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CTRI Number  CTRI/2018/01/011109 [Registered on: 02/01/2018] Trial Registered Prospectively
Last Modified On: 23/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate safety and efficacy of GRC 27864 in patients with hip / knee osteoarthritis pain 
Scientific Title of Study   A Phase 2, dose- range finding, 12-week, double-blind, randomized, parallel group study to evaluate safety and efficacy of GRC 27864 in patients with moderate osteoarthritis pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GRC 27864-201, Version No. 3.0, dated 31 Oct 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Pawan Singh 
Designation  Deputy General Manager - Clinical Development- Branded Generics 
Affiliation  Glenmark Pharmaceutical Ltd. 
Address  Glenmark House, Chakala, Andheri (E), Mumbai

Thane
MAHARASHTRA
400099
India 
Phone  912240189999  
Fax    
Email  Pawan.Singh@glenmarkpharma.com  
 
Details of Contact Person
Public Query
 
Name  Amol Pendse 
Designation  Deputy General Manager, Clinical Research Operations 
Affiliation  Glenmark Pharmaceutical Ltd. 
Address  Glenmark Research Centre, A-607, MIDC Mahape, Navi Mumbai

Thane
MAHARASHTRA
400709
India 
Phone  912267720000  
Fax    
Email  Amol.Pendse@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. Glenmark House, B.D. Sawant Marg, Chakala, Andheri (E), Mumbai, Maharashtra 400099 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals SA 
Address  Glenmark Pharmaceuticals S.A. Chemin de la Combeta 5 La Chaux-de-Fonds SWITZERLAND 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 48  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Kale  ACE Hospital  General OPD, Ground Floor, S.No-32/2A, Erandawane, Pune-411004
Pune
MAHARASHTRA 
9423585027

dramitkale@gmail.com 
Dr Sunil Maheshwari  Amena Khatun General Hospital  Opp. Sonal Cinema, Sarkhej Road, Ahmadabad-380055
Ahmadabad
GUJARAT 
09898983555

drsunilmaheshwari10@gmail.com 
Dr Maulik Patwa  Apollo Hospital International Limited  Plot 1 A, Bhat, GIDC Estate, Gandhinagar-382428,
Ahmadabad
GUJARAT 
07966701876

maulikpatwa@yahoo.com 
Dr A Navaladi  Apollo Hospitals  Orthopedic OPD, Ground Floor, Suit No. 130, #21, Greams Lane, Chennai–60000
Chennai
TAMIL NADU 
9840089932

navaladishankar@yahoo.co.in 
Dr Himanshu Panchal  B.J Medical college & Civil Hospital  Department of Orthopedic, Asarwa , Ahmedabad-380016
Ahmadabad
GUJARAT 
07922685938

drhimanshupanchal@gmail.com 
Dr Pramodini Shankaran  BhaktiVedanta Hospital and Research Institute  Room No. 4, Ground Floor OPD, Srishti Complex, Mira Road (East),Thane-401107
Thane
MAHARASHTRA 
9820317030

shankarankrishnan@yahoo.com 
Dr Reena Sharma  Care Institute Of Medical Sciences (CIMS) Hospital  Cabin No. 6, First Floor (East Wing), Off Science City Road, Sola, Ahmedabad – 380060
Ahmadabad
GUJARAT 
7940203148

reena141@gmail.com 
Dr Chandrashekara S  ChanRe Rheumatology & Immunology Center & Research  OPD 5, Ground Floor, No.414/65, Near Rajajinagar Metro Station, Bangalore-560010
Bangalore
KARNATAKA 
8042516699

chanrericr@yahoo.co.in 
Dr Aniket Shah  Chopda Medicare & Research Centre Pvt. Ltd  Ground Floor, OPD, Magnum Heart Institute, Canada Corner, Nashik-422005
Nashik
MAHARASHTRA 
9822910309

draniket@gmail.com 
Dr Milind Modak  Deenanath Mangeshkar Hospital & Research Centre   Department of Orthopedics, Erandwane, Pune-411008
Pune
MAHARASHTRA 
9371017638

