| CTRI Number |
CTRI/2026/04/109113 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/06/2026 |
| 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 study to test a Diclofenac Gel in comparison with another reference gel and an inert gel for Pain Relief and Safety in Fresh Outer Ankle Sprