| CTRI Number |
CTRI/2013/06/003751 [Registered on: 14/06/2013] 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 Safety and Efficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol In Painful Musculoskeletal Conditions. |
|
Scientific Title of Study
|
A Multi-center, Prospective, Open-label, Randomized, Active-Controlled, Parallel-Group Clinical Study of Safety and Efficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol With Voveran® Thermagel™ (Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol) In Painful Musculoskeletal Conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECTS/13/002, Version No. 00, Dated 30 MAR 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 |
5/C, Vardan Tower, Nr. Vimal House, Vithalbhai Patel Colony, Navrangpura
Ahmadabad
GUJARAT
380014
India |
| Phone |
9825585119 |
| 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 |
5/C, Vardan Tower, Nr. Vimal House, Vithalbhai Patel Colony, Navrangpura
Ahmadabad
GUJARAT
380014
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gour Mukherji |
| Designation |
Senior Vice President – Formulation and Analytical R & D |
| Affiliation |
Inventia Healthcare Private Limited |
| Address |
A-214, Road No. 30, Wagle Industrial Estate, Thane (West)
Thane
MAHARASHTRA
400604
India |
| Phone |
2267163466 |
| Fax |
|
| Email |
gour.mukherji@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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Darshan Shah |
Divyadarshan Orthopedic Hospital |
Hiral Complex, Bhattha Char Rasta,
Paldi, Ahmedabad-380007, Gujarat, India
Ahmadabad
GUJARAT |
09825018004
divyadarshan22@yahoo.com |
| Dr Mahesh L Shukla |
Dr. Shukla’s Hospital |
Behind Alankar Cinema, M. G. Road,
Bardoli-394602 Dist. Surat, Gujarat, India
Surat
GUJARAT |
09825120547
drshukla99@yahoo.co.in |
| Dr Ronak Shah |
Poojan Multispeciality Hospital |
1st Floor, Navnidhi Avenue, Gurukul Road,Subhash Chowk, Memnagar, Ahmedabad-380052, Gujarat, India
Ahmadabad
GUJARAT |
09898783040
poojan.research@gmail.com |
| Dr Mayank Thakker |
Shree Giriraj Multispeciality Hospital |
150 Feet Ring Ring Road, 27-Navjyot Park Main Road, Rajkot-360004
Rajkot
GUJARAT |
0909971118
drmayankthakker@shreegirirajhospital.com |
| Dr Anoop Khandelwal |
Shubh Hospital |
Opp. Shobhna Nagar, Near Palm View Appt.,
Vasna Road, Vadodara- 390007, Gujarat, India
Vadodara
GUJARAT |
09727767712
khandelwal.anoop@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Shree Giriraj Hospital Research Ethics Committee, for Dr Mayank Thakker |
Approved |
| Spandan Independent Ethics COmmittee, Ahmedabad for Dr Anoop Khandelwal |
Approved |
| Spandan Independent Ethics Committee, Ahmedabad for Dr Darshan Shah |
Approved |
| Spandan Independent Ethics Committee, Ahmedabad for Dr Mahesh Shukla |
Approved |
| Spandan Independent Ethics Committee, Ahmedabad for Dr Ronak Shah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol |
2-4 fingertip units (according to calibrator given to patients, providing 20-40 mg of diclofenac) should be applied to the affected area three to four times daily for 7 days |
| Comparator Agent |
Voveran® Thermagel™ |
2-4 fingertip units (according to calibrator given to patients, providing 20-40 mg of diclofenac) should be applied to the affected area three to four times daily for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients aged 18 – 65 years (both inclusive).
2.Patients with mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures like sprains, strains, as well as tendinitis, bursitis, neck & shoulder pain, sciatica, muscle stiffness, joint pain and lumbago.
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 painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
2.Patients with known history of severe osteoarthritis and rheumatoid arthritis.
3.Patients with active or recent history of inflammatory diseases of the gastrointestinal tract such as peptic ulcer, gastritis, regional enteritis, or ulcerative colitis.
4.History of aspirin-sensitive asthma, adverse reaction to oral nonsteroidal anti-inflammatory drug (NSAID), bleeding diathesis, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease or in the setting of coronary artery bypass graft surgery (CABGS).
5.Patients with uncontrolled hypertension(Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
6.Patients with open wounds infected skin or other conditions of broken skin, skin affected by infection, inflammations at the site of proposed application.
7.Patients underlying dermatitis or dermatosis associated with the injury.
8.Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study, or any other topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetics.
9.Known hypersensitivity to aspirin, diclofenac diethylamine or any other ingredient of product.
10.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the patient at risk by participating in the study.
11.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.
12.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 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Physician’s Global Assessment Scale.
2.Need for rescue medication (acetaminophen). |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2013 |
| Date of Study Completion (India) |
10/08/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
A Multi-center, Prospective, Open-label,
Randomized, Active-Controlled, Parallel-Group Clinical Study of Safety and
Efficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and
Menthol In Painful Musculoskeletal Conditions. Eligible patients will be randomised based on 1:1 ratio of test and reference product 2-4 fingertip units (providing 20-40 mg of
diclofenac) should be applied to the affected area three to four times daily for 7 Days. During treatment period also assess the VAS and Physician’s Global
Assessment Scale. Safety evaluated based on measurements of laboratory investigations of
SGOT, SGPT, serum creatinine and urea at the end of the study visit and
reporting of any adverse events. |