Completed Trials-List

Completed Trials:

SL.NO

Title

Investigator/Sub I/ CRC

1.       

Protocol Title: A multicentric randomized , comparative clinical trial to assess the immunogenicity and reactogenicity of DPTw [meat free] vaccine with standard commercially available DPTw [routine] vaccine both manufactured by serum institute of India Ltd, pune in Indian children aged 6 –14 weeks”.

Serum Institute

Dr. V.D.PatilPI

Dr. Girija Ashtagi–Sub-I 

Dr. Arun – CRC

2.       

Protocol Title: To Study the safety and efficacy of R-TPR –001 (Reteplase- Recombinant plasminogen activator) in patients with acute myocardial infarction and ST segment elevation”.

 Reliance

Dr. V.A. KothiwalePI

3.       

Protocol Title: EX 1000-1919: A multicentre, multinational, randomized, open labeled, two armed, parallel group trial with a 24 week treatment period comparing the efficacy and safety of two concentrations of Mixtard 30 (333IU/mL) or Mixtard 30 (1000IU/mL)”.

 Novonordisk

Dr. M.V. Jali- PI

4.       

Protocol Title: A Phase III , Multicenter, Randomized , Double – Blind Study To Evaluate The Efficacy And Safety Of Sitagliptin Versus Glipizide In Patients With Type 2 Diabetes Mellitus And Chronic Renal Insufficiency Who Have Inadequate Glycemic Control”

SMO India.

Dr. M. V. Jali– PI

5.       

Protocol Title: “CRASH-2” a large randomized placebo controlled trial among trauma patients with, or at risk of, significant hemorrhage of the effects of antifibrinolytic treatment on death and transfusion requirement

“WHO”.

Dr. Ashok Pangi- PI

6.       

Protocol Title: “A multicentric, randomized comparative clinical trial to assess the immunogenicity and tactogenicity of DTPw Hib (absorbed0 vaccine (PRP>10MG).

 “Serum Institute of India, Pune”.

Dr. V.D.Patil– PI

7.       

Protocol Title: “BC-06: A double-blind, randomized, multiple dose, phase III, multi-centre study of Alpharadin TM in the treatment of patients with hormone refractory prostate cancer with skeletal metastases”.

Dr. R.B. Nerli– PI

 

8.       

Protocol Title: “F1K-MC-EVDP, Efficacy and safety of Drotrecogin Alfa [activated] in adult patients with septic shock”.

Parexell

Dr. V.A. Kothiwale – PI

 

9.       

Protocol Title: A Phase IV Multicentric, Randomized, comparative clinical trial to assess the immunogenicity and Reactogenicity of two different lots of DTwPHB+Hib (Pentavac) vaccine manufactured by “Serum Institute of India Ltd., Pune”

 

Dr. V.D.Patil– PI

10.  

Protocol Title: “Multi-Center, Double Blind, Randomized, Controlled, Parallel Comparison of Efficacy and Safety of Fixed Doses of Two Formulations of Botulinum Toxin Type A in Treatment of Moderate to Severe Cervical Dystonia (BOTOX-200 Units and DYSPORT 500 Units) –

Dr. G.M. Wali– PI

 

11.  

Protocol Title: To study the safety and efficacy of R-HSC-001 in patients with Spinal Cord Injury    

Reliance

Dr. Raviraj Ghorpade- PI

12.  

Protocol Title: Comparison of measurement of arterial blood pressure by L&T NIBP module with Invasive arterial blood pressure in neonates

Dr. (Mrs.) Manisha Bhandankar- PI

 

13.  

Protocol Title: A randomized, Multicentric, double blind, comparative, phase III study to evaluate the safety and immunogenicity of BBIL’s Monovalent poliomyelitis vaccine type 3 live (oral) Vs reference vaccine in healthy neonates.(Non-Inferiority trial)

Dr. (Mrs) N.S. Mahantshetti- PI

14.  

Protocol Title: A randomized, Multicentric, double blind, comparative phase III study to evaluate the safety and immunogenicity of BBIL’s Bivalent poliomyelitis vaccine type 1 & 3 live (oral) Vs reference vaccine in healthy neonates. (Non-Inferiority trial)

Dr. (Mrs) N.S. Mahantshetti- PI

 

15.  

Protocol Title: BBIL/POL/04/2007 “A Randomized, Multi Center, Double Blind, Comparative Phase III study to evaluate the Safety and immunogenicity of BBIL’s Monovalent Type 1 Oral Polio Vaccine Vs Pre-qualified Trivalent Oral Polio Vaccine in healthy Neonates. (Non- Inferiority Trial)”

Dr. (Mrs) N.S. Mahantshetti- PI

16.  

Protocol Title: To study the safety and efficacy of ReliDerm®DT in patients with chronic diabetic foot ulcer

(Reliance)

Dr. V.A. Kothiwale- PI

17.  