drmilinddmodak@gmail.com 
Dr Karnav Panchal  Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre  Ratubhai Adani Arogyadham, Dr. Jivraj Mehta Marg, Ahmedabad-38007
Ahmadabad
GUJARAT 
9879010009

karnav1985@yahoo.com 
Dr Jacob Chako  Father Muller Medical College Hospital  Room no 7, Ground Floor, Department of Orthopedics, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA 
9845081423

chackojakes@gmail.com 
Dr Patel Jyotish Girishchandra  GCS Medical College, Hospital and Research Centre  Opp. DRM office, Nr. Chamuda Bridge, Naroda road Ahmedabad- 380025
Ahmadabad
GUJARAT 
9925037385

drjgpatel@gmail.com 
Dr Ramkrishna Rao Uppuluri  Gleneagles Global Hospitals  Room No 529, 1st Floor, 6-1-1070/1to4, Lakdikapool, Hyderabad-500004
Hyderabad
ANDHRA PRADESH 
9849160640

urkrao@yahoo.com 
Dr Somesh Singh  GMERS Medical College and Civil Hospital   Department Of Orthopedic, OPD No. 3, OPD Block A, S.G. Highway, Sola, Ahmedabad–380060
Ahmadabad
GUJARAT 
9825370446

drsomeshsingh@yahoo.com 
Dr Sajal Mitra  Government Medical College & Hospital  Room no 27, 1st Floor, Medical Square Road , Nagpur-440009
Nagpur
MAHARASHTRA 
9373114929

sajalmitra2007@yahoo.co.in 
Dr T Sudheer  Government Medical College and Government General Hospital  Research Wing, 2nd Floor, Beside FM Ward, Srikakulam-532001
Srikakulam
ANDHRA PRADESH 
9642725480

drtsudheer@gmail.com 
Dr Eknath Pawar  Grant medical college and Sir JJ hospital  OPD number 3, Ground Floor, Department of orthopaedics, Byculla, Mumbai-400008
Mumbai
MAHARASHTRA 
8551996777

Eknathpawar999@gmail.com 
Dr Surendra Kamath  Kasturba Medical College Hospital  Room no 12, Ground Floor, Attavar, Mangalore–575001
Dakshina Kannada
KARNATAKA 
9844275231

skamath3@manipal.edu 
Dr Vinod Kumar  KIMS Hospital  Department of Orthopedic, OPD Building, B block, K R Road, V V Puram, Bangalore-560004
Bangalore
KARNATAKA 
9886244455

dr.vinodac@gmail.com 
Dr Ashok Kumar  King George Hospital  Research Room, Medicine-New Block, Visakhapatnam-530002
Visakhapatnam
ANDHRA PRADESH 
9849123602

ashok_ortho59@rediffmail.com 
Dr Shailesh Udapudi  KLES Dr. Prabhakar Kore Hospital & Medical Research Centre  Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA 
91-9844032434

drsudapudi@gmail.com 
Dr Sunilkumar Singh  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Medical Research Department, 2nd Floor, Raosaheb Achutrao Patwardhan Marg, Four Bunglows, Andheri(W), Mumbai-400053
Mumbai
MAHARASHTRA 
9321542959

sunilkumar.r.singh@relianceada.com 
Dr Sarath Chandra Mouli Veeravalli  Krishna Institute of Medical Sciences (KIMS)  Room no 5363, 3rd Floor, Block 2, Rheumatology Department, 1-8-31/1, Minister road, Secunderabad-500003
Hyderabad
ANDHRA PRADESH 
9866000685

sarath10@hotmail.com 
Dr Nilesh Patil  Lifepoint Multispecialty Hospital  1st Floor, 145/1, Mumbai Bangalore Highway, Wakad, Pune-411057
Pune
MAHARASHTRA 
9673100066

njpatil@gmail.com 
Dr Arvind Goregaonkar  LTM Medical College & General Hospital  Room no 115, 1st Floor, Department of Orthopaedics , Sion, Mumbai–400022
Mumbai
MAHARASHTRA 
9821351787

abgortho@hotmail.com 
Dr Kunal Bhalla  M.V Hospital and Research Centre  Consultation Room 2, Ground Floor, 314/30,Mirza Mandi,Chowk,Lucknow-226003
Lucknow
UTTAR PRADESH 
0522-2258215

