|
Sr. No.
|
IEC assigned No.
|
Title
|
Name of PI
|
Location
|
-
|
IEC/1/2000
|
A phase II
study of Gemitabine, Paclitaxel and cisplatin in chemotherapy naïve FIGO
stage III B and IV ovarian cancer
|
Dr. Purvish
M. Parikh
|
Tata
Memorial Hospital, Mumbai
|
-
|
IEC/2/2000
|
An open non
comparative study of efficacy and safety of ketoprofen IV in the treatment of
cancer pain
|
Dr. Purvish
M. Parikh
Dr.
L.J.D'Souza
|
Tata
Memorial Hospital, Mumbai
|
-
|
IEC/4/2001
|
A study of
gynaecological morbidity and common mental disorders in Goa
|
Dr. Vikram
Patel
|
Goa
|
-
|
IEC/5/2001
|
A
randomized, double-blind, placebo controlled trial of the weekly Azithromycin
on the Incidence of coronary Artery Disease in subjects with evidence of
exposure to C.pneumoniae
|
Dr. Sholab
Padaria
|
Jaslok
Hospital, Mumbai
|
-
|
IEC/6/2001
|
To assess
the dose proportionality of bioavailability by comparing the pharmacokinectic
parameters of bulaquine after oral dose of 12.5 mg, 25mg, 37.5 mg to healthy
adult, male human subjects under fasting conditions
|
Dr. Satish
Chandra Bhatia
|
Wellspring
Hospital, Mumbai
|
-
|
IEC/7/2001
|
A single
dose randomized two sequence two period cross over bioequivalence study of
Warfarin comparing Norton and Gold shield (marevan) 0.5mg tablets in healthy
adults under fasting conditions
|
Dr. Satish
Chandra Bhatia
|
Wellspring
Hospital, Mumbai
|
-
|
IEC/8/2001
|
A
multiple-dose, two-treatment, two period, pharmacokinetic study of bulaquine
in the absence and presence of chloroquine in healthy adult male subjects
under fed conditionsd
|
Dr. Satish
Chandra Bhatia
|
Wellspring
Hospital, Mumbai
|
-
|
IEC/9/2001
|
A pilot (
feasibility) study for a post natal depression study in Goa
|
Dr. Nandita
D'Souza
|
Goa
|
-
|
IEC/10/2001
|
The early
predictors of a healthy adolescence: a community cohort study in Goa, India
|
Dr. Vikram
Patel
|
Goa
|
-
|
IEC/11/2001
|
A
multicentric clinical trial of low molecular weight Heparin [Reviparin] and
Glucose- Insulin and Potassium (GIK) in patients with acute myocardial
infarction
|
Dr. Prem Pai
Dr. Denis
Xavier
|
St.Johns
Medical College, Bangalore
St.Johns
Medical College, Bangalore
|
-
|
IEC/12/2001
|
Prazosin
GITS versus Terazosin in patients with Benign Prostatic Hyperplasia : A 10-
week, open, randomized, comparative, Parallel-Group, Multicenter study
|
Dr. Sadhna
Joglekar
|
Pfizer,
Mumbai
|
-
|
IEC/13/2001
|
Comparative
efficacy and tolerability of sustained release (OD) tablets and Conventional
release tablets of ciprofloxacin in complicated urinary tract infection: A
double-blind study
|
Dr.
S.K.Mishra
|
Ranbaxy
|
-
|
IEC/14/2001
|
PEARL (Post
menopausal Evaluation And Risk Reduction with Losofoxifene)
Protocol
No. A2181002
|
Dr.
Aakash Ganju
Dr.
Ranu Patni
|
PRAYAAS
Jaipur
|
-
|
IEC/16/2001
|
Efficacy
and safety of Linezolid in patients with community-Acquired Pneumonia
|
Dr. Vikas
Kumar Sinha
|
Dr.
Reddy's Laboratories Ltd, Hydrebad
|
-
|
IEC/17/2001
|
A four
week, open label, Phase 3 trial of Tab Montelukast 10mg in patients with mild
to moderate asthma .
|
Dr. Amit
Taneja
|
Corp
Med Services
|
-
|
IEC/1/2002
|
Mobilizing
youth for action against Tobbaco in India
|
Prof. K.Srinath
Reddy
|
HRIDAY
New Delhi
|
-
|
IEC/02/02
|
Evaluation
of the safety and efficacy of Quinapril in the treatment of Hypertension
|
Dr. Raman
V.Shetty
|
Cipla Ltd,
Mumbai
|
-
|
IEC/03/02
|
Evaluation
of the safety and efficacy of Cilostazol in patients of intermittent claudication
|
Dr. Raman
V.Shetty
|
Cipla Ltd,
Mumbai
|
-
|
IEC/04/02
|
Protocol
for a community – based , randomized, controlled trial of a counseling
intervention for post natal depression in Goa
|
Dr. Marcus
Hughes
|
Sangath
Centre for child development and Family Guidance
|
-
|
IEC/05/02
|
Glimepiride
versus Metformin as monotherapy in pediatric subjects with type 2 diabetes
Mellitus: A single blind comparison study
|
Dr. Aspi
J.Irani
|
--
|
-
|
IEC/02/2003
|
A
multicentre, randomized, double-blind, double dummy comparative trial of Azithromycin
SR versus Levofloxacin for the treatment of acute exacerbation of chronic
bronchitis.
|
Dr. Pradeep
Mehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/03/2003
|
A
multicentre, randomized, double-blind, double dummy comparative trial of
Azithromycin SR versus Levofloxacin for the treatment of mild to moderate
community – acquired pneumonia in adults.
|
Dr. Ashok
Bajpai
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/04/03
|
A Phase III, twelve week, double blind and placebo controlled study to evaluate the safety and efficacy
of two doses of
CP-448,187
(1.5mg and 3.0 mg) in subjects with obsessive compulsive disorder
|
Dr. Suman
Khanna
|
National
Institute of Mental and Neurosciences, Bangalore
|
-
|
IEC/05/03
|
A
randomized, double-blind, double-dummy, multicentric, parallel-group,
comparative clinical trial of S-Atenolol 50mg in the treatment of mild to
moderate hypertension.
|
Dr. Hemant
P.Thacker
|
Mumbai
|
-
|
IEC/06/03
|
An
open-label, randomized, multicente, phase III, parallel group study to
compare the efficacy and safety of rosuvastatin and atorvastatinin Indian
subjects with Type IIa and IIb hy
|
Dr. Georgy
Nainan
Dr.
D.K.Phahari
|
PVS Memorial
Hospital, Kerala
Rabindranath
Tagore International center of cardiac science Kolkatta
|
-
|
IEC/07/03
|
A phase II/III, randomized, comparative trialof Azithromycin plus chloroquine for the treatment of
uncomplicated plasmodium falciparum malaria in India
|
Dr. P.C.
