prior compliance problems if the patient had been under the
investigators care prior to the study) 13. Are reliable and willing
to make themselves available for the study period and are able
to record seizures and report adverse events themselves or
have a caregiver (parent, legal guardian) who can record and
report the events for them 14. Have provided written informed
consent before any assessments are performed.
Exclusion Criteria
* Presence of only non-motor simple partial seizures * History of
psychogenic seizures * Absences, myoclonic seizures e.g. in the
context of primary generalized epilepsy; * Previous history of
Lennox-Gastaut syndrome *Pregnant or nursing (lactating) women *
Status epilepticus or seizure clusters, according to the judgement of
the investigator, occurring within 52 weeks prior to randomization
page 4 / 5
PDF of Trial
ome Timepoints
28 days
ome Timepoints
12 weeks
10 weeks
28 days

V from India is 11th November 2010. No
page 5 / 5
PDF of Trial
un, 08 Jan 2023 04:50:06 GMT)
toprofen Trometamol and Dicyclomine
ose Combination of Dexketoprofen

he treatment of Acute Colicky Pain
Identifier
Protocol Number
Dr. Onkar Swami, MD
Emcure Pharmaceuticals Ltd. Rajiv Gandhi IT Park Phase I, MIDC
Pune
MAHARASHTRA
411057
India
020-39821000
020-39821019
Dr. Onkar Swami, MD

Pune
MAHARASHTRA
411057
India
020-39821000
020-39821019
Dr. Onkar Swami, MD

Pune
MAHARASHTRA
411057
India
020-39821000
020-39821019
page 1 / 7
PDF of Trial

Emcure Pharmaceuticals Ltd. Pune
Address
Abhinav Multispeciality Kamal Chowk,Naya

Hospital Nakasha-440017
Nagpur
MAHARASHTRA
Chest Research Centre 2 Janki Nagar Extensio

n,Valasaravakkam-600
087
Chennai
TAMIL NADU
Department of Surgery Dr. Shankarrao Chavan 09860951000

Govt. Medical College prashantshirure@yahoo
and Hospital,Vazirabad- .com
431601
Nanded
MAHARASHTRA
Department of Surgery Karnatak Institute of 09448110403

KIMS Medical kamatvv@gmail.com
Science,Bengeri Road,
Keshwapur-580023
Not Applicable
N/A
Giridhar Clinic Oshiya corner

building,,Sukhsagar
Nagar,-411046
Pune
MAHARASHTRA
Ketki Hospital Plot No. 477, N-3,

CIDCO,,Near Kamgar
Chowk, Opp. to Chate
House,-431001
Aurangabad
BIHAR
Modern Stone Care & 434/10 Saraja Vaibhav,

Urology Research 1st Foor,Opp. Tathe
Centre Hospital, Shaniwar
Peth-415110
Not Applicable
N/A
Pawana Hospital Somatane Phata, ,Tal ?

Maval-410507
Pune
MAHARASHTRA
page 2 / 7
PDF of Trial
Prabha Vithal Clinic 166/FNM Shivaji drjagdishkeny@rediffm

Nagar,SION ail.com
(E)-400022
Mumbai
MAHARASHTRA
Prabhavati Ambajaogai enadle@msn.com
Multispeciality Hospital Road,,Latur-431512
and Reserch Centre Latur
MAHARASHTRA
Ram Krishna Mission LUXA,- 09935036063

Hospital Varanasi dribasumd@yahoo.co.i
UTTAR PRADESH n
Sai Urology Hospital Plot No. 1, Vishal

Nagar, Gajanan Mandir
Road,,-431005
Aurangabad
BIHAR
Sengupta Hospital and Ravi Nagar,-440033

Research Institute Nagpur
MAHARASHTRA
Sevadham Hospital Talegaon Dabhade,
,Talegaon Dabhade
station-410506
Pune
MAHARASHTRA
Sharada Clinic 408/1 Ghorpade drashwinporwal@rediff

Peth,Ekbote Colony- mail.com
Pune
MAHARASHTRA
Sharada Clinic, Erram Near Krishna 02164-222440

