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CTRI Number  CTRI/2015/02/005510 [Registered on: 09/02/2015] Trial Registered Prospectively
Last Modified On: 29/08/2017
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 clinical trial to study the effects of two drugs, Dynapar QPS and placebo topical solution in patient suffering from osteoarthritis. 
Scientific Title of Study   A prospective, randomized, double blind, two arm, parallel, placebo controlled, comparative, multicentre clinical study to evaluate the safety and efficacy of Dynapar QPS compared to placebo topical solution for treatment of osteoarthritis of knee 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT/06/02/13, Version 01, Date:01/05/2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Amarinder Singh 
Designation  GM-Medical Services 
Affiliation  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  9099905926  
Fax  07926856246  
Email  amarindersingh@troikaapharma.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Agam Shah 
Designation  DGM, Medical Services 
Affiliation  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  07926856242  
Fax  07926856246  
Email  agamshah@troikaapharma.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Agam Shah 
Designation  DGM, Medical Services 
Affiliation  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  07926856242  
Fax  07926856246  
Email  agamshah@troikaapharma.com  
 
Source of Monetary or Material Support  
Troikaa Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Troikaa Pharmaceuticals Limited  
Address  Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad 380054, Gujarat, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ranadeep Rudra  Apollo Gleneagles Hospitals  Department of rheumatology, Apollo Gleneagles Hospitals, 58 canal circular road, kolkata 700054
Kolkata
WEST BENGAL 		 9831575497

rudra_ortho@hotmail.com 
Dr A Navaladi Shankar  Apollo Hospitals Educational and Research Foundation  Department of orthopaedics, Apollo Hospital, 21, Greams Lane, Off. Greams Road, Chennai, Tamilnadu 600006
Chennai
TAMIL NADU 		 9840089932

navaladishankar@yahoo.co.in 
Dr Shuvendu Prosad Roy  Fortis Flt. Lt. Rajan Dhall Hospital, Delhi  Orthopaedics, Joint Replcement & Spine Surgery, Fortis Flt. Ltd., Rajan Dhal Hospital, Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasantkunj, New Delhi - 110070
New Delhi
DELHI 		 09911477748

roysp27973@gmail.com 
Dr Arvind Chopra  Inamdar Mutlispeciality Hospital  Hospital Building, Sr. No. 15, Fatima Nagar, Pune - 411040 Maharashtra, India.
Pune
MAHARASHTRA 		 02026344099

arvindchopra60@hotmail.com 
Dr Vishwanath Yaligod  Sapthagiri Institute of Medical Sciences and Research Center  Department of orthopaedics,Sapthagiri Institute of Medical Sciences and Research Center, #15.Chikkasandra.Hesaraghatta Main Road, Bangalore-560 090
Bangalore
KARNATAKA 		 08028393392

vvyaligod@gmail.com 
Dr S K Srivastava  Seth GS Medical College & KEM Hospital   Dept of Orthopaedic, K.E.M Hospital & Seth G.S Medical College , Mumbai-400012
Mumbai
MAHARASHTRA 		 9819710059

sudhirkumarsrivastava@hotmail.com 
Dr Dhaval R Modi  Sheth VS general Hospital  Department of Orthopaedics, V.S. General Hospital, Near Town Hall, Ellisbridge, Ahmedabad-380 006
Ahmadabad
GUJARAT 		 9925014537

drdrmodi@hotmail.com 
Dr Joe Joseph Cherian  St.Johns Medical College Hospital  Dept. of orthopaedics, st. johns medical college hospital, sarjapur road, koramangala, bangalore – 560034
Bangalore
KARNATAKA 		 9731214915

mathewdavid20@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Ethics Committee for Research Fortis Flt. Rajan Dhall Hosptial  Approved 
Ethics Committee Sheths V.S. Medical Research Foundation Trust  Approved 
Ethics Committee, Apollo Hospital  Approved 
Ethics Committee, Inamdar Multispeciality Hospital  Approved 
Institutional Ethics Committee, Apollo Gleneagles Hospital  Approved 
Institutional Ethics Committee, Sapthagiri Institute Of Medical Sciences and Research Center  Approved 
Institutional Ethics Committee, Seth GS Medical College and KEM Hospital  Approved 
St John’s Medical College & Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dynapar QPS (Diclofenac diethylamine 4.64% w/v topical solution)  5 sprays QID for 6 weeks Each pump spray (0.1 ml) will deliver 4.64 mg of diclofenac diethylamine, equivalent to 4 mg of diclofenac sodium.  
Comparator Agent  Placebo topical solution   5 sprays QID for 6 weeks Each pump spray deliver 0.1 ml of placebo topical solution  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of either gender, 40-65 years of age
2.Patient fulfilling modified American College of Rheumatology (ACR) criteria for osteoarthritis of knee
3.Patients on frequent oral analgesic treatment (at least 3 days per week during the previous 4 weeks) for at least past 4 weeks for the management of symptomatic unilateral or bilateral primary osteoarthritis of knee at the time of screening
4.Patients with at least moderate intensity of pain (defined as score of greater than or equal to 4 on 10 point visual analogue scale) while performing a weight-bearing activity e.g. walking, standing, climbing stairs during or at the end of washout period after screening
 