Bhattacharya
|
Kolkatta
|
-
|
IEC/09/03
|
An open
multicentric, post-marketing surveillance study of GlaxoSmithkline
biologicals combined hepatitis A- hepatitis B vaccine (TWINRIX) injected as a
three dose primary vaccination course according to the prescribing
information in healthy children and adults
|
Mr.Sachin
Mangalvednekar
|
GlaxoSmithkline
|
-
|
IEC/10/03
|
An open,
non-comparative, multicentric, 12 weeks study to assess the penetration of
topical 0.3% gatifloxacin into the human aqueous humour
|
Dr. M.R.Jain
|
MRJ
Institute and Jain and Jain Eye Hospital, Jaipur
|
-
|
IEC/11/03
|
An open,
non-comparative, multicentric, 12 weeks study to assess efficacy and safety
of 5% Imiquimod cream in the treatment of adults and adolescent Indian
patients with genital warts
|
Ms.Purnima
Mahadik
|
Cipla Ltd
Mumbai
|
-
|
IEC/13/03
|
An
observational study on achieved Formalin fixed paraffin embedded (FFPE)
Tissue to determine Molecular Markers for establishing disease outcomes,
response to therapy and markers of disease progression in Breast cancer
|
Mr.Sudhir
Borgonha
|
Triesta
sciences
Bangalore
|
-
|
IEC/14/03
|
The POISE
study: A large, simple, trial of metoprolol versus placebo in patients
undergoing non cardiac surgery at moderate and high risk of a perioperative
cardiac event
|
Dr. Denis
Xavier
|
St.Johns
Medical College, Bangalore
|
-
|
IEC/15/03
|
VITATOPS
STUDY, VITAMINS TO PREVENT STROKE study: A multicentre, randomized,
double-blind, placebo-controlled clinical trial examining the efficacy and
safety of multi-vitamin therapy in secondary stroke prevention
|
Dr. Denis
Xavier
|
St.Johns
Medical College, Bangalore
|
-
|
IEC/16/03
|
A
randomized, open , parallel, comparative study of the efficacy and
tolerability of a special formulation of the combination of a Glipizide and
metformin-timed release (TR)with the conventional combination of Glipizide
and metformin Immediate release (IR) in type 2 diabetes mellitus
|
Dr. Gulrez
Tyebkhan
|
Sun
pharmaceutical Ltd, Mumbai
|
-
|
IEC/17/03
|
A
prospective observational longitudinal study to evaluate molecular markers
for disease staging, disease progression and treatment response in Breast
carcinoma
|
Dr. Govind
Babu
|
Triesta
sciences
Bangalore
|
-
|
IEC/18/03
|
A phase II/III Randomised Comaparative Trail of Azithomycin Plus Chloroquine versus sulfadoxine –
Pyrirnethamine Plus Chloroquine for the treatment of uncomplicated plasmodium
falciparum malaria in India
|
Dr. Ashok
Sethia
|
Geeta Bhavan
Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/1/2004
|
Clinical
Uility of Amlodipine/ Atorvastatin to improve concomitatnt cardiovascular
risk factors of hypertension and dyslipidemia
|
Dr. Shoaib F
Padaria
Dr. Hemant P
Thacker
Dr. JPS
Sawhney
|
Dr. Padaria's
Polyclinic, Mumbai
Mumbai
Sawhney
heart center, New Delhi
|
-
|
IEC/2/2004
|
To
establish the prevalence of coronary heart diseases (CHD) related risk
factors
|
Voluntary
Association of Goa (VHAG)
|
Goa
|
-
|
IEC/3/2004
|
To
establish the prevalence of alcohol misuse and its risk factors
|
Voluntary
Association of Goa (VHAG)
|
Goa
|
-
|
IEC/5/2004
|
An
international randomized, double-blind study evaluating the efficacy and
safety of fondaparinux versus enoxaparin in the acute treatment of instable
angina/ non-st-segment evaluation MI acute coronary syndromes
|
Ms.Kalpana
Gopalkrishnan
|
Quintiles,
Mumbai
|
-
|
IEC/06/2004
|
Healing of
Patients suffering from gastroesophageal reflux esophagitis Grade A-D
according to Los Angeles classification after treatment with pantoprazole –
sodium sesquihydrate 40 mg O.D over 4 or 8 weeks
|
Dr.
Prashanth Bhandarkar
Dr.
Wadhawa
|
Nagpur
Mysore
|
-
|
IEC/07/04
|
Open,
randomized, multicentre study to evaluate efficacy anf safety of oral
Valganciclovir versus IV Ganciclovir for the treatment of CMV disease in solid
organ transplant recepient
|
Dr. C.M.
Thiagarajan
|
Tamilnadu
|
-
|
IEC/08/04
|
An
international randomized study evaluating the efficacy and safety of fondaparinux
sodium versus control therapy and glucose- insulin-potassium infusion versus
control in a broad range of patients with ST segment elevation acute
myocardial infarction clinical study
|
Dr. Denis
Xavier
|
--
|
-
|
IEC/09/04
|
A
randomized comparative, parallel, double blind, multicenter trial of ditropan
XL and oxybutynin TR in patients with symptoms of overactive urinary bladder
|
Dr.
Vivek Birla
Dr.
Ketan M Desai
|
Sun Pharma
|
-
|
IEC/10/04
|
An
observational study to determine the side effect profile of promasin for
hormone dependent breast cancer in post menopausal women
|
Sterling
synergy
|
--
|
-
|
IEC/11/04
|
An
observational study to compile the tolerability profile of xalacom, intended
for treatment of open angle glaucoma and ocular hypertension when used in
clinical practice
|
Siro India
|
--
|
-
|
IEC/12/04
|
A 24 week,
double-blind, parallel group, placebo and active controlled study to
investigate the efficacy and safety of daily oral relumilast taken with low
dose inhaled corticosteroids in patients with chronic asthma
|
Dr. Pradeep
Mehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/13/04
|
An open
label, non comparative, multicentric study to evaluate the efficacy and
tolerability of lyrica (pregabalin)in neuropathic pain
|
Dr. A.V.
Srinivasan
|
--
|
-
|
IEC/14/04
|
An open, non comparative,
multicentric study to assess efficacy and safety of fixed dose combination of
timolol 0.5 % and dorzolamide 2% ophthalmic solution in patients with open
anglr glaucoma or ocular hypertension
|
Ms.Rashmi
Patkar
|
--
|
-
|
IEC/15/04
|
The original trial (outcome
reduction with initial glargine intervention) Hoe901/14032 insulin glargine
|
Dr. Parag
Shah
|
Ahemdabad
|
-
|
IEC/16/04
|
An open labelled, randomised,
comparative, prospective, multicentric study to evaluate the efficacy and
safety of XEED- 4 FDC containing rifampicin, isoniazid , pyrazinamide and
ethambutol and XEED- 2 FDC containing rifampicin and isoniazid in comparison
with AKurit 4 / AKurit 2 (Fixed dose combinations of rifampicin, isoniazid,
pyrazinamide and ethambutol /isoniazid and rifampicin respectively )in
treatment of patients suffering from pulmonary tuberculosis
|
Dr. Ashish
Gulati
|
--
|
-
|
IEC/17/04
|
"KIGS,
Advanced Patient Outcome: Survey number: SN 87-052-38 (GENOTROPIN)"
|
Dr. Anju
Virmani
|
--
|
-
|
IEC/18/04
|
An
open label, randomized, parallel group, multicenter study to evaluate the
efficacy and safety of enoxaparin versus unfractionated heparin in the
prevention of venous thromboembolism in patients following acute ischemic
stroke
|
Dr.
Anup Karnik
|
--
|
-
|
IEC/19/04
|
An
open, non-comparative, prospective, multicentre study to evaluate the safety,
tolerability and efficacy of adefovir dipivoxil in treatment of chronic HBV
infection
|
Dr.
Deepak Amapurkar
Dr.
Abha Nagral
Dr.
Dharmesh Kapoor
|
Hydrebad
|
-
|
IEC/20/04
|
Scientigraphic
study on inhalation aerosol formulation
|
Dr.V.K.Mathur
Dr.
Amruta Bajaj
|
--
|
-
|
IEC/21/04
|
Live
care in hepatitis caused by hepadana group of viruses
|
Dr.
G Venkatram
|
--
|
-
|
IEC/22/04
|
A
12 week, multicentre, randomized, double blind, placebo controlled trial of
the safety and efficacy and intravenous remodulin in patients in India with
pulmonary arterial hypertension CPAH
|
Dr.
M.S.Raj
Dr.
S.
Shammugasundaran
|
--
|
-
|
IEC/01/05
|
"In
vitro screening to identify and evaluate test substances for their
anti-inflammatory potential"
|
Dr.
Himanshu Parikh
Dr.
Kalpana Joshi
|
Mumbai
Mumbai
|
-
|
IEC/02/05
|
A
phase III, randomized stratified parallel group, multicenter, comparative
study of ZD1839 (IRESSA) 250mg and 500mg versus methotretate for previously
treated patients with squamous cell carcinoma of the head and neck
|
Dr.
K.J.Bhowmik
|
New Delhi
|
-
|
IEC/03/05
(A)
|
Bioequivalence
study comparing Duovir N tablets (containing lamivudine 150mg, zidovudine 300
mg) and nevirapine 200mg of cipla ltd India with combvir (containing
lamivudine 150mg and zidovudine 300mg) of Glaxosmithkline USA, viramune
tablet containing nevira 200mg of Boehringer Ingelheim USA in healthy human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/04/05
|
Bioequivalence
study comparing loperamide 2mg tablet (of cipla ltd, India) with Imodium
tablet (loperamide 2 mg of janssen-Cilag, Denmark in healthy human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/05/05
|
Bioequivalence
study comparing olanzapine 10mg tablet of cipla ltd, India with zypreta
tablet (containing olanzapine 10mg ) of Eli lilly and company ltd, UK in
healthy male human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/06/05
|
Bioequivalence
study comparing Duovir N tablets (containing lamivudine 150mg, zidovudine 300
mg) and nevirapine 200mg of cipla ltd India with combvir (containing
lamivudine 150mg and zidovudine 300mg) of Glaxosmithkline USA on healthy
human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/07/05
|
Bioequivalence
study comparing levocetirizine dihydrchloride 5mg tablet of cipla ltd, India
with xyzar tablet (containing levocetirizine dihydrchloride 5mg) of UCB
pharma, UK in healthy male human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/08/05
|
Bioequivalence
study comparing granisetron 2mg tablet of cipla ltd India with kytril tablet
(containg granisetron 2mg) of Roche, UK in healthy human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/09/05
|
Bioequivalence
study comparing pioglitazone 45mg tablet of cipla ltd, India with actos
tablet (containing pioglitazone 45mg ) of takeda, UK in healthy human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/10/05
|
Comparative
bioavailability study of triomune-40 tablet (containing lamivudine 150mg,
stavudine 40mg and mevirapine 200mg ) of cipla ltd, India with Epivit tablet(containing
lamivudine 150mg) of Glaxosmithkline, USA , Zerit Capsule (containing
stavudine 40mg ) of Bristol Myers Squibb, USA and Viramune tablet (Containing
mevirapine 200mg ) of Boehringer Ingelheim USA in healthy human subjects
|
Dr.