mvhrclko@gmail.com 
Dr Rajiv Gupta  Malpani Multispeciality Hospital  Ground Floor OPD, Department of Orthopedics, SP-6, Road no-1, Jaipur-302013
Jaipur
RAJASTHAN 
9414980697

drrajivg77@gmail.com 
Dr Manisha Daware  Mazumdar Shaw Medical Centre- A Unit of Narayana Health  258/A, Bommasandra Industrial area,Hosur Road,Anekal Taluk, Bangalore- 560099
Bangalore
KARNATAKA 
91-9538384433

daware.manisha@gmail.com 
Dr Girish Bhatia  Medipoint Hospital Pvt. Ltd.  Room Number 1, 1st Floor, 241/1,New DP Road, Aundh, Pune-411007
Pune
MAHARASHTRA 
7387003636

drbhatia.pentagon@gmail.com 
Dr Sushil Mankar  NKPSIM and Lata Mangeshkar Hospital Nagpur  1st Floor, Administrative Block, Orthopaedic Department, Digdoh Hills, Hingna Road, Nagpur-440019
Nagpur
MAHARASHTRA 
09422108284

drshmankar@gmail.com 
Dr Sachin Karkamkar  Noble Hospital Pvt. Ltd  Room no 20, Ground Floor, Ortho OPD, 153, Magarpattcity road, Hadapsar, Pune–411013
Pune
MAHARASHTRA 
9225505582

drsachinortho@yahoo.co.in 
Dr Ramchandra Kamath  Omega Hospital  Room no 11, B Block, Mahaveer Circle, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA 
9448452593

drkrk.epsilon@gmail.com 
Dr Anirudh Tembe  Oyster & Pearl Hospitals  Room No 504, 5th Floor, 671-75, Shivaji Nagar,Pune-411005
Pune
MAHARASHTRA 
02067216600

draniruddhatembe@gmail.com 
Dr Gaurav Rathi  Rathi Hospital  OPD 1, Ground Floor, Opposite Mahabalehwar Society, Ahmedabad-380015
Ahmadabad
GUJARAT 
9824015618

drgjrathi@yahoo.co.in 
Dr Sharad Purohit  Sanjivani Super Speciality Hospital Pvt. Ltd.  OPD No. 5, 1st Floor, 1 Uday Park Society, Vastrapur, Ahmedabad–380015
Ahmadabad
GUJARAT 
9879007908

dr_sharadpurohit@hotmail.com 
Dr Ravindra Wadhawan  Saviour Hospital  Saviour Multispecialty Hospital, Stadium Road, Navrangpura, Ahmadabad- 380014
Ahmadabad
GUJARAT 
917961908000

raviwadhawan2000@yahoo.com 
Dr Pratik Vinchhi  Shivam Hospital  C-4, Satyanarayan Society, Jasodanagar Char Rasta, Maninagar, Ahmedabad- 380008
Ahmadabad
GUJARAT 
9909032354

pratikdevanshzarana@gmail.com 
Dr Ashish Pongde  Shree hospital & Critical Care Centre  1st Floor OPD, 799, Om Nagar, Nagpur-440009
Nagpur
MAHARASHTRA 
9730310637

drpongade@gmail.com 
Dr Avinash Agarwal  Shri Nidaan Hospital & Hope Fertility Centre  Basement, OPD, 27-Vidhut Nagar-A, Jaipur-302021
Jaipur
RAJASTHAN 
9829058527

dravitrial@gmail.com 
Dr Rajiv Daveshwar  Sir Sayajirao General Hospital  Demonstration Room, 1st Floor, B2 ward, New surgical building, Jail road (Indira Avenue) Vadodara -390001
Vadodara
GUJARAT 
0265-2711275

dr_rndaveshwar@yahoo.com 
Dr G Narasimalu  St. Theresa Hospital  Room No. 1, Ground Floor, General Medicine Department, Sanathnagar, Hyderabad-500018
Hyderabad
ANDHRA PRADESH 
9441184683