 
ExclusionCriteria 
Details  1.History of major trauma or surgery in the study joint within previous 6 months at the time of screening
2.History of acute inflammatory arthritis, pseudogout or crystal deposition disorder of the study knee joint
3.Radiographic evidence suggestive of arthritis other than primary osteoarthritis
4.Patients receiving prescription muscle relaxants, psychotropic agents (except tramadol) corticosteroids or any other drug affecting the evaluation of analgesic action; or taking supplements like glucosamine and chondroitin sulfate.
5.Patients with alternative form of therapy i.e. physical manipulation, acupuncture etc.
6.Intramuscular corticosteroids in past 4 weeks or; oral or topical corticosteroids in past 2 weeks at the time of screening
7.Intra-articular injection of any drug within past 4 weeks at the time of screening
8.Patients with history of cardiovascular surgery i.e., coronary artery bypass graft or Percutaneous coronary intervention, within past 4 weeks at the time of screening
9.Patients who require or scheduled for any surgery (including knee joint surgery) during study period
10.Uncontrolled systemic disorders like diabetes mellitus, hypertension, or cardiac disorder requiring hospitalization
11.Renal or hepatic impairment as per following laboratory parameters,
•Serum creatinine greater than upper limit of normal;
•SGOT or SGPT greater than 3 times upper limit of normal
12.Patients requiring hospitalization during the study period
13.Skin disorder at the site of study drug application
14.Use of other topical medicines at the same site of study drug application
15.Known case of gastrointestinal bleeding or peptic ulcer disease
16.History of bronchial asthma, bronchitis or any other contraindication to study drugs
17.Known hypersensitivity to NSAIDs or history of hypersensitivity to any topical medication
18.Patients on any form of anticoagulation therapy
19.Pregnant and lactating women
20.Women of child bearing potential, not practicing or not willing to use contraceptive method during study period unless patient had undergone hysterectomy
21.Patient unwilling or incapable of giving informed consent or to comply with study procedures
22.Patients having participated in any clinical trial within last 30 days at the time of screening
23.Previous participation in this study
24.Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Change from baseline in WOMAC index sub score for pain
• Change from baseline in VAS Score for pain intensity on weight bearing activity

 		 Day 1, 7, 14, 28 and 42 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in the WOMAC index sub scores other than pain e.g. stiffness and physical function  Day 1, 7, 14, 28 and 42 
Mean number of tablets of rescue analgesic required during the study period  Day 1 to 42 
Mean number of days for which patient required rescue analgesic during the study period  Day 1 to 42 
Proportion of patients requiring rescue analgesia for greater than or equal to 50% (greater than or equal to 21 days) of study period   Day 1 to 42 
Global assessment of efficacy by patients and investigator  Day 42 
Change in vitals  Day 1, 7, 14, 28 and 42 
Change in adverse events with pre-enrollment systemic analgesic therapy after initiation of study medication  Day 1 
Local adverse events   Day 1 to 42 
Systemic adverse events   Day 1 to 42 
Clinical laboratory parameter abnormality  During screening and on day 42 
Global assessment of tolerability by patients and investigator  Day 42 
 
Target Sample Size   Total Sample Size="212"
Sample Size from India="212" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/02/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Results of the trials will be published after completion of the trial 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is a prospective, randomized, double blind, two arm, parallel, placebo controlled, comparative, multicentre clinical study to evaluate the safety and efficacy of Dynapar QPS (5 sprays, QID) compared to placebo (5 sprays, QID) topical solution in 212 patients with osteoarthritis of knee, that will be conducted in 8 centers in India. The primary outcome measures will be Change from baseline in WOMAC index sub score for pain on week 1, 2, 4 and 6. Change from baseline in VAS Score for pain intensity on weight bearing activity will also be assessed on week 1, 2, 4 and 6. The secondary outcome measured will be Change from baseline in the WOMAC index sub scores other than pain e.g. stiffness and   physical function on week 1, 2, 4 and 6. Mean number of tablets of rescue analgesic required during the study period on week 1, 2, 4 and 6. Mean number of days for which patient required rescue analgesic during the study period on week 1, 2, 4 and 6. Proportion of patients requiring rescue analgesia for ≥ 50% (≥ 21 days) of study period. The Global assessment of efficacy by patients and investigator will be done at week 6.

 
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