Lalit D Anande
|
--
|
-
|
IEC/05/11
|
A
randomized, open label multicenter, parallel group study evalauating the
efficacy and safety of 135 mcg and
90
mcg of PEGSYS given as monotherapy to patients with chronic hepatitis C and
renal disease undergoing hemodialysis
|
Dr.
Samir Shah
Dr.Bharat
Shah
Dr.
Chetan Bhatt
Dr.
Arun Halankar
|
Mumbai
|
-
|
IEC/05/12
|
Evaluation
of safety, tolerability and imunogenecity of vaccination with Varivax in
healthy Indian children
|
Dr.
Jagadish Chinappa
Dr.
Sanjay Bafna
|
Bangalore
Pune
|
-
|
IEC/05/13
|
In
practice usage and performance study of curosurf (post marketing surveillance
study)
|
Dr.
Amit Ray
Dr.
K.R.Shankar
Dr.
Dinesh Chirla
Dr.
N.Kabra
Dr.PMC
Nair
Dr.
Hiren Doshi
Dr.
Umesh Udidya
|
--
|
-
|
IEC/05/14
|
Prospective,
single arm, investigator oriented screening study to evaluate the incidence
of CMV infection in moderate- to-severe cases of ulcerative colitis and
crohn's disease
|
Dr.
Chetan B.Bhatt
|
--
|
-
|
IEC/05/19
|
A
study of safety, tolerability and immunogenecity of pneumovax 23 in healthy
adults in India – Registration study product V10
|
Dr.
Hemant Gupta
Dr.
Gautam Ramkanthan
Dr.
Jagadish Gotur
|
---
|
-
|
IEC/05/20
|
Therapeutic
confirmatory study to evaluate the safety and efficacy of Atropine
(recombinant Human erythropoietin) in CRF (chronic renal failure) patients.
single blinded, randomized, active drug comparator, parallel design,
multicentre, multinational study
|
Dr.
Georgy Nainan
|
Cochin
|
-
|
IEC/05/21
|
A
placebo controlled, double-blind, parallel arm trial to assess the efficacy
of dronedarone 400mg BID for the prevention of cardiovascular hospilitation
or death from any cause in patients with atrial fibrillation/ atrial flutter
(AF/AFL)
|
Dr.
Amit Vora
Dr.T.S.K
Dr.
P.Vadagenali
Dr.
C.Naramsimhan
Dr.
U.Pandurang
Dr.
A.Khan
Dr.
R Verma
Dr.
R Yadave
Dr.
A Ravikishore
Dr.
Punit Verma
|
Cardiac
centre,
Mumbai
|
-
|
IEC/05/22
|
A
multicentre, double-blind, randomized, placebo controlled, parallel group,
flexible dose titration, add on study of mecamylamine 5.0 to 10 mg in the
treatment of major depressive disorder with subjects who are partial
responders or non- responders to citalopram therapy
|
Dr.
Vihang N Vahia
Dr.
Yusuf Abdullah Matcheswalla
Viral
C Shah
|
Spectrum
Global Ltd
|
-
|
IEC/05/24
|
A
randomized, comparative, placebo controlled double blind study to evaluate
the efficacy and safety of LHR- 2449mF a herbal formulation in male patients
suffering from infertility
|
Dr.
K.Selvaraj
|
Lupin Ltd,
Chennai
|
-
|
IEC/05/28
|
A
prospective, multicentric, randomized comparative parallel group two-arm
assessor- blind proof of concept study to evaluate the safety and efficacy
of two preparations of recombinant follicle stimulating hormone in induction
of ovulation in women with chronic anovulation who have failed therapy with
atleast three cycles of clomiphene citrate
|
Dr.
M.Parihar
Dr.
S.Desai
Dr.
M.Patnaik
Dr.
K.Padte
Dr.
J.Shah
Dr.
J.Mahotra
Dr.
S.Padganokar
Dr.
M.Bankar
Dr.
P.C. Mohapatra
|
Orissa
Panaji
Mumbai
|
-
|
IEC/05/31
|
A
randomized, double-blind, double dummy, parallel group, multicentre study to
compare the efficacy and tolerability of HFA-propelled combination Fluticasone
propionate 125mcg and salmeterol xinafoate 25mcg PMDI with separate
HFA-propelled Fluticasone propionate 125mcg PMDI and CFC-propelled salmeterol
Xinafoate 25mcg PMDI in patients with mild to moderate asthma
|
Dr.
Jaychandra
Dr.Thomas
Dr.Venugopal
Dr.
Padmanabhan
Dr.
V.G.
Prabhudesai
Dr.
Deepali Kamdar
Dr.
Premanand
Dr.
Subha K.
Dr.K.hari
Dr.
H.B.
Chandrashekar
|
--
|
-
|
IEC/05/32
|
An
open, non-comparative, prospective multicentre study to evaluate the efficacy
and safety of 0.1% olopatadine ophthalmic solution in patients with allergic
conjunctivitis
|
Dr.
M.A.Parekh
|
Lotus eye
hospital, Mumbai
|
-
|
IEC/06/01
|
Efficacy
and safety of SII recombinant Human erythropoietin , rHuepo, SII poietin for
treatment of Anemia in chronic renal failure. Patients on maintenance
Hemodialysis when compared to E poetin alfa (EPREX)
|
Dr.
V.Billa
|
Serum
Institute India
|
-
|
IEC/06/02
|
A
multicenter, open label, study evaluating the efficacy and safety of
epinastine hydrochloride 0.05% ophthalmic solution used twice daily for 3
weeks in adult patients with seasonal allergic conjunctivitis
|
Dr.
Vinay Agarwal
Dr.
J.S.Shetty
|
Allergan
India ltd
|
-
|
IEC/06/03
|
LJP
394-90-14: A randomized, double-blind, placebo-controlled, four arm, parallel
group, multinational safety and efficacy trial of 100mg, 300mg and 900mg of
sodium in systemic lupus erythematosus (SLE) patients with a history of renal
disease
|
Dr.
Georgy Ninan
Dr.
D.K.Pahari
|
Kaloor
Kolkatta
|
-
|
IEC/06/04
|
A
6 week, multicenter, open label, non-comparative study of the efficacy and
safety of Bimatoprost 0.03%/Timolol 0.5% fixed combination ophthalmic
solution patients with glaucoma or ocular hypertension with an elevated
intraocular pressure with or without other antiglaucoma therapy
|
Dr.
Jyothi S Shetty
|
--
|
-
|
IEC/06/05
|
A
multicentre, afinamide panel, open label, non comparative study to
investigate the safety, tolerability and pharmacokinetics of caspofungin
acetate in neonates and infants less than 3 months of age
|
Dr.
S.R.Janaki
|
Clinigene
International Pvt ltd., Bangalore
|
-
|
IEC/06/06
|
Human
subjects in a research study entitled "The Epidemiology and Etiology of
obesity among youth in Urban India (Ancillary study to project MYTRI)
|
Ms
Monika Arora
|
Hriday, New
Delhi
|
-
|
IEC/06/07
|
A
6 weeks, double-blind, placebo-controlled study to determine the efficacy and
safety of a combination inhaler of ciclesonide/ formoterol and ciclesonide alone in
subjects with persistant asthma
|
Dr.
Murali Mohan
Dr.
K.S.Satish
|
--
|
-
|
IEC/06/08
|
A
phase III, double-blind, placebo-controlled study to determine the efficacy
and safety of a low (50-100mg/day) and high (150-200mg/day) dose range of
safinamide as add on therapy in patients with idiopathic Parkinson's disease
with motor fluctuations treated with a stable dose of levodopa and who may be
receiving concomitant treatment with stable doses of dopamine agonist and /or
anticholinergic"
|
Dr.