Hospital Bridge,Station subhasherram@hotmail
Road-415110 .com
Not Applicable
N/A
Shashwat Hospital Happy Colony, Near

Janta Sahakari Bank,
Gandhi Bhavan,,Kothru
d-411038
Pune
MAHARASHTRA
Shree Hospital Nagar Road ,-411006 020-26681127
Pune sdhorepatil@gmail.com
MAHARASHTRA
Surgical Hospital Opp Municipal School,
Nr. Vishvakunj
Society,,Narayan Nagar
Road, Paldi,-380007
Ahmadabad
GUJARAT
Walvekar Hospital Opp Garpir,6th lane,

Ganesh
Nagar,,-416416
Sangli
MAHARASHTRA

Committee?
page 3 / 7
PDF of Trial

page 4 / 7
PDF of Trial

Date
No Date Specified
Condition
Acute Renal Colic
Name Details
FDC of Dexketoprofen Single deep intramuscular
trometamol 50 mg + injection
Dicyclomine hydrochloride 20
mg injection
FDC of Diclofenac 50 mg + Single deep intramuscular
Dicyclomine hydrochloride 20 injection
mg injection
page 5 / 7
PDF of Trial
Inclusion Criteria
1.Male and female patients between 18 to 65 years of age 2.Patients

presenting with acute colicky pain in the flank and/or radiating to the
abdomen or genitalia. 3.Moderate to severe pain on Visual Analogue
Scale (VAS ≥ 40 mm) 4.Patients willing to give written
informed consent and willing to comply with trial protocol
Exclusion Criteria
1.Patients with known hypersensitivity to the study medications and
/or history of any drug allergy or intolerance to NSAIDs or any
anesthetic medication. 2.Patients on any anti-inflammatory or other
therapy known to affect the study outcome. 3.Patients with active or
suspected gastrointestinal ulcer/ history of gastrointestinal ulcer/
chronic dyspepsia or gastrointestinal bleeding. 4.Patients with known
Crohn?s disease or ulcerative colitis 5.Patients with history of
bronchial asthma 6.Patients with known severe heart failure/
moderate to severe renal dysfunction (Creatinine clearance < 50
ml/min.) or severely impaired hepatic function (Child- Pugh score 10-
15) 7.Patients with hemorrhagic diathesis and other coagulation
disorders 8.Any contraindication to use of NSAID 9.Drug addiction or
alcoholism 10.Patients with diagnosed gastrointestinal obstruction
11.Patients with known myasthenia gravis 12.Patients with known
glaucoma 13.Patients with any significant and uncontrolled
hematological / metabolic /endocrinological (excluding type 2
diabetes mellitus) / neurological / psychiatric / respiratory /
cardiovascular disorder 14.Women who are pregnant, lactating, or of
child bearing potential who are not practicing effective methods of
contraception. 15.Any condition that, in the opinion of the
investigator, does not justify the patient?s inclusion in the study.
ome Timepoints
At the intervals of 1, 2, 4, 6 and 8 hours after the
injection
ome Timepoints
Baseline and at the intervals of 1, 2, 4, 6 and 8
hours after the injection

page 6 / 7
PDF of Trial
linical trial is planned to compare the

50 mg and dicyclomine hydrochloride 20
hydrochloride IM injection in patients with
sion criteria will be randomized in 1:1 to
yclomine hydrochloride 20 mg IM injection
njection. Subjects will be evaluated for pain
administration of study medicine (Baseline
fter the injection. Primary and secondary
analyzed.
page 7 / 7
PDF of Trial
un, 08 Jan 2023 04:50:15 GMT)

ified Release (MR) Forms of Topiramate
bility of TPM CR vs TPM IR in Subjects with
Identifier
Protocol Number
DCGI
ClinicalTrials.gov
Jennifer Stocks-Assistant Director, Clinical Operations,
Supernus Pharmaceuticals Inc. 1550 East Gude Drive

Not Applicable
N/A
201307
India
00-301- 838-2520
00-301- 838-2504

Dr. Shiral Raina
Jubilant Clinsys Ltd C-46, Sector-62

Not Applicable
N/A
201307
India
0120 4364004
0120 4364001
shirali_raina@clinsys.com
Mr. Ashish Dasgupta Chief Operating Officer
Jubilant Clinsys Ltd C-46, Sector-62,

Not Applicable
N/A
201307
India
0120 4364001
page 1 / 5
PDF of Trial
0120 4364001
ashish_dasgupta@clinsys.com
Rockville, MD 20850 United States
Supernus Pharmaceuticals, Inc. 1550 East Gude Drive Rockville,
MD 20850 United States
Address
Brain Mind Behaviour 201, MVV Chambers, +91-9848212220

Neurosciences Opp KG Hopital, +91-891-2713686
Research Institute ,Maharanipeta, -530002 drramanand@yahoo.co
Not Applicable .in
N/A
Sir Ganga Ram 4th Floor,,Old Rajinder +91-9811046006

Hospital Department of Nagar,-110060 +91-11-45041726
Neurology, New Delhi sethiprahlad@hotmail.c
DELHI om
Sri Aurobindo Seva 1H, Garihat Road +91-9831023296

Kendra (South), ,Jodhpur 91-33-24990059
Park,-700 068, ghosh.pahari@gmail.co
Kolkata m
WEST BENGAL
St Theresa?s Hospital Erragadda, Sanath +91-9866960555

Department of Nagar, ,Near E S I +91-40-23814556
Neurology, Hospital,-500018 drvikramsharma@gmail
Hyderabad .com
ANDHRA PRADESH
St. John's Medical Sarjapur Road,-560034 +91-9341959674

College and Hospital Bangalore Fax: +91-80-25634479
KARNATAKA rroy_ajit@hotmail.com

Committee?
Review
Review
Review

Review
Date
page 2 / 5
PDF of Trial
No Date Specified
Condition
Epilepsy
Name Details
Topiramate Controlled Release
(TPM CR) Capsule 200, 250,
300, 350, or 400 mg/day QD
P.O. for 14 days
Topiramate Immediate Release
(TPM IR) Tablet 200, 250, 300,
350, or 400 mg/day BID P.O. for
14 days
Inclusion Criteria
18.00 Year(s)
65.00 Year(s)
Both
Inclusion criteria 1. Adult (18-65 years of age inclusive) male or
female subjects diagnosed with partial onset or primary generalized
seizures and receiving a stable dose of twice-daily TPM IR at either
200, 250, 300, 350, or 400mg/day as adjunctive or monotherapy for
at least four weeks prior to study start. 2. No change in
any other anti-epileptic treatment (eg, AED dosage or VNS setting)
for at least two weeks prior to screening. 3. Able to
voluntarily provide written informed consent to participate in the
study. 4. Women of child-bearing potential (WOCP) must
use an effective method of avoiding pregnancy for at least four
weeks prior to study drug administration, and must agree to continue
using such precautions through the End of Study visit. 
Exclusion Criteria
Exclusion Criteria: 1) Epilepsy/seizure exclusions a) A documented
history of generalized status epilepticus within the past two years. b)
An average seizure rate of >3 seizures/28 days. c) Current diagnosis
or recent history of non-epileptic seizures. d) An active central
nervous system (CNS) infection, demyelinating disease,
degenerative neurological disease, or any CNS disease deemed
progressive that may confound the interpretation of study results. e)
Diagnosis or an electroencephalogram consistent with a diagnosis of
seizure disorders other than partial onset or primary generalized
tonic-clonic seizures. 2) Depression/suicidality exclusions: a) Meets
criteria for current major depressive episode, according to Diagnostic
and Statistical Manual of Mental Disorders, Fourth Edition Text
Revision, for single (296.2x) or recurrent (296.3x) episodes within six
months prior to Screening (Visit 1). b) Active suicidal plan/intent or
active suicidal thoughts in the past six months. c) Suicide attempt
within the last two years or more than one lifetime suicide attempt. 3)
General health exclusions: a) History or presence of clinically
significant, chronic medical condition, especially those
contraindicating antiseizure medication, (e.g., any neurological,
gastrointestinal, endocrine, cardiovascular, pulmonary,
hematological, immunologic, renal, hepatic, or metabolic disease)
that, in the opinion of the Investigator, may affect the safety of the
subject. b) History or presence of clinically significant laboratory,
electrocardiogram (ECG), or vital sign abnormalities (e.g.,
uncontrolled hypertension) at screening that, in the opinion of the
Investigator, may affect the safety of the subject. c) Presence of
potential hepatic function impairment as shown by, but not limited to
alanine aminotransferase values >3 times upper limit of normal
page 3 / 5
PDF of Trial
(ULN), aspartate aminotransferase >3 times ULN, or total bilirubin
>1.5 times ULN. d) Presence of suspected impairment of renal
function defined by serum creatinine ≥1.5 times ULN. 4)
General exclusions: a) History of alcohol or substance abuse or
dependence within two years prior to screening. b) Females who are
pregnant or lactating. c) Use of an investigational drug or device, or
participation in an investigational study within 30 days prior to the
first dose of SM.
ome Timepoints
ome Timepoints

page 4 / 5
PDF of Trial
udy determining the relative bioavailability

ate immediate release 200, 250, 300, 350,
ents out of 72 global patients with epilepsy
n USA. The primary endpoint is
will be assessed relative to TPM IR after 14
rvals of the ratio of the dose-normalized
analyses on the ln-transformed PK
er enrollment, samples will be drawn for PK
erapy. Subjects will then be switched to the
CR) given once daily (QD) and PK samples
amples will be drawn for steady-state PK
DD) the subject is receiving at study entry
ate of enrollment in India is 15Oct'2010.
page 5 / 5
tri.nic.in
page 1 / 5
tri.nic.in
ail
50
gmail.co
42
ahoo.co
66
@gmail.
91-9810853355
akar@hotmail.com
00
ail.com
hospital.
51
@kem.ed
page 2 / 5
tri.nic.in
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 1 / 5
tri.nic.in
ail
yahoo.c
) - 079 26469846,
1) - 98244 65767
79 - 40011156
darp@hotmail.com
t Ethics
page 2 / 5
tri.nic.in
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 5
tri.nic.in
ail
@gmail.
43
hotmail.
00
oo.com
@rediffm
page 2 / 5
tri.nic.in
09219601795
thi_s@yahoo.co.in
11
oo.co.in
hoo.co.in
ail.com
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 3
tri.nic.in
ail
.com
t Ethics
page 2 / 3
tri.nic.in
page 3 / 3
tri.nic.in
page 1 / 6
tri.nic.in
ail
ahoo.co
hoo.com
fmail.co
.com
page 2 / 6
tri.nic.in
oo.com
nib17@yahoo.co.in
shetti@yahoo.com
09326980684
relalit@yahoo.com
ahoo.co
t Ethics
page 3 / 6
tri.nic.in
page 4 / 6
tri.nic.in
page 5 / 6
tri.nic.in
page 6 / 6
tri.nic.in
page 1 / 7
tri.nic.in
ail
o.com
50
50
@gmail.c
5
@aims.a
86
39
h@yaho
17
09
@gmail.
hoo.co.i
00 Extn:
12
page 2 / 7
tri.nic.in
hotmail.c
1 9831 023 296

1 33 2499 0059
ri_ghosh@vsnl.net
79
96
@gmail.c
00
36
ail.com
t Ethics
page 4 / 7
tri.nic.in
page 6 / 7
tri.nic.in
page 7 / 7
tri.nic.in
page 1 / 5
tri.nic.in
ail
@indiatim
g@gmail
@gmail.co
@gmail.co
079-26578096
shir52@gmail.com
@yahoo
9886732622
arma@yahoo.com
page 2 / 5
tri.nic.in
@hotmai
yahoo.co
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 6
tri.nic.in
ail
11-26731172;
09868398244;
09968292347
1-11-26731172
aiims@yahoo.com
;
neuro@gmail.com
a@yahoo
022 -
0566
otmail.co
020-660
00
04
nl.net
@rediffma
19
page 2 / 6
tri.nic.in
, 040-
80
mail.co
yahoo.c
022-252
0/252896
ro@yaho
079-254
25/25471
ahoo.co.i
55
com
66
@hotmail
0712-66
1/663680
mail.co
81
yahoo.c
o@hath
t Ethics
page 3 / 6
tri.nic.in
page 4 / 6
tri.nic.in
page 5 / 6
tri.nic.in
page 6 / 6
tri.nic.in
page 1 / 6
tri.nic.in
ail
.com
oo.com
Ex.
ahoo.co
@indiatim
otmail.c
page 2 / 6
tri.nic.in
03@yah
09220887386;
0251-2201531
vinod@yahoo.co.in
@gmail.c
ail.com;
hoo.com
03@yaho
a@gmail
@yahoo.c
o.com
yahoo.c
t Ethics
page 3 / 6
tri.nic.in
page 4 / 6
tri.nic.in
page 5 / 6
tri.nic.in
page 6 / 6
tri.nic.in
page 1 / 3
tri.nic.in
ail
ahoo.co
t Ethics
t Ethics
page 2 / 3
tri.nic.in
page 3 / 3
tri.nic.in
page 1 / 3
tri.nic.in
ail
@gmail.
t Ethics
page 2 / 3
tri.nic.in
page 3 / 3
tri.nic.in
page 1 / 5
tri.nic.in
ail
o.com
oo.com
o.co.in
medanta
com
i@gmail
edurolog
page 2 / 5
tri.nic.in
.ac.in
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 3
tri.nic.in
ail
ahoo.co
t Ethics
page 2 / 3
tri.nic.in
page 3 / 3
tri.nic.in
page 1 / 5
tri.nic.in
ail
otmail.co
hotmail.
gmail.co
ail.com
ediffmail
page 2 / 5
tri.nic.in
otmail.c
mail.com
@gmail.c
o.com
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 8
tri.nic.in
ail
yahoo.c
.com
ffmail.co
@hotma
page 2 / 8
tri.nic.in
diffmail.c
2002@y
t Ethics
page 4 / 8
tri.nic.in
page 6 / 8
tri.nic.in
page 7 / 8
tri.nic.in
page 1 / 5
tri.nic.in
ail
yahoo.c
o.com
@rediff
011-23234350
hndi@hotmail.com
fmail.co
page 2 / 5
tri.nic.in
@yahoo.
diffmail.c
ediffmail
ar@yaho
gmail.co
oo.co.in
23027509
korrt@yahoo.co.in
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 5
tri.nic.in
ail
@gmail.c
t Ethics
page 2 / 5
tri.nic.in
page 3 / 5
tri.nic.in
page 1 / 4
tri.nic.in
ail
@gmail.c
t Ethics
page 2 / 4
tri.nic.in
page 3 / 4
tri.nic.in
page 4 / 4
tri.nic.in
page 1 / 5
tri.nic.in
ail
@rediffma
yam.net.
naak@hotmail.com
ri_ghosh@vsnl.net
.com
t Ethics
page 2 / 5
tri.nic.in
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 6
tri.nic.in
ail
701
626
666
993
otmail.co
4465
4464
mail.com
681
gmail.co
1439
726
yahoo.c
000
479
ail.com
035
036
ail.com
t Ethics
page 2 / 6
tri.nic.in
page 3 / 6
tri.nic.in
page 4 / 6
tri.nic.in
page 6 / 6
tri.nic.in
page 1 / 4
tri.nic.in
ail
ahoo.co
ediffmail.
ffmail.co
com
t Ethics
page 2 / 4
tri.nic.in
page 3 / 4
tri.nic.in
page 4 / 4
tri.nic.in
page 1 / 5
tri.nic.in
ail
00 (Extn
07
nl.net
16
43
mail.com
88
04
com
2
47
_dr@re
page 2 / 5
tri.nic.in
1
iffmail.c
00
30
carehyd
29
39
yrgcare.
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 5
tri.nic.in
ail
559
tyam.net
383
diffmail.
107
mail.com
9718599303
91-11-23234350
hndi@hotmail.com
980
l.com
402
otmail.c
925
otmail.c
504
na@gm
page 2 / 5
tri.nic.in
t Ethics
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5
tri.nic.in
page 1 / 7
tri.nic.in
ail
e@yahoo
l.com
page 2 / 7
tri.nic.in
@rediffm
om
hoo.co.i
l@rediff
@hotmail
mail.com
t Ethics
page 3 / 7
tri.nic.in
page 5 / 7
tri.nic.in
page 6 / 7
tri.nic.in
page 7 / 7
tri.nic.in
page 1 / 5
tri.nic.in
ail
20
86
ahoo.co
06
26
hotmail.c
96
9
gmail.co
55
56
a@gmail
74
634479
ail.com
t Ethics
page 2 / 5
tri.nic.in
page 3 / 5
tri.nic.in
page 4 / 5
tri.nic.in
page 5 / 5