narimuluhyderabad@gmail.com 
Dr Praveen Jadhav  Sujata Birla Hospital & Medical Research Center  OPD no 1, Ground Floor, Opposite Bytco College, Nasik Road, Nasik-422101
Nashik
MAHARASHTRA 
0253-2407700

praveenjadhav@rediffmail.com 
Dr Rupraj Pawar  Supe Heart & Diabetes Hospital & Research Centre  1st Floor OPD, Opposite Adharashram, Ashokstambh, Nasik-422002
Nashik
MAHARASHTRA 
0253-2232487

ruprajpawar@gmail.com 
Dr Sumit Agrawal  TULIP ONP Hospital  402/A, Gokhle Nagar, Vetal Baba Chowk, Off Senapati Bapat Road, Pune- 411016
Pune
MAHARASHTRA 
9822886661

Drsumitagrawal1111@gmail.com 
Dr Bankim Desai  Unique Hospital  Civil Hospital Char Rasta-Sosyo Circle Lane, off Ring Road, Surat-395002
Surat
GUJARAT 
91-9426645559

Drbankim.desai@gmail.com 
Dr Vrajesh Shah  Vadodara Institute For Reconstructive Orthopedic Care (VIROC Hospital)  Clinical Research Department, 3rd Floor, B-5 Nivruti Colony, Karelibaug, Vadodara-390018
Vadodara
GUJARAT 
0265-6541501

drvrs74@gmail.com 
Dr Krishna Subramaniyam Pannala  Yashoda Hospitals  Room no 4, OPD 1, Ground Floor, Nalgonda "X" Roads, Malakpet, Hyderabad-500036
Hyderabad
TELANGANA 
9246277646

subri_pannala@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 47  
Name of Committee  Approval Status 
Amena Khatun Hospital Ethics Committee  Approved 
BhaktiVedanta Hospital Ethics Committee  Approved 
Dhwani Ethics Committee, VIROC Hospital  Approved 
Ethics Commiittee, Unique Hospital-Multispeciality and Research Institute  Approved 
Ethics Committee, St. Theresa Hospital  Approved 
Ethics Committee-Care Institute Of Medical Sciences (CIMS)  Approved 
Father Muller Institutional Ethics Committee  Approved 
Instituitional Ethics Committee-Human Research, LTM Medical College  Approved 
Institutional Ethics Committee - YAMER  Approved 
Institutional Ethics Committee - AMAI Charitable Trust’s ACE Hospital  Approved 
Institutional Ethics Committee - ChanRe Rheumatology  Approved 
Institutional Ethics Committee - Clinical Studies  Approved 
Institutional Ethics Committee - Clinical Studies, Apollo Hospital  Approved 
Institutional Ethics Committee - Gleneagles Global Hospitals   Approved 
Institutional Ethics Committee - GMC, Nagpur  Approved 
Institutional Ethics Committee - GMERS Medical College  Approved 
Institutional Ethics Committee - Grant Medical College  Approved 
Institutional Ethics Committee - Malpani Multispeciality Hospital  Approved 
Institutional Ethics Committee for Human Research - Sir Sayajirao General Hospital  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Institutional Ethics Committee, KLE Academy of Higher Education and Research  Approved 
Institutional Ethics Committee, Kokilaben Dhirubhai Ambani Hospital  Approved 
Institutional Ethics Committee, MV Hospital  Approved 
Institutional Ethics Committee- Deenanath Mangeshkar Hospital and Research Centre  Approved 
Institutional Ethics Committee- Dr Jivraj Mehta Smarak Health Foundation Bakeri medical research center  Approved 
Institutional Ethics Committee- GCS Medical College  Approved 
Institutional Ethics Committee- Noble Hospital Pvt. Ltd  Approved 
Institutional Ethics Committee-Government Medical College and Government General Hospital  Approved 
Intuitional Ethics Committee-Kempegowda Institute of Medical Sciences, Bangalore  Approved 
KIMS Ethics Committee, Telangana  Approved 
Lifepoint Research Ethics Committee  Approved 
Magna Care Ethics Committee, Chopda Medicare  Approved 
MAHE Ethics Committee  Approved 
Narayana Health Medical Ethics Committee  Approved 
NKP Salve Institutional Ethics Committee  Approved 
O &P Institutional Ethics Committee  Approved 
O and P institutional Ethics Committee  Approved 
Omega Ethical Committee  Approved 
Pentamed Ethics Committee, Medipoint Hospital  Approved 
Rathi Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee   Approved 
Saviour Hospital Ethics Committee  Approved 
Shivam Ethics Committee  Approved 
Shree Hospital Ethics Committee  Approved 
Supe Hospital Ethics Committee  Approved 
Swastic Ethics Committee, Sri Nidan Hospital  Approved 
Yash Societys Sujata Birla Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GRC 27864  10 mg QD orally for 12 weeks 
Intervention  GRC 27864  25 mg QD orally for 12 weeks 
Intervention  GRC 27864  75 mg QD orally for 12 weeks 
Comparator Agent  Placebo  QD orally for 12 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male and female subjects aged 40 years to 70 years (both inclusive) at the time of signing the ICF