A.Srinivasan
Dr.
Neeta A Shah
Dr.
S.Kothari
Dr. Suresh
Kumar
Dr. Chandrashekhar
Meshram
|
Chennai
|
-
|
IEC/06/08-A
|
Protocol
no NW-1015/018/III/2006 "A phase-III, double-blind, placebo-controlled, 12
month extension study to investigate the long-term efficacy and safety of a
low (50-100 mg/day) and high (150-200mg/day) dose range of Safinamide, as
add-on therapy in patients with Idiopathic Parkinson's disease with motor
fluctuations, treated with a stable dose of levodopa and who may be receiving
concomitant treatment with stable doses of dopamine agonist and/or an
anticholinergic"
|
Dr. Suresh
Kumar
Dr. Chandrashekhar
Meshram
Dr. Neeta
Mehta
|
Mumbai
|
-
|
IEC/06/09
|
Tobbaco
use among young persons belonging to low socio-economic groups in urban
India; dimensions, determinants and dynamics of behaviour change through a
community based intervention
|
Ms.Monika
Arora
Dr.
R.Tandon
|
Hriday
, New Delhi
|
-
|
IEC/06/10
|
To
study the oral health status of patients receiving psychiatric care (as out
patients as well as in patients) and its relation to their psychiatric
illness and lifestyle factors ( influencing the same ) at the S.V.D Savarkar
Municipal General Hospital, Mulund
|
Dr.
Abhijeet S Kulkarni
Dr.
S.Kumavat
Dr.
Geeta Joshi
|
Mumbai
|
-
|
IEC/06/11
|
Study
No. A 0081046 "A randomized comparative double-blind parallel-group
multicenter, monotherapy study of Pregabalin ( Lyrica ) & Lamotrigine
(Lamictal) in patients with newly diagnosed partial seizures.
|
Dr.
Pradeep Mehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/06/12
|
Treatment
response in patients with symptoms due to gastroesophageal reflux disease
either with or without esophagitis treated with pantaprazole sodium 40mg OD 8
weeks
|
Dr.
P.Wadhwa
|
Mysore
|
-
|
IEC/06/13
|
A
cross-sectional survey of burden of illness (BOI) in Indian patients with
neuropathic pain
|
Dr.
Rajiv Anand
Dr.
Pradeep G Talwakar
Dr.
A.K.Banarjee
Dr.
A.V.Srinivasan
Dr.
R.Shridharan
Dr.
Vinayaka Sinha
|
Mumbai
Kolkatta
|
-
|
IEC/06/14
|
A
13 week randomized, multicenter, double-blind and placebo controlled,
parallel group study to evaluate the efficacy, safety and tolerability of
Pregabalin lyrica (150-600mg/day ) using a flexible dosing schedule in the
treatment of subjects with central post-stroke pain (CPSP)
|
Dr.
A.V.Srinivasan
|
Chennai
|
-
|
IEC/06/15
|
Efficacy
and safety of CFC-free formulation of budesonide compared with the reference
CFC formulation in patients with asthma: a randomized multicenter,
double-blind trial in parallel groups of patients with persistent moderate
asthma.
|
Dr.
Raj Bhagat
Dr.
Pradyut Waghray
Dr.
S.Z.Jaffery
Dr.
V.Singh
|
Ahemdabad
Hydrebad
Indore
Jaipur
|
-
|
IEC/06/16
|
Evaluation
of safety tolerability and immunogenecity of Quadrivalent HPV Vaccine in
healthy female 9 to 15 years of age in India
|
Dr.
M.R. Lokeshwar
Dr.
Kamini Rao
|
Mumbai
Bangalore
|
-
|
IEC/06/17
|
Study
A0081101 – A 12 week, open label, safety trial of pregabalin in patients with
fibromyalgia
|
Dr.
PradeepMehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/06/17-A
|
Study
A0081100-A 14 week randomized double-blind, placebo controlled trial of
pregabalin twice daily in patients with fibromyalgia
|
Dr.
PradeepMehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/06/18
|
A
phase II, 4 week randomised, double-blind, placebo-controlled, dose ranging,
proof of concept study to evaluate, safety, tolerabilitry and effect on
glycemic control of GRCA200, a new oral DPP-IV inhibitor, in patients with
type II diabetes mellitus, folowed by an 8-week, open-label extension
|
Dr.
V.Rajendran
|
Coimbatore
|
-
|
IEC/06/21
|
A
phase II, randomised , open-label, controlled clinical trial to evaluate
safety and efficacy of WCK 771 in comparison with Vancomycin or cefazolin in
the treatment of complicated skin and soft tissue infections caused by gram
positive bacteria
|
Dr.
P. Ramakrishna
Dr.
S.Vyas
Dr.
S.Iyer
Dr.
J.Stephen S
Dr.
A.K.Dallal
Dr.
P.K.Dutta
Dr.
M.Gore
Dr.
Dilip Amonkar
Dr.
P.Rama Suba Reddy
|
Hydrebad
Ahemdabad
Kochi
Bangalore
Chandigarh
Kolkatta
Mumbai
Goa
Tirupati
|
-
|
IEC/06/22
|
A
phase II/III randomised, controlled, double-masked, multicentre, comparative,
dose-finding trial in parallel groups to compare the safety and efficacy of
intravitreous injections of 0.3, 0.03 or 0.003 mg pegaptanib sodium (Macugen)
given as often as every 6 weeks for 3 years to sham injection in subjects
with diabetic macular edema (DME) involving the centre of the macula
|
Dr.
Manish Nagpal
|
Ahemdabad
|
-
|
IEC/06/23
|
Nutrition
intervention trial in human subjects entitled effect of diets rich in omega
3 fatty acids and plan sterols on the composite risk profile of dyslipidemic
adults
|
Dr.
K.Srinath Reddy
|
--
|
-
|
IEC/06/24
|
Protocol
No.CSPA 100A 2301, a 54 week, open label, multicenter study to assess the
long term safety and tolerability of the combination of aliskiren 300 mg/
amlodipine 10mg/ in patients with essential hypertension
|
Dr.
PradeepMehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/06/25
|
Redism
study (REveal for Diagnosis of Infrequent Symptoms in India)
|
Dr.
Amit Vora
Dr.
Yash Lokhandwala
|
Kikabai
Hospital
|
-
|
IEC/06/26
|
Protocol
RWJ 333369-EPY-3001/3064 (19th July 2006) a randomized double-blind placebo
controlled parallel group multicenter study to evaluate the efficacy safety
and tolerability of RWJ-333369 as adjunctive therapy in subject with partial
onset seizures followed by an open-label extension study
|
Dr.
Satish Jain
|
--
|
-
|
IEC/06/28
|
A phase III, multicenter, pilot randomized ascending dose, double-blind, placebo controlled, dose
titration study to determine the safety, Maximum tolerated dose and
preliminary evidence of efficacy of ralfinamide in the range of 80-320 mg
/day in patients with neuropathic pain
|
Dr.
A.V. Srinivasan
Dr.
Chandrashekhar Meshram
Dr.
Sudhir Kothari
|
--
|
-
|
IEC/06/29
|
The
prevalence of alcohol misuse and its risk factor among general practice
attendees
|
Prof
Michael King
|
Goa
|
-
|
IEC/06/30
|
The
prevalence of coronary heart diseases and its risk factor among general
practice attendees
|
Prof
Michael King
|
Goa
|
-
|
IEC/06/31
|
To improve
the health and survival of mothers and new born infants in under priviledged
communities in Mumbai
|
Dr.
A.R.Fernandez
Dr.
Sarah Barnett
Dr.
Neena Shah More
|
SNEHA,
Mumbai
|
-
|
IEC /06/32
|
A
randomized, double-blind, multicenter, placebo controlled clinical trial of
heptovit to study the efficacy and safety in the treatment of infective
hepatitis
|
Dr.
Abha Nagral
Dr.
Smita Nalwade
|
Kasturbha
Hospital
|
-
|
IEC/06/33
|
To evaluate
the efficacy of oral herbal preparations in the reduction of acne Grade I and
II and pigmentation in a randomized, double blind parallel treatment
|
Dr.
H.R.Jerajani
Dr.
Tejas Deshmukh
|
--
|
-
|
IEC/06/34
|
A
multicenter, double blind, randomized, controlled, parallel comparison of
efficacy and safety of fixed doses of two formulations of botulinum toxin
type A in the treatment of moderate to severe cervical dystonia (botox 200
units and disport 500 units )
|
Dr.
A.V.Srinivasan
Dr.
Charulatha Sankhla
|
Reliance
clinical research service
|
-
|
IEC/06/36
|
A
prospective open-label, comparative study to evaluate the efficacy and safety
of Human Tetanus Immunoglobulin (HTIG) monoclonal and polyclonal, in
confirmed tetanus cases
|
Dr.
S.N.Sinha
Dr.
M.N.Siddiqui
Dr.
Aravind Singh
Dr.
Kamlesh Tewari
Dr.
Umesh Jha
|
Bihar
|
-
|
IEC/07/01
|
Randomized
multinational, double-blind study comparing a high loading dose regimen of
clopidogrel versus standard dose in patients with unstable angina or non-St
segment elevation myocardial infarction managed with an early invasive
strategy
|
Dr. V.Dayasagar
Rao
|
--
|
-
|
IEC/07/02
|
Prospective
randomized phase IV open label comparative study of dalteparin vs
unfractionated heparin for the prevention of venous thromboembolism in
hospitalized acutely ill medical patients.
|
Dr.
Pradeep Mehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/07/03
|
A
multicenter, double-blind randomized study to compare the safety and efficacy
of prulifoxacin versus placebo in the treatment of acute gastroenteritis in
adult travelers; phase 3, protocol no. OPT-099-002
|
Dr. Santanu
chatterjee
|
Kolkatta
|
-
|
IEC/07/04
|
A phase 3
randomized multicenter study to evaluate the efficacy and safety of labumin
interferon alfa-2b (alb-IFN) incombination with ribavirin compared with peg
interferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin
ininterferon alfa naïve subjects with chronic hepatitis C Genotype 2 or 3
achieve-2/3 protocol No-HSG/008-C1067
|
Dr. Samir
R Shah
|
Mumbai
|
-
|
IEC/07/05
|
A phase 3
randomized multicenter study to evaluate the efficacy and safety of albumin
interferon alfa-2b (alb-IFN) in combination with ribavirin compared with
peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin
in interferon alfa naïve subjects with chronic hepatitis C Genotype 1 Achieve
1 Protocol No:HGS/008-C1060
|
Dr. Samir
R Shah
|
Mumbai
|
-
|
IEC/07/06
|
01-06-TL-3220PI-002
A multicenter double blind study to determine the efficacy and safety of SYR-322
plus pioglitazone HCL (ACTOS) SYR-322 alone or pioglitazone HCL alone in
subjects with type 2 diabetes.
|
Dr.
Vyankatesh Shivane
|
RHIDEM,
Mumbai
|
-
|
IEC/07/07
|
BMS study CV185030 – a phase 3 active
warfarin controlled randomized double-blind parallel arm study to evaluate
efficacy and safety of apixaban in preventing stroke and systemic embolism in
subjects with non valvular atrial fibrillation.
|
Dr. V.Dayasagar
Rao
Dr.
Nilesh Gautam
Dr.
R Balaji
Dr.
Sathe
|
--
|
-
|
IEC/07/08
|
TIMACS
study protocol May 17, 2005 an international randomized trial of early versus
delayed invasive strategies in patients with non-st segment elevation acute
coronary syndromes and study related documents.
|
Dr. Sudhir
Verma
|
Patiala
|
-
|
IEC/07/09
|
E2090-E044-310
a randomized multicenter double-blind study to compare the efficacy and
safety of zonisamide and carbamazepine as monotherpy in newly diagnosed
partial epilepsy.
|
Dr. Satish
Jain
|
--
|
-
|
IEC/07/10
|
A 16 week
open label outpatients randomized parallel study assessing the impact of two
different initial dose prescription for dry powder inhaled insulin (exubera
®) on glycemic control in patients with type 2 diabetes mellitus who are
poorly controlled on a combination of 2 or more oral agents.
|
Dr. Vyanketesh
Shivane
|
RHIDEM,
Mumbai
|
-
|
IEC/07/13
|
Protocol
P04229- a randomized, placebo-controlled efficacy and safety of 1-year
treatment duration with high and medium-dose Inhaled
momestasone-furoate/formoterol combination formulation compared with
formoterol and high-dose Inhaled mometasone furoate monotherapy in subjects
with moderate to severe COPD.
|
Dr.
PradeepMehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/07/14
|
Study
04334- a 26-week, placebo-controlled efficacy and safety study of mometasone
furoate/formoterol famarate combination formulation compared with mometasonefuroate
and formoterol monotherpy in subjects with persistatn asthama previously
treated with medium-dose Inhaled Glucocorticosteroids.
|
Dr.
PradeepMehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/07/15
|
Study
P04073- a 26 week, placebo-controlled efficacy and safety study of
mometasonefuroate/formoterolfumarate combination formulation compared with
mometasone furoate and formoterol monotherapy in subjects with persistant
asthma previously treated with low-dose Inhaled Glucocorticosteroids.
|
Dr.
PradeepMehta
|
Geeta
Bhavan Hospital & Intensive care Unit
Indore
(M.P)
|
-
|
IEC/07/17
|
Protocol ID
:A3841054 Real life experience with caduet evaluating effectivness safety and
tolerability in the management of cardiovascular risk factors (excl study)
|
Dr.
Rajeev Kohli
Dr.
Dabhi
Dr.
Doshi
Dr.
R.K.Singh
Dr.
Chopra
DR
Channa
and
24 additional sites
|
--
|
-
|
IEC/07/18
|
Advancing cessation
of tobacco in valenerable Indian toabacco consuimg youth (activity)
|
Dr. KSrinath
Reddy
|
Hriday, New
Delhi
|
-
|
IEC/07/19
|
Assessing delay
to insulin initiation in type 2 diabetes patients in India in a real world
setting
|
Dr. Talwalkar
|
--
|
-
|
IEC/07/22
|
A long-term
open-label extension study to investigate the long-term safety of
SYR-110332(SYR-322) in subjects with type 2 diabetes.
|
Dr.
Vyankatesh Shivane
|
RHIDEM,
Mumbai
|
-
|
IEC/07/24
|
Protocol A
phase IV, randomized parallel group multicenter study to assess the efficacy
ad the safety of multiple dosing regimens (087-CL-084 study)
|
Dr. S.M.Sheth.
Dr.
Sharad Mehta
|
--
|
-
|
IEC/07/25
|
Safe
implementation of Thrombolysis in stroke in the non EU-world ; an
international observational, post-marketing study of the safety and efficacy
of Thrombolysis in stroke BI trial no.135.317 as per study protocol
2006-06-14
|
Dr. P.Vijaya
|
Guntur, A.P
|
-
|
IEC/07/26
|
CP/01/07 –
A randomized, double-blind, placebo controlled, crossover, multicenter study
to evaluate the efficacy ad safety of zolamitriptan 5mg nasal spray in acute
treatment of migraine.
|
Dr. Chandrashkhar
M
Dr. Ramtek
G.S.
Dr. Ajit
Sowani
Dr.
(Mrs) Avanti Atul Biniwale
|
Pune
|
-
|
IEC/07/27
|
BMS Clinical Study an open label,
randomized, multicenter phase-III trial of dastinib (sprycel®) vs.standard
dose imatinib (400mg) in the treatment of subjects with newly diagnosed
chronic phase Philadelphia chromosome positive chronic myeloid leukemia
|
Dr. M.B.Agarwal
|
Mumbai
|
-
|
IEC/07/28
|
Protocol P
276-001/15/07 ' an open label multicenter phase I/II study to evaluate safety
and efficacy of P276-00 in patients with relapsed and / or relapsed/
refractory multiple myeloma'
|
Dr. M.B.Agarwal
|
Mumbai
|
-
|
IEC/07/29
|
A
randomized, double-blind, parallel-group, multicenter study to evaluate the
retention rate, efficacy, safety and tolerability of carisbamate, topiramate
and levetiracetam as adjunctive therapy in subjects with partial onset
seizures.
|
Dr. Satish Jain
|
New Delhi
|
-
|
IEC/07/30
|
Reliability
and validity of self-reported measures of dietary intake & physical
activity among secondary school students in Delhi, India ( Measuring Dietary
intake among youth in India.
|
Ms.Monika
Arora
|
New Delhi
|
-
|
IEC/07/34
|
Clinical
trial protocol No: SBM/14/07 "A prospective randomized, double-blind,
placebo-controlled, parallel group, multicentre study of Sibutramine in obese
Indian subjects with/without co morbidities in conjunction with lifestyle
modifications
|
Dr.
Manoj Chawla
Dr.
