Ongoing Trials-List

List of Ongoing Trials –

SL.NO

Title

Investigator /Sub I/ CRC

1.       

Protocol Number: AMR-01-01-0019: “A Multicenter, prospective, randomized, double blind, placebo-controlled, parallel-group study to evaluate the effect of AMR101 on cardiovascular health and mortality in hypertriglyceridemic patients with cardiovascular diseases or at high risk for cardiovascular diseases: REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial)

(Pharmanet) CRO

Dr .V. A. Kothiwale – PI

 

2.       

Protocol Title: “A proof of concept, parallel design, single treatment, double arm trial of 50 mg quick dissolve tablets containing freeze dried Lactobacillus delbrueckii subsp. bulgaricus lysate (GenCixTM) from FraXon technologies Inc., USA, conducted on treatment naïve chronic hepatitis C positive patients in one arm and treatment naïve chronic hepatitis C positive patients on dialysis in the other arm” 

(Norwich)

Dr .V. A. Kothiwale – PI

 

3.       

Protocol Number: GPL-CT/2011/lII A Phase III, Randomized, Open Label, Non- Inferiority, Active-Controlled Comparative, Parallel Group, Multicentric Study of Fixed Dose Combination of Formoterol 12 μg Plus Fluticasone 250 μg as DPI (Test Drug) with the commercially available Fixed Dose Combination of Salmeterol 50μg and Fluticasone250 μg (SeretideTMAccuhalerTM 50/250 μg) as DPI in a 12-week Treatment Period of Adolescent and Adult Subjects With Moderate-Severe Stable Persistent Asthma” 

Glenmark”

Dr. Gajanan.S.Gaude –  

 

 

4.       

Protocol Title – C003 – A Double Blind, Randomized, Placebo Controlled, Parallel Group, Three Arm, Multicenter And Multinational Pivotal Study To Assess The Efficacy And Safety Of Two Dosage Regimens Of Crofelemer Tablets In The Treatment Of Moderate To Severe Acute Watery Diarrhea In Adult Patients.

“Glenmark” – Company

Dr.Vijay.G Somannavar –PI

Dr Madhav prabhu-Sub I

 

 

5.       

Protocol Title –“A phase II/III randomized, single blinded, active controlled study to evaluate the immunogenicity and safety of inactivated Japanese encephalitis vaccine in healthy volunteers”.

“Bharat Biotech” – Company.

Dr.N.S.Mahantshetti-PI

Dr. Joshi- Sub-I

6.       

Trial No: BECT/JEV-PII-III/018, Protocol No: BECT018/JEV-PII-III/CTP-02 “A Multicentric, Open Label Randomized Controlled Phase II/III Study to Evaluate the Safety and Immunogenicity of BE’s Inactivated JE Vaccine in Healthy ≥ 1 to <3 year Old Indian Children

“Biological E. Limited” – Company

Dr. V.D.Patil – PI

Dr. Preeti Amarkhed-Sub I

 

7.       

Protocol Title: A phase II, Randomized, Open Label, Single Subcutaneous dose study of Polysialylated Erythropoietin to assess safety, pharmacodynamic & Pharmacokinetics in chronic kidney disease patients not on dialysis.

 Clinigene, International Ltd

Dr. M. Khanpet – PI

Dr. Vinayak Ekbot – Sub I

 

8.       

Protocol Number TRI08888 GARFIELD: “Prospective, multicentre, international registry of male and female patients newly diagnosed with atrial fibrillation”.

“Thrombosis Research Institute”

Dr .V. A. Kothiwale – PI

Dr. M. S. Ganachari

9.       

Protocol Study Number: SH501:“Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5 (DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD when administered as a Single Booster Dose at 15-18 months and Three Dose at 6-8,10-12 and 14-16 Weeks of Age in Healthy Indian Children and Infants”

“SHAN”Pharmaceuticals

Dr.S.M.Dhaded-PI

Dr.Preeti Amarkhed–Sub I

 

10.  

Protocol Number: GPL/CT/2012/III: A Randomised, Double-Blind, Comparative, Prospective, Multicentre, Parallel study to assess Efficacy, Safety and Tolerability of Repaglidine/Metformin IR Tablet Monotherapy or Repaglidine Tablet Monotherapy in Adult patients with Type 2 Diabetes Mellitus Inadequately controlled on Metformin Alone”.“Glenmark”

Dr.M.V. Jali –PI

 Dr.Sanjay.Kambar– Sub I

Dr.P.A.Kadam-CRC

Dr.Vinayak.S-CRC

 

 

11.  

