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CTRI Number  CTRI/2010/091/003050 [Registered on: 13/12/2010]
Last Modified On: 18/04/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 To determine the efficacy and safety of diclofenac topical solution in comparison with topical diclofenac gel in acute painful musculoskeletal conditions. 
Scientific Title of Study
Modification(s)  		 A randomized, two arm, open label, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical solution of diclofenac (4.64% w/v) in comparison with diclofenac topical gel (1.16% w/w) in acute painful musculoskeletal conditions. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CT/06/03  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Sanjay Maroo 
Designation   
Affiliation   
Address  Troikaa Pharmaceuticals Ltd.
Commerce House-1 Opp Rajvansh Tower Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India 
Phone  079-26856242  
Fax  079-26856246  
Email  medicalservices@troikaapharma.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Sanjay Maroo 
Designation   
Affiliation  GM-Medical Services Dept. 
Address  Troikaa Pharmaceuticals Ltd.
Commerce House-1 Opp Rajvansh Tower Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India 
Phone  079-26856242  
Fax  079-26856246  
Email  medicalservices@troikaapharma.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Sanjay Maroo 
Designation   
Affiliation  GM-Medical Services Dept. 
Address  Troikaa Pharmaceuticals Ltd.
Commerce House-1 Opp Rajvansh Tower Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India 
Phone  079-26856242  
Fax  079-26856246  
Email  medicalservices@troikaapharma.com  
 
Source of Monetary or Material Support
Modification(s)  
Troikaa Pharmaceuticals Ltd., Commerce House-1, Opp Rajvansh Tower Off. Judges Bunglows, Ahmedabad 380054. 
 
Primary Sponsor
Modification(s)  
Name  Troikaa Pharmaceuticals Ltd 
Address  Commerce House-1 Opp Rajvansh Tower Off. Judges Bunglows Ahmedabad 380054. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Nil   
 
Countries of Recruitment
Modification(s)  		   India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. S. Ramanathan  Bone & Joint Clinic  57,Arapalayam Cross Road,-625016
Madurai
TAMIL NADU 		 +91-9750626216

ramms_mdu@yahoo.co.in 
Dr Vasant Panchal  Panchal Pain Clinic  Panchal Pain Clinic 223 National Plaza Opposite Ayurved College Near Railway Station Surat.
Surat
GUJARAT 		 09228492620

panchalpainclinic@gmail.com 
Dr CV Pradhan  Sancheti Institute for Orthopaedics and Rehabilitation  16 Shivajinagar Pune 411005.
Pune
MAHARASHTRA 		 09823030657

pradhanchetan@hotmail.com 
Dr Ateet B Sharma  Satellite Orthopaedic Hospital And Research Centre Pvt. Ltd.  302 Vraj Complex Opp Dhananjay Tower 100ft Ring Road Satellite Nr Shyamal Cross Roads Ahmedabad 380015
Ahmadabad
GUJARAT 		 09824061766

ateetsharma72@rediffmail.com 
Dr. Jayantilal Talesara  Talesara Hospital  Plot No. 6, S. No. 6/A/1, Next to ganga complex,Behind sai baba mandir, Airport Road, Yerwada-411006
Pune
MAHARASHTRA 		 +91-9822502571

drjmtalesara@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Independent Ethics Committee  Approved 
Independent Ethics Committee  Approved 
Independent Ethics Committee Aditya  Approved 
Independent Ethics Committee - Aditya  Approved 
Sancheti Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  In acute painful musculoskeletal conditions,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Diclofenac Gel  4 times a day for 7 days 
Intervention  Diclofenac topical solution  4 times a day for 7 days 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male or females patients aged 18- 70 years.
2.Patients with acute low back ache (non- specific) or pain and inflammation following trauma to muscles/ tendons/ ligaments/ joints (due to strains, sprains, stress, soft tissue injuries or blunt sports injuries) for not more than 2 days
3.Patients with at least moderate pain of VAS ≥ 4 
 
ExclusionCriteria 
Details  1.Patients below 18 years or above 70 years of age.
2.Hypersensitivity to aspirin/ NSAID or any other component of the formulation
3.Any contraindication to diclofenac / NSAIDs
4.Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application
5.Concomitant skin disease at site of application
6.Use of another topical product at application site
7.Pregnant women and lactating mothers
8.Women of child bearing age not practicing or not willing to use contraceptive
9. Patients already on oral NSAIDs/ analgesics
10. Patients requiring hospitalization or other treatment for pain 
 
Method of Generating Random Sequence
Modification(s)  		 Computer generated randomization 
Method of Concealment
Modification(s)  		 An Open list of random numbers 
Blinding/Masking
Modification(s)  		 Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
50% pain reduction at 7 days.  End of the study visit 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Need for rescue analgesia  During entire study period 
Degree of local signs (Swelling, Tenderness)  End of study visit 
Degree of functional impairment  End of study visit 
Patients & Physicians global assessment  End of study visit 
Pain intensity at rest and passive movement  On day 3 and End of study visit 
 
Target Sample Size
Modification(s)  		 Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 Phase 3 
Date of First Enrollment (India)
Modification(s)  		 20/03/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  20/03/2011 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="8"
Days="13" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Results of the study is published in international journal of research in medicine, same is available at below link; http://www.ijorim.com/siteadmin/article_issue/137587850823%20troika%20110-15.pdf 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This study is a randomized, two arm, open label, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical solution of diclofenac (4.64% w/v) in comparison with diclofenac topical gel (1.16% w/w) in acute painful musculoskeletal conditions in total 250 patients at multiple sites in india. Patients are randomized to receive either topical diclofenac solution or diclofenac gel. The primary outcomes will be on set of analgesia,50% pain reduction at 7 days and Improvement in pain intensity as determined by VAS. The secondary out comes will be Need for rescue analgesia, Pain intensity at rest and passive movement,Degree of local signs (Swelling, Tenderness),Degree of functional impairment and Patients & Physicians global assessment. 
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