Shailaja Kale
Dr. Vaishali
Deshmukh
Dr. Neeta
Deshpande
|
Mumbai
Pune
Pune
Belgaum
|
-
|
IEC/07/39
|
Study
V00114 CP 302 2A, 'Efficacy and Safety study of the antihistamine V0114 CP
2.5mg in the treatment of perennial allergic rhinitis. Randomised, double-blind,
three arm parallel group study including placebo and active control arm
(levocetrizine 5mg)
|
Dr. S.Z.
Jafrey
|
Indore
|
-
|
IEC/08/01
|
A
survey on perceptions of Asian Investigators on Research Ethics SPAIR
|
Dr.
Sutinder Bindra
|
Mumbai
|
-
|
IEC/08/02
|
A
randomized, double-blind, placebo controlled parallel group efficacy and
safety study of BI 1356 (5mg.administered orally once daily) over 24 weeks in
Type-2 Diabetic patients with insufficient glycaemic control despite
metformin therapy
|
Dr.
Arvind Gupta
|
Jaipur
|
-
|
IEC/08/03
|
A
randomized double-blind, placebo controlled parallel group efficacy and
safety study of BI 1356 (5mg.administered orally once daily) over 24 weeks in
drug naïve or previously treated (6 weeks washout) Type-2 Diabetic patients
with insufficient glycaemic control
|
Dr.
Arvind Gupta
|
Jaipur
|
-
|
IEC/08/06
|
A
phase 2, randomized, open-label, multi-center, therapeutic trial of the
efficacy immunogenicity and safety of GI-5005; an inactivated recombinant
saccharomyces cerevisiae expressing a Hepatitis C virus NS3-Corefusion
protein, combined with pegylated interferon plus ribavirin standard of care
therapy versus standard of care alone, in patients with genotype 1 chronic
Hepatitis C Infection
|
Dr.
Samir R Shah
|
Mumbai
|
-
|
IEC/08/07
|
Randomized
, placebo-controlled, multi-center study to assess the efficacy and safety of
eltrombopag in thrombocytopenic subjects with Hepatitis C virus (HCV)
infection who are otherwise eligible to initiate antiviral therapy
(peginterferon alfa-2a plus ribavirin). ENABLE 1(Eltrombopag to initiate and
maintain interferon antiviral treatment to benefit subjects with Hepatitis C
related liver disease).
|
Dr.
Samir Shah
|
Mumbai
|
-
|
IEC/08/08
|
Protocol
TPL108390 'randomised, placebo-controlled, multi-centre study to assess the
efficacy and safety of eltrombopag in thrombocytopenic subjects with
hepatitis C virus (HCV) infection who are otherwise eligible to initiate
antiviral therapy (peginterferon alfa-sa plus ribavirin)' ENABLE 2
(Eltrombopag to initiate and maintain interferon antiviral treatment to
benefit subjects with Hepatitis C related liver disease)
|
Dr.
Samir Shah
|
Mumbai
|
-
|
IEC/08/10
|
Protocol
No. A6111137 A phase 3, prospective, randomized, double-masked, 12- week,
parallel group study evaluating the efficacy and safety of latanoprost and
timolol in pediatric subjects with glaucoma
|
Dr.
Devindra Sood
|
Delhi
|
-
|
IEC/08/11
|
Addressing
the emerging adolescent obesity in Delhi: A social marketing approach
|
Ms.
Monika Arora
|
Delhi
|
-
|
IEC/08/12
|
A
multi-centre, randomized, open label, two parallel groups, 24 week safety and
efficacy trial in subjects with type 2 diabetes
|
Dr.
Manoj Chawla
Dr.
Rajeev Chawla
Dr. Mangesh
Tiwaskar
|
Mumbai
Delhi
Mumbai
|
-
|
IEC/08/13
|
Study
Protocol PPHM 0702, titled :A Phase II Safety and Efficacy Study of
Bavituximab Plus Paclitaxel and Carboplatin in Patients with locally advanced
or Metastatic Breast Cancer
|
Dr.
K.T. Bhowmik
|
Delhi
|
-
|
IEC/08/14
|
MK-0431-803-01
A phase III, multicentre, double blind randomized study to evaluate safety
and efficacy of the addition of Sitagliptin compared with the addition of
Glimepiride in patients with type 2 diabetes mellitus with inadequate
glycemic control on Metformin
|
Dr.
Tushar Bandgar
|
Mumbai
|
-
|
IEC/08/15
|
International,
multi-center, randomized, double-blind study to compare the overall mortality
in acutely ill medical patients treated with enoxaparin versus placebo in
addition to graduated Elastic Stockings. Protocol No: ENOXA_C_01249.
|
Dr.
R.K. Varma
|
Mumbai
|
-
|
IEC/08/16
|
Lilly
Protocol H7T-MC-TABY (a) A Comparison of Prasugrel and Clopidogrel in
subjects with Unstable Angina / Non-ST-Elevation Myocardial Infarction
(UA/NSTEMI) Acute Coronary Syndrome (ACS) who are medically managed.
|
Dr.
J Narendra
|
Karnataka
|
-
|
IEC/08/17
|
Clinical
Trial Protocol No. AG/26/08 :Double blind, randomized, placebo controlled,
single center, prospective study to evaluate efficacy and safety of AG
Arbutin cream in skin lightening (Melanin reduction) in healthy subjects
|
Dr. Sujay
Kulkarni
|
Mumbai
|
-
|
IEC/08/18
|
A
phase 3, randomized, double-blind, placebo-controlled, multicenter study to
evaluate safety and efficacy of PHX1149T as monotherapy in subjects with type
2 Diabetes mellitus
|
Dr.
Vyankatesh Shivane
|
Mumbai
|
-
|
IEC/08/19
|
South
Asian Systolic Heart Failure Registry
|
Dr. Amit
Vora
|
Mumbai
|
-
|
IEC/08/20
|
Study
OV-1012: Double-blind, placebo-controlled, efficacy and safety study of
Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in patients with Lennox-Gastaut
Syndrome
|
Dr.
Satish Jain
|
Delhi
|
-
|
IEC/08/20-A
|
Study
OV-1004: Safety and effectiveness of open-label Clobazam in subjects with
Lennox-Gastaut Syndrome
|
Dr.
Satish Jain
|
Delhi
|
-
|
IEC/08/22
|
TAK-422_202: A phase 2,
double-blind, randomized, placebo-controlled study of the safety and efficacy
of TAK-422 in subjects with acute coronary syndromes
|
Dr.
J. Narendra
|
Karnataka
|
-
|
IEC/08/23
|
A multinational, multicenter,
randomized, double-blind study comparing the efficacy and safety of AVE5026
with Enoxaparin for the primary prevention of Venous Thromboembolism in
acutely ill medical patients with restricted mobility
|
Dr.
J. Narendra
|
Karnataka
|
-
|
IEC/08/24
|
Protocol
E5555-G000-201, A randomized, double-blind, placebo controlled study of the
safety and tolerability of E5555, and its effects on markers of intravascular
inflammation in subjects with Coronary Artery Disease
|
Dr.
J. Narendra
|
Karnataka
|
-
|
IEC/08/25
|
Protocol
E5555-G000-202, A randomized, double-blind, placebo controlled study of the
safety and tolerability of E5555 and its effects on clinical events and
biomarkers in patients with Non-ST-Segment Elevation Acute Coronary Syndrome
|
Dr.
J. Narendra
|
Karnataka
|
-
|
IEC/08/26
|
A
12 week Phase IV study on subjects with type 2 diabetes who are poorly
controlled (i.e. 6.5<HbA1c<8.5) while on Oral Anti-diabetic
agents
|
Dr.
Sanjiv Shah
Dr.
P.G. Talwalkar
|
Mumbai
Mumbai
|
-
|
IEC/08/27
|
A
randomized, multicenter, placebo-controlled and active reference (Glatiramer
acetate) comparison study to evaluate the efficacy and safety of BG00012 in
subjects with relapsing-remitting multiple sclerosis
|
Dr.
Neeta Mehta
|
Mumbai
|
-
|
IEC/08/28
|
Association
between Tobacco use in Bollywood films and Tobacco use among Indian
adolescents
|
Ms. Monika
Arora
|
Delhi
|
-
|
IEC/08/29
|
A5751031-
Macugen Observational Study
|
Dr.
Sathiyan Karunanithi
Dr.
Shobit Chawla
Dr. Deependra
Singh
Dr.
Ajay Dudani
Dr.
Alay Banker
Dr.
Venkatapathy Narendran
|
Kerala
Lucknow
Gurgaon
Mumbai
Ahmedabad
Coimbatore
|
-
|
IEC/08/30
|
A1501089-
A observational study of patients receiving therapy for Systemic Fungal
Infections
|
Dr.
Omender Singh
|
Delhi
|
-
|
IEC/08/31
|
A
78 week open label extension to trials assessing the safety and efficacy of
BI 1356 (5 mg) as monotherapy or in combination with other anti-diabetic
medications in type 2 diabetic patients
|
Dr.
Arvind Gupta
|
Jaipur
|
-
|
IEC/08/32
|
A5991088-An
observational study of Indian Breast Cancer patients receiving adjuvant
therapy with Aromasin
|
Dr.
Satish Jain
|
Ludhiana
|
-
|
IEC/08/34
|
An
open-label, randomized, multicenter, active-controlled, dose-ranging study to
evaluate the safety and efficacy of albinterferon alfa-2b administered every
4 weeks plus ribavirin in interferon alfa –naïve patients with genotype 2/3
chronic hepatitis C.
|
Dr. Samir
Shah
|
Mumbai
|
-
|
IEC/08/35
|
Fighting
Malaria with Microfinance
|
Dr.
Alessandro Tarozzi
|
Chennai
|
-
|
IEC/08/36
|
Protocol
No. 1218.46: A phase III randomized, double-blind, placebo controlled,
parallel group study to compare the efficacy and safety of twice daily
administration of the free combination of BI 1356 2.5mg plus metformin 500mg
or BI 1356 2.5mg plus metformin 1000mg with the individual components of
metformin and BI 1356 over 24 weeks in drug naïve or previously treated (4
weeks washout and 2 weeks placebo run in) type 2 diabetic patient with
insufficient glycaemic control
|
Dr.
Vyankatesh Shivane
|
Mumbai
|
-
|
IEC/08/39
|
A
randomized, open-label clinical trial for evaluation of safety and efficacy
of Prazosin and Prazosin with scorpion anti-venom combination in patients of
poisonous scorpion sting at Mahad Rural General Hospital Center, Maharashtra,
India
|
Dr. H.S.
Bawaskar
|
Raigad
|
-
|
IEC/08/40
|
Post
Marketing Surveillance of Grafeel ™
|
Dr. Mujtaba
Ali Khan
|
Andhra
Pradesh
|
-
|
IEC/09/02
|
Protocol No. 28850: Open label trial
to determine the long term safety of safinamide in Parkinson's disease
patients
|
Dr. Neeta
Mehta
|
Mumbai
|
-
|
IEC/09/03
|
E2090-E044-314- A randomized,
double-blind extension study to assess the long term safety and to explore
the long-term efficacy of Zonisamide as monotherapy in newly diagnosed
partial seizures
|
Dr. Satish
Jain
|
Delhi
|
-
|
IEC/09/04
|
Consumer
Willingness to pay (WTP) for selected diagnostic tests in three states in
India
|
Dr.
P. P. Talwar
|
Mumbai
|
-
|
IEC/09/05
|
Protocol
H8O-MC-GWCH (a) safety & efficacy of Exenatide once weekly injection
versus metformin, dipeptidyl peptidase-4 inhibitor or Thiazolidinedione as
monotherapy in drug-naïve patients with type 2 diabetes
|
Dr.
Vyankatesh K Shivane
|
Mumbai
|
-
|
IEC/09/06
|
Champix
observational Investigation in the Cessation of smoking
|
Dr.
Matcheswalla
Dr.
Sajid Ali Khan
Dr.
Krishnamurthy Srikanth
Dr. Vimal Kumar
Dr. Pankaj Aneja
Dr. Ketan Mehta
Dr. Jayachandra
|
Mumbai
Mumbai
Tamil
Nadu
Delhi
Delhi
Mumbai
Hyderabad
|
-
|
IEC/09/07
|
Prospective
observational study to assess correlation between glycemic control and
hypoglycemia in patients with type 2 diabetes, treated with sulfonylurea. The
obstacle Hypoglycemia study Protocol No :- 0431_140_01 dtd 20/010/09
|
Dr.
Sanjay Kalra
Dr.
V. Ravindranath
Dr.
Balamurugan
Dr.
K. Hari
Dr.
M.C. Deepak
Dr.
Pichumani
Dr.
M.G. Uvaraj
Dr.
Suresh Kumar
Dr.
Sreejith
Dr.
Satyanarayana
|
Karnal
Tamil
Nadu
Coimbatore
Cochin
Chennai
Chengalpattu
Salem
Malapurram
Trivandrum
Andhra Pradesh
|
-
|
IEC/09/09
|
Randomized
trial comparing sphincteroplasty and lithotripsy for extraction of large bile
duct stones
|
Dr. Amit
Maydeo
|
Mumbai
|
-
|
IEC/09/10
|
Protocol
No. NN 304-1768 "A randomized multinational, open labeled 2 armed parallel
group treat-to-target once daily treatment trial with insulin glargine both
in combination with metformin in subjects with type 2 diabetes
|
Dr.
Nallaperumal
Dr.
Jothydev
|
Chennai
Kerala
|
-
|
IEC/09/11
|
Impact
evaluation of rural sanitation campaign in Madhya Pradesh and Himachal
Pradesh - Baseline and Follow-up study
|
Dr. P.P.
Talwar
|
Delhi
|
-
|
IEC/09/12
|
MV22009
– A multicentre, prospective, observational, non-interventional cohort study
evaluating on – treatment predictors of response in subjects with HBe Ag
positive or HBe Ag negative chronic Hepatitis B receiving therapy with
PEGASYS ® (Peginterferon alfa-2a 40 KD under F Hoffmann La Roche Ltd.)
|
Dr. Samir
Shah
|
Mumbai
|
-
|
IEC/09/13
|
Safety
and efficacy of TRC4186 in the treatment of stable heart failure associated
with HbA1c ≥ 6.5% or type 2 diabetes receiving oral hypoglycaemic
therapy (with or without additional insulin) as an add-on to conventional
treatment for heart failure.
|
Dr. V.P.
Sharma
|
Jalandhar
|
-
|
IEC/09/14
|
Retrospective
chart analysis of subjects with a history of threatened abortion/miscarriage
– feasibility evaluation
|
Dr.
Parikshit Tank
|
Mumbai
|
-
|
IEC/09/15
|
Comparison
of Insulin Lisprow low-mixture and mid-mixture regimens with separate basal
and bolus insulin injections in patients with type 2 diabetes with inadequate
glyccemic control on oral therapy who consume light breakfast introduction[
F3Z-EW-S020(d)]
|
Dr. Manoj
Chawla
|
Mumbai
|
-
|
IEC/09/16
|
Efficacy
and safety of two fixed doses (160 OR 320 mg/day) of ralfinamide in patients
with chronic neuropathic low back pain. A mulitcenter, double-blind,
randomized, placebo-controlled 12-week study with long-term extension
|
Dr. Neeta
Mehta
|
Mumbai
|
-
|
IEC/09/17
|
Protocol
OMB110911: A phase III, open-label, randomized, multicenter trial of
Ofatumumab-Chlorambucil combination vs. Chlorambucil Monotherapy in
previously untreated patients with Chronic Lymphocytic Leukemia
|
Dr. Usha
Agarwal
|
Mumbai
|
-
|
IEC/09/18
|
TPL104054 A randomized, double-blind,
placebo-controlled, multicenter study to evaluate the safety and efficacy of
Eltrombopag to reduce the need for platelet transfusion in thrombocytopenic
subjects with Liver Disease undergoing elective invasive procedures
|
Dr. Samir
Shah
|
Mumbai
|
-
|
IEC/09/19
|
TRA 108132 LENS-Long term Eltrombopag
observational study-A long term observational ocular safety follow-up study
in adults who have received study medication (SB-497115 GR eltromobopag
olamine or placebo) in a phase II or III clinical study evaluating
eltrombopag
|
Dr. Samir
Shah
|
Mumbai
|
-
|
IEC/09/20
|
Strengthening
Indian tobacco control legislation to be compliant with FCTC through advocacy
and evidence based recommendations
|
Ms. Monika
Arora
|
Delhi
|
-
|
IEC/09/22
|
Multicentric
Trial on Immunogenecity of Single Dose Live Attenuated Hepatitis-A Vaccine Biovac-A™,
2 year Follow Up
|
Dr. Nitin
Shah
|
Mumbai
|
-
|
IEC/09/23
|
Protocol
No. 1218.52 A phase III randomized, double-blind parallel group extension
study to investigate the safety and efficacy of twice daily administration of
the free combination of linagliptin 2.5 mg + metformin 500 mg or of
linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000
mg twice daily over 54 weeks in type 2 diabetic patients previously
completing the double-blind part of the study 1218.46
|
Dr.