Example 001 51 Merged

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Example 001 51 Merged

Uploaded by

Copyright:

Available Formats

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:47:04

CTRI Number CTRI/2010/091/000096 [Registered on: 05/03/2010] -

Secondary IDs if Any Secondary ID

Details of Secondary Name

Sites of Study Name of Principal Name of Site

Col T V S P Murthy Command Hospital

Dr. P. N. Kakar Fortis Hospital

Dr. B. M. Subnis Padmashree Dr. D. Y.

Dr Anil Varshney R G Stone Urology &

Dr. Prerana Shroff Seth GS M

Details of Ethics Name of Committee Approval Status

Institutional Ethics Approved

Institutuional Ethics Approved

Regulatory Clearance Status

Health Condition / Health Type

Method of Generating Computer generated randomization

Secondary Outcome Outcome

Target Sample Size Total Sample Size=250

Phase of Trial Phase 3

Recruitment Status of Not Applicable

ml formulation given as IV infusion in the management of post operative pain.

CTRI Number CTRI/2010/091/000163 [Registered on: 30/04/2010] -

Secondary IDs if Any Secondary ID

Details of Secondary Name

Sites of Study Name of Principal Name of Site

Dr. Kandarp Parikh Sterling Hospital Road,

Details of Ethics Name of Committee Approval Status

Sterling Hospitals Approved

Method of Generating Computer generated randomization

Treatment Response: Reduction of greater than

Change from Baseline in mean worst daily pain

Target Sample Size Total Sample Size=360

Phase of Trial Phase 3

CTRI Number CTRI/2010/091/000174 [Registered on: 03/03/2010] -

Secondary IDs if Any Secondary ID

Details of Secondary Name

Dr. Kumara Swamy Basauangudi ENT Care

Dr. Kilash. N Dr. B.R. Ambedkar

Dr. Gurdeep singh Dr. Gurdeep singh,

Dr. S.P yadav Dr. S.P yadav,

Dr. Shriram Kulkarni Kharghar Diabetes and

Dr Sudhir Rathi LLRM Medical College

Dr. Sandeep Kumar M.V. Hospital &

Dr. Ashish Makkar Makkar Medical Center

Dr. Sapna Verma Ramakrishna Medical

Dr Lalit Kaushal Saket Hospital

Dr Mahip Saluja Subarti Medical

Details of Ethics Name of Committee Approval Status

Institutional Ethics Approved

Institutional Ethics Approved

North Zone Approved

Method of Generating Computer generated randomization

Secondary Outcome Outcome

Target Sample Size Total Sample Size=654

Phase of Trial Phase 3

Date of First 24/02/2010

Recruitment Status of Completed

Secondary IDs if Any Secondary ID

Details of Secondary Name

Details of Ethics Name of Committee Approval Status

Regulatory Clearance Status

Method of Generating Not Applicable

Blinding/Masking Not Applicable