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CTRI Number  CTRI/2014/05/004577 [Registered on: 01/05/2014] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Evaluate The Efficacy And Safety of Aceclofenac Topical Gel For The Treatment of Sprain and Muscle Pain 
Scientific Title of Study   A Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study To Evaluate The Efficacy And Safety of Aceclofenac Topical Gel 5% w/w Compare with HIFENAC GEL® 1.5% w/w For The Treatment of Sprain and Muscle Pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS/11/003, Version No. 03, Dated 02 MAY 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  #410 to 412, G- Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite

Ahmadabad
GUJARAT
380015
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  #410 to 412, G- Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite

Ahmadabad
GUJARAT
380015
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query  
Name  Mr Prasad Virkar 
Designation  Assistant Vice President 
Affiliation  Inventia Healthcare Private Limited 
Address  A-214, Road No. 30, Wagle Industrial Estate, Thane (West)

Thane
MAHARASHTRA
400604
India 
Phone  912267163681  
Fax    
Email  prasad.virkar@inventiahealthcare.com  
 
Source of Monetary or Material Support  
Inventia Healthcare Private Limited 
 
Primary Sponsor  
Name  Inventia Healthcare Private Limited 
Address  A-214, Road No. 30, Wagle Industrial Estate Thane (West) – 400 604, Maharashtra, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr H Lalnghakliana  Aizawl Civil Hoapital  Room No: 004, Ground Floor, Ortho OPD, Dawrpui
Aizawl
MIZORAM 		 09436143219

manghaka123@gmail.com 
Dr M K Yadav  CHC Government Hospital  CHC Government Hospital, Jakhania
Ghazipur
UTTAR PRADESH 		 09412365936

mkyadavskun@gmail.com 
Dr Ajay Gupta  Nirmal Hospital  Room no. G-3, Ground Floor, Orthopedics Center, Nirmal Hospital, Gate No. 3, Near MLB Medical College
Jhansi
UTTAR PRADESH 		 09005665599

ajaygupt70@yahoo.com 
Dr Bhavik Dalal  Smt Shardaben Chimanlal Lalbhai General Hospital  Room No. 9, Orthopedic OPD, Ground Floor, Smt Shardaben Chimanlal Lalbhai General Hospital, Saraspur
Ahmadabad
GUJARAT 		 09426357978

drbhavik2006@gmail.com 
Dr T S Raghavendra  Sri Siddhartha Medical College and Research Centre  Department-Orthopedic,Ground Floor, Sri Siddhartha Medical College and Research Centre, B.H. Road, Agalakote
Tumkur
KARNATAKA 		 09886252685

drkirants@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, Smt. NHL Municipal Medical College, Ahmedabad for Dr Bhavik Dalal   Approved 
Institutional Ethics Committee, Nirmal Hospital, Jhansi for Dr Ajay Gupta  Approved 
Institutional Review Board, Sri Siddhartha Medical College and Research Centre, Tumkur for Dr T S Raghavendra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aceclofenac Topical Gel 5% w/w   2 gm medication will be applied topically gently to cover the affected skin area twice daily for 7-14 days. 
Comparator Agent  HIFENAC Gel® 1.5% w/w  6.66 gm medication will be applied topically gently to cover the affected skin area twice daily for 7-14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex between 18-65 years of age.
2. Patients with painful sprain and/or muscle pain.
3. Patients with at least moderate pain of Visual Analogue Scale (VAS) greater or equal to 3.
4. Patient is able to provide written informed consent prior to study.
5. Willingness to comply with the study schedule and procedures. 
 
ExclusionCriteria 
Details  1. Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion.
2. Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
3. Patient with history of osteoarthritis / rheumatoid arthritis.
4. Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application.
5. Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study.
6. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
7. Patients with history of severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
8. Known hypersensitivity to aspirin, aceclofenac or any other ingredient of product.
9. Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
10. Participation in any other clinical trial during last 30 days. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Overall clinical response based on 50% relief in patient pain.
2. Pain intensity (Based on VAS). 		 7-14 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Physician’s Global Assessment Scale.
2. Need for rescue medication. 		 7-14 days 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2014 
Date of Study Completion (India) 02/03/2012 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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)?  

Response - NO
Brief Summary  

This is a Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study to evaluate the efficacy and safety of Aceclofenac Topical Gel 5% w/w compare with HIFENAC GEL® 1.5% w/w for the treatment of Sprain and Muscle Pain. Eligible patients randomised based on 1:1 ratio will be applied test or reference product topically gently to cover the affected skin area twice daily for 7 days. If efficacy is not confirmed on day 7, treatment will be extended for non-responders for up to 14 days. Overall clinical response based on 50 % relief in sign and symptoms, pain intensity based on VAS and Physician’s Global Assessment Scale will be evaluated at the end of study visit and at follow-up visit as compared to baseline. Safety will be evaluated based on measurements of laboratory investigations of SGOT, SGPT, Serum Creatinine and Urea at the end of the study visit and by reporting of any adverse events.

 
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