Vyankatesh Shivane
|
Mumbai
|
-
|
IEC/09/24
|
Protocol
No. 1218.61 A phase III, randomized, double-blind, placebo-controlled
parallel group efficacy and safety study of Linagliptin 5 mg administered
orally once daily over 24 weeks in type 2 diabetic patients with insufficient
glycaemic control despite a therapy of metformin in combination with
pioglitazone
|
Dr. Tushar
Bandgar
|
Mumbai
|
-
|
IEC/09/27
|
Phase
II multicenter, prospective, randomized, age related macular degeneration
comparator controlled dose ranging study evaluating PF-04523655 versus
Ranibizumab in the treatment of subjects with Choroidal Neovascularization
(MONET Study)
|
Dr. Alay
Banker
|
Mumbai
|
-
|
IEC/09/28
|
A
multicenter, randomized, double-blind, parallel group, placebo controlled
study to evaluate the efficacy and safety of PEGylated interferon beta-2a
(BIIB017) in subjects with relapsing multiple sclerosis
|
Dr. Pawan
Ojha
|
Mumbai
|
-
|
IEC/09/29
|
A
mullticenter, double-blind, randomized, placebo controlled study to asses the
long term safety and efficacy of two fixed doses of ralfinamide (160 or 320
mg/day) in patients with Chronic Neuropathic low back pain
|
Dr. Neeta
Mehta
|
Mumbai
|
-
|
IEC/09/34
|
A
multi-centre, multi-national, randomized, placebo-controlled, parallel group,
double-blind, phase III trial to evaluate the efficacy & safety of
LC15-0444 in patients with type 2 diabetes
|
Dr.
Vyankatesh Shivane
|
Mumbai
|
-
|
IEC/09/35
|
A
multi-centre, multi-national, randomized, active-controlled, parallel group,
double-blind, phase III trial to evaluate the efficacy & safety of
LC15-0444 compared with Sitagliptin added to ongoing Metformin therapy in
patients with type 2 diabetes inadequately controlled with Metformin alone
|
Dr.
Vyankatesh Shivane
|
Mumbai
|
-
|
IEC/10/01
|
A
phase III, randomized, comparative, open-label, study of Intravenous Iron
Isomaltoside 1000 (Monofer ®) administered by infusions or repeated bolus
injections in comparison with oral Iron Sulphate in subjects with
Non-Dialysis Dependent Chronic Kidney Disease and with Renal-Related Anaemia
|
Dr. Rajesh
Kumar
|
Mumbai
|
-
|
IEC/10/02
|
A
trial investigating the efficacy and safety of NN1250 compared to insulin
detemir in subjects with type 1 diabetes mellitus in a basal/bolus treatment
regimen
|
Dr. Rajeev
Patni
|
Jaipur
|
-
|
IEC/10/03
|
Study
code: SYR-322MET_302 A multicenter, randomized, double-blind, placebo
controlled study to determine the efficacy and safety of Alogliptin plus
metformin, Alogliptin alone or metformin alone in subjects with type 2
diabetes
|
Dr.
Tushar Bandgar
Dr. Shehla
Shaikh
|
Mumbai
Mumbai
|
-
|
IEC/10/06
|
A
randomized, open-label, parallel arm, Noninferiority comparison of the
effects of two doses of LY2189265 and Insulin Glargine on glycemic control in
patients with type 2 diabetes on stable doses of Metformin and Glimepiride;
Protocol H9X-MC-GBDB
|
Dr.
Vyankatesh Shivane
Dr. Manoj
Chawla
|
Mumbai
Mumbai
|
-
|
IEC/10/07
|
A
multicenter, double-blind, randomized, vehicle-controlled, parallel-group
study comparing Clindamycin Phosphate (1.2%) and Tretinoin (0.025%) Topical
Gel (Actavis Mid-Atlantic LLC) to Ziana® (Clindamycin phosphate 1.2% and
Tretinoin 0.025%) Gel (Medicis, The Dermatology Company®) and both active
treatments to Clindamycin phosphate (1.2%) and Tretinoin (0.025%) Topical Gel
Placebo (Actavis Mid-Atlantic LLC) in the treatment of mild to severe acne
vulgaris
|
Dr. Kiran
Godse
|
Mumbai
|
-
|
IEC/10/08
|
Multicenter,
double-blind, randomized, parallel-group, monotherapy, active-control study
to determine the efficacy and safety of Daclizumab High Yield Process (DAC
HYP) versus Avonex® (Interferon ßIa) in patients with Relapsing Remitting
Multiple Sclerosis
|
Dr. Neeta
Mehta
|
Mumbai
|
-
|
IEC/10/09
|
Efficacy
and safety assessment of T2345 unpreserved eyedrops versus Xalatan in ocular
hypertensive or glaucomatous patients. Phase III study international,
multicentre, randomized, investigator-masked, 2 parallel group versus
reference product in 360 evaluable patients treated for 3 months
|
Dr. Rita
Dhamankar
|
Raigad
|
-
|
IEC/10/10
|
Protocol
No: CA182-033 A randomized, double-blind, multicenter, phase III study of Brivanib versus Sorafenib as First-line treatment in patients with Hepatocellular
Carcinoma (The BRISK FL Study)
|
Dr. Samir
Shah
|
Mumbai
|
-
|
IEC/10/11
|
H9X-MC-GBDC
the impact of LY2189265 versus metformin on glycemic control in early type 2
diabetes mellitus (AWARD-3: Assessment of weekly administration of LY2189265
in diabetes-3)
|
Dr.
Vyankatesh Shivane
Dr. Manoj
Chawla
|
Mumbai
Mumbai
|
-
|
IEC/10/12
|
A
multi-centric study for measurement of chronic disease risk factors in India
|
Dr.
Wasundhara Joshi
|
Mumbai
|
-
|
IEC/10/13
|
A
multicentre, interventional, comparative study to evaluate the percentage
change in transmission of Hepatitis-C Virus (HCV) infection by empowering
patients with awareness and ensuring continuous usage of gloves in
haemodialysis unit
|
Dr. Samir
Shah
|
Mumbai
|
-
|
IEC/10/15
|
Baseline
and Endline evaluation of Healthy Lokshakti Project, Bhavishya Alliance.
"Healthy Lokshakti" – Strengthening Maternal & Child Health Services
|
Dr. Hemlata
S.Kulkarni
|
Aurangabad
|
-
|
IEC/10/16
|
A
multicenter, randomized, parallel group, double-blind, placebo and active
controlled phase 2 dose finding study comparing the safety, tolerance and
efficacy of various doses of SK-0403 versus placebo and Sitagliptin 100mg in
patients not well controlled on metformin therapy
|
Dr.
Vyankatesh Shivane
|
Mumbai
|
-
|
IEC/10/17
|
RESOLUTE ASIA: Evaluation of the endeavor resolute zotarolimus-eluting stent system in a patient
population with long lesion(s) and/or dual vessels inAsia
|
Dr. Jagdish
Parikh
|
Mumbai
|
-
|
IEC/10/18
|
Multicentric
trial on persistence of Immune responses of anti-HAV in children vaccinated
with live attenuated Hepatitis A vaccine Biovac-A™ upto 5 years
|
Dr. Nitin K
Shah
|
Mumbai
|
-
|
IEC/10/19
|
Exploring
Health Attitudes and Perceptions in India (EHAPI) A youth study
|
Ms. Monika
Arora
|
Delhi
|
-
|
IEC/10/21
|
Assessment
of causality between exposure to tobacco use in Bollywood movies and Tobacco
use among Indian Adolescents
|
Ms. Monika
Arora
|
Delhi
|
-
|
IEC/10/22
|
Protocol
Number MSDC-C004, "A phase 2B, randomized, double blind, comparator and
placebo controlled, dose ranging study to evaluate the safety, tolerability
and efficacy of three dose levels of MitoglitazoneTM in type 2
diabetic patients
|
Dr.
Vyankatesh Shivane
|
Mumbai
|
-
|
IEC/10/25
|
A
multicentre, randomized, open label, parallel_group phase IIB study on the
efficacy and safety of oral regimens of DEB025 alone or in combination with
ribavirin versus Standard of Care (peg-IFNα2a plus ribavirin) in
treatment naïve hepatitis C genotype 2 and 3 patients
|
Dr. Samir R
Shah
|
Mumbai
|
-
|
IEC/10/26
|
A
controlled in House application study to determine the skin moisturization
potential of Quinoa Pro Ex, Amino Silk, Barla Tein Pro and Rice Pro-Tein Bk
in Leave on Products through capacitance and Diffusion methodology
|
Ms.Ashwini
Ballal
|
Mumbai
|