Protocol Number: CV181169 :A Multicentre, Randomised, Double-Blind, Active-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety of Add-On Therapy with Saxagliptin and Dapagliflozin added to Metformin compared to Add-On Therapy with Saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone.

“ICON” Clinical Research- Company

Dr. M.V. Jali –PI

 

12.  

Protocol Number: GRC17536-203: A Phase 2, 4-Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy. Submitted by – Dr M.V. Jali, Principal Investigator, M.D. & CEO KLE’s Prabhakar Kore Hospital and Medical Research Center, Belgaum.

Glenmark”

Dr. M.V. Jali –PI

 

13.  

Protocol Number: P2202/47/10:A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Two-Staged, Fixed Design Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Overweight/Obese Patients of Type 2 Diabetes Mellitus Inadequately Controlled on Metformin, Sulphonylurea, or Both. Submitted by – Dr M.V. Jali, Principal Investigator, M.D. & CEO KLE’s Prabhakar Kore Hospital and Medical Research Center, Belgaum.

“Piramal Healthcare”

Dr. M.V. Jali –PI

 

14.  

Protocol No: 20110118:“A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is used in Combination with Statin Therapy in Patients with Clinically Evident Cardiovascular Disease”.

Amgen Technology Pvt.ltd

Dr .V. A. Kothiwale – PI

 

 

15.  

Protocol No:CLR_10_22:“Efficacy and safety of SPIL”s Lubriprostone capsule, 24 mcg Lubriprostone in subjects with Chronic Idiopathic Constipation :A Randomized, Double blind, Parallel group, Active and Placebo Controlled, Clinical Endpoint Bioequivalence Study ”.

ZYDUS

Dr.Santosh Hajare-PI

16.  

Protocol No: ZYH 1.12.001.01 PROT: “A Multicenter, prospective, randomized, open label Phase IV clinical study to evaluate the safety and efficacy of Saroglitzar (ZYH1) as compared to fenofibrate in patients with dyslipidemia”.

SUN PHARMA

Dr. Jayaprakash Appajigol-PI

 

17.  

Protocol Title: A demonstration Project to Evaluate the effectiveness and Acceptability of the Joint Diabetes Evaluation (JADE) & DIAbetes MONitoring Database(DIAMOND) Programs in Type 2 Diabetes Patients in India (JADE Diamond)

Dr. M.V. Jali –PI

 

18.  

Protocol Title: Protocol I4V-MC-JADX: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis.

ELI LILLY

Dr.Udapudi-PI

Dr.Mahantesh Patil– Sub I

 

19.  

Protocol Title: Protocol I4V-MC-JADZ– A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have had Limited or No Treatment with Disease Modifying Antirheumatic Drugs.

ELI LILLY

Dr.Udapudi-PI

Dr.Mahantesh Patil–  Sub I    

 

20.  

Protocol SB2-G31-RA: A Randomized, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy.

Dr.Rajendra.Bhandankar PI

Dr.Sudheer Yadwad–               Sub I

 Dr.Kshitija-CRC

21.  

Protocol I4L-MC-ABEL: A Prospective, Randomized, Open-Label comparison of a long acting Basal Insulin Analog,LY2963016, to Lantus® in combination with Mealtime Insulin Lispro in Adult Patients with Type 1 Diabetes Mellitus: The ELEMENT 3 study

Dr. M.V. Jali –PI

 

22.  

Reference Protocol no: CLR_13_14: Study Title: Pharmacodynamic efficacy and safety of Leuprolide depot 7.5 mg (SPIL) in subjects with Prostatic Adenocarcinoma.

ZYDUS

Dr. R.B. Nerli– PI

 

 

23.  

Protocol No: BBIL/JEV/IV/2012A: A Phase IV Single dose, Open labeled ,Comparative, Randomized Controlled study to evaluate the Immunogenicity and Safety of BBIL’s JENVAC(Inactivated JE vaccine)Vs. Chinese SA-14-14-2(Live JE vaccine )vaccine in healthy volunteers.

Bharat Biotech” – Company

Dr.N.S.Mahantshetti-PI

 

24.  

Protocol: Non drug clinical research on Evaluation of therapeutic efficacy of developed little millet products for management of diabetes.

Dr. M.V. Jali –PI

 

25.  

Protocol Title: “A Multicenter, Double-Blind,Vehicle Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% in the Treatment of subjects with Osteoarthritis of the Knee”.

 

26.  

Protocol I2R-MC-BIDB: A Comparison of LY2605541 versus Insulin Glargine as Basal Insulin Treatment in Combination with Oral Anti-Hyperglycemia Medications in Insulin –Naïve Patients with Type 2 Diabetes Mellitus: An Open-Label, Randomized, 52-week Study.

Dr. M.V. Jali –PI