2. Subjects diagnosed with primary osteoarthritis of the hip or knee for at least 3 months in accordance with American College of Rheumatology (ACR) clinical and radiological criteria

3. Subjects who may or may not have received an NSAID or other oral analgesic therapy and report moderate pain intensity on 0-100 Visual Analogue Scale
 
 
ExclusionCriteria 
Details  1. Subjects experiencing severe pain, on 0-100 Visual Analogue Scale in most severely affected joint

2. Subjects who have history or presence of signs/symptoms suggestive active peptic ulcer disease and gastrointestinal (GI) bleeding

3. Subjects with known aspirin allergy, allergic reaction to non-steroidal anti-inflammatory drugs (NSAIDs) including asthma and urticaria

4. Use of NSAIDs, COX-2 inhibitors or aspirin (except aspirin up to 100 mg daily for cardio-protection) within previous 7 days of randomization

5. Use of oral, intra-articular or intramuscular corticosteroid or intra-articular hyaluronic acid within 12 weeks before randomization

6. Subjects with a history of myocardial infarction, coronary artery bypass grafting/ percutaneous coronary intervention, unstable angina, stroke or transient ischemic attack, congestive heart failure (CHF) with symptoms at rest or with minimal activity

7. Subjects with inherited or acquired disorders in platelet function, bleeding or coagulation or requiring anti-coagulation (except low dose aspirin for cardioprotection)

8. Presence of any clinically significant illness or disease; any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results

9. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at screening

10. Females who are pregnant or breastfeeding 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Mean change from baseline in the Western Ontario and McMaster’s University Osteoarthritis Index 3.1 pain subscale (WOMAC-PS) at the end of treatment  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change from baseline in the Patient Global Assessment of Response to Therapy (PGART) using 0-4 point Likert scale  2, 4, 8 and 12 weeks of treatment and at follow up (14 weeks) 
Mean change from baseline in the Investigator Global Assessment of Response to Therapy (IGART) using 0-4 point Likert scale  2, 4, 8 and 12 weeks of treatment and at follow up (14 weeks) 
Proportion of subjects meeting OMERACT-OARSI responder criteria  4 and 12 weeks 
Incidence of TEAEs and SAEs  Throughout study duration 
PK and PD assessment  Day 1 and Day 85 
Biomarker assessment  Day 85 
 
Target Sample Size   Total Sample Size="624"
Sample Size from India="624" 
Final Enrollment numbers achieved (Total)= "624"
Final Enrollment numbers achieved (India)="624" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/01/2018 
Date of Study Completion (India) 23/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a randomized, double-blind, parallel group, placebo-controlled study. A total of 624 (156 per arm) subjects will be enrolled in the study to receive GRC 27864 orally once daily doses of 10 mg, 25 mg, 75 mg and placebo for 12-weeks. The primary outcome measures will be the efficacy of GRC 27864 given orally at daily doses of 10 mg, 25 mg and 75 mg for 12-weeks compared to placebo assessed by WOMAC-PS in patients with moderate osteoarthritis pain. The secondary outcomes will be safety and tolerability of GRC 27864. Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality. 
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