Protocol No: 28431754DIA3008 “A randomized, double-blind, parallel, placebo-controlled, multicenter study of the effects of JNJ-28431754 on cardiovascular outcomes in adult subjects with type 2 diabetes mellitus. The CANVAS trial (CANagliflozin Cardiovascular Assessment Study)”.             “George Institute”

Dr. V.A. Kothiwale- PI

18.  

Protocol Title: Effects of Naturlose (Tagatose) on Glycemic Control and Safety of Naturlose Over One Year in Subjects with Type 2 Diabetes under Diet Control and Exercise. “

“Manipal Acunova”

Dr. Jayaprakash, A – PI

 

19.  

Protocol Title: “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” Reliance

 

 

Dr. Rekha Patil – PI

Dr. B. Shrinivas – Sub I

Dr Jayaprakash A – Sub I

20.  

Protocol No. MK-0431-229-00: A Phase III Randomized Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination with Metformin

“Merck & Co” – Company

Dr. M.V. Jali – PI

Dr.Sanjay kambar– Sub I

Dr. Sujata Jali – CRC

 

20.

Protocol Title: “A Phase III, randomized, multicenter, controlled study to evaluate the immunogenicity and safety of BBIL’s Typhoid Vi Capsular Polysaccharide – Tetanus Toxiod protein conjugate vaccine Vs reference vaccine in healthy subjects”.

Bharat Biotech” – Company.

Dr.N.S.Mahantshetti- PI

21.

Protocol Title: A Multicentric double blind single arm randomized phase IV study to evaluate the safety, reactogenicity and lot consistency of three production lots of BE’s combined liquid Pentavalent DTwP-rHepB-HIB vaccine administered at 6-10-14 weeks schedule to 6-8 week old healthy Indian infants.

Biological E. Limited” – Company

Dr.V.D.Patil – PI

Dr R. M Wali – Sub I

      22.

Protocol No: GLP114130: “A randomized, double-blind, active-controlled, parallel group,multicenter study to determine the efficacy and safety of Albiglutide as compared with Sitagliptin in subjects with type 2 diabetes mellitus with renal impairment”

SMO India – CRO

Dr M.V. Jali – PI

Dr.Sanjay Kambar– Sub I

Dr. Prashant – CRC

23.  

Protocol Title: A Prospective Multicenter Observational Study to Characterize the Patient Population with Cholestasis in Chronic Liver Disease due to Non-Alcoholic Liver Disease Receiving Heptral in India[P13-163]

(Abbott)

Dr. Santosh Hajare-PI

Dr.Prakash– Sub-I

24.  

Protocol Number: PBL/CR/0032008/CT “A randomized, multicenter, open label, comparative study to evaluate the Immunogenicity and Reactogenicity of a new fully liquid Pentavalent DTwP-Hib-IPV vaccine (EasyfourPol™, Panacea Biotec Ltd) with tetravalent DTwP/Hib vaccine (TetrAct-Hib™), co-administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine) of Sanofi Pasteur India Pvt. Ltd. In Healthy Infants.

Panacea” – Company

Dr. S. M. Dhaded – PI

 

Dr.Preeti Amarkhed–Sub I

25.  

Protocol No: MB102073: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel group, Phase III Trial to evaluate the Safety and Efficacy of Dapagliflozin in subjects with Type 2 Diabetes with inadequately controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker”.

“ICON” – Company

Dr. Rekha. Patil – PI

Dr. Jayaprakash A – Sub I

26.  

Protocol No: MB102077: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III trial to Evaluate the Safety and Efficacy of Dapagliflozin in subjects with Type @ Diabetes with Inadequately Controlled Hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

“ICON” – Company

Dr. Jayaprakash. A –PI

Dr. Rekha. Patil – Sub I

27.  

Protocol Number: MK-0822: Phase III Randomized, Placebo –Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Post menopausal Women Treated With Vitamin D and Calcium.

Clinigene International Ltd

Dr.Rajendra.Bhandankar-  PI

 Dr. Sudheer Yadwad–  Sub I

 Dr. Ashwini Hiroji – CRC

28.  

Protocol Title: “A Multicentre, Comparative, Controlled, Open Label, Randomized, Parallel Group, Phase III Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Containing Rosuvastatin Calcium with Amlodipine Besylate versus Monotherapy for Stage 1 and Stage 2 Hypertension in Dyslipidemic patients”.G7 study

(BIOCON)                                                                     

Dr .V. A. Kothiwale – PI

Dr.Varun– Sub-I 

29.  

Protocol Number: DU176b-C-U305:A phase3, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multi-Center, Multi-National study for the Evaluation of efficacy and safety of (LMW) Heparin/Edoxaban versus (LMW) Heparin/Warfarin in subjects with symptomatic deep-vein thrombosis and/or Pulmonary Embolism

 (Quintile) – Company

Dr. V.A. Kothiwale – PI

Dr.Madhav Prabhu–Sub I

30.  

Protocol Number: DU176b-C-U301: A Phase 3, Randomised, Double-Blind, Double Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects with Atrial Fibrillation- Effective aNticoaGulation with Factor xA Next Generation in Atrial Fibrillation (ENGAGE– AF TIMI – 48)

(Quintile) – Company

Dr. V.A. Kothiwale – PI

Dr. Ranjan Modi – Sub I

31.  

Protocol Title: A phase III, open-label, randomized, multicenter study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexaTM) administered to Indian infants according to 6-10-14 weeks and a 2-4-6 months schedule”.

“GlaxoSmithKline”- Company

Dr.(Mrs) N.S.Mahantshetti -PI

 

 Withdrawn before & after approval:

SL.NO

Title

Investigator/Sub I/ CRC

1.       

Protocol Title: An Uncontrolled, Open-Label, Titration, long term Safety (up to 12 months) and efficacy study of Tamsulosin Hydrochloride in Children with Neuropathic Bladder, with a Randomized Pharmacokinetic Sub-Study Investigating Low, Medium and High dose Ranges

Dr. R. B. Nerli– PI

2.       

Protocol Title: “Protocol L1K-MC-GLUD(e) – Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2405319 after Multiple Subcutaneous Injections in Subjects with Type 2 Diabetes”

Dr. Neeta Deshpande– PI

3.       

Protocol Title: A randomized , double – blind, placebo-controlled, multicentre prospective dose finding phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lumps erythematosus [SLE]

Dr. Arun shrivastava– PI

4.       

Protocol NC25608 (dal-OUTCOMES 2): “A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, parallel Group, study to evaluate the effect of Dalcetrapib 600mg on Cardiovascular at elevated risk for cardiovascular diseases (CVD)

(Quintile) CRO

Dr .V. A. Kothiwale – PI

Dr. Aditya. Kulkarni–Sub-I 

5.       

Protocol Title: A Randomized, Open Label, Single Period, Single Treatment Controlled Study Of Comparing Safety And Reactogenecity Of Bcg Vaccine Of Green Signal Bio Pharma Private Limited India With Bcg Vaccine Of Serum Institute Of India Limited (Sil), India In 120 Healthy Children. Quest Life sciences.

Serum Institute Of India Limited

Dr. Sujata Jali- PI

6.       

Protocol Title: “Genetic Association Study of ATP-binding cassette transporter 1 (ABCA1) Polymorphisms and the risk of Coronary Heart Disease (CHD) in Indian Population”

Dr. Shivaraj Gowda- PI

7.       

Protocol Title: “A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicentre study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Partial Onset Seizures Followed by an Open-label Extension study”

Dr. Ravishankar Naik- PI

8.       

Protocol No: 28431754DIA3008 “A randomized, double-blind, parallel, placebo-controlled, multicenter study of the effects of JNJ-28431754 on cardiovascular outcomes in adult subjects with type 2 diabetes mellitus. The CANVAS trial (CANagliflozin Cardiovascular Assessment Study)”.

Dr .V. A. Kothiwale – PI

9.       

Protocol No KP231: Double-blind, randomized, placebo-controlled study to evaluate the efficacy of Bacillus subtilis strain PB6 in the prevention of antibiotic-associated diarrhea (AAD) in hospitalized subjects receiving antibiotic therapy “

“KEMIN” – company

Dr.Vijay. G Somannavar – PI

Dr.Madhav Prabhu – Sub I

Dr.M S  

10.  

Protocol Number: 1218.60: “A randomised, double-blind, double dummy, active-comparator controlled study investigating the efficacy and safety of linagliptin co-administered with metformin QD at evening time versus Metformin BID over 14 weeks in treatment naïve patients with type 2 diabetes mellitus and insufficient glycaemic control”.

“SHAN”Pharmaceuticals

Dr. Jayaprakash Appajigol-PI

Khoremand Bhathena-CRC

Atul.Aggrawal-CRC

11.  

MK-6621 Protocol – 010: “A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients with Atrial Fibrillation”.

“ICON” – Company

Dr .V. A. Kothiwale – PI

Dr. Varun – Sub I

12.  

Protocol Number BC22140 ALEGLITAZAR (RO0728804): Phase 3 Multicenter,randomized, double-blind, parallel group, placebo controlled study Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ASC) event and type 2 diabetes mellitus (T2D)

 “George Institute” -CRO

Dr. M.V. Jali – PI

Dr. Suresh Patted – Sub I

13.  

Study Title: A Phase III Prospective, Randomized, Open labelled, Multicentric, Parallel group, three arms Clinical Study to evaluate the Efficacy and Safety Between Monotherapy of Glenmark’s Roflumilast 500mcg tablet and combination therapy of Roflumilast 500mcg tablet plus Tiotropium 9mcg inhalation and combination therapy of Roflumilast 500mcg tablet plus Salmeterol 25mcg Inhalation in Adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Glenmark”

Dr. Vinayakumar. K.

Mahishale-PI

14.  

Protocol No:RLS/TP/2010/03:“Prospective, Multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-004 in patients undergoing treatment for Acute Ischemic Stroke”

Reliance

Dr.Ravishankar Naik – PI

Dr. Saroja A.O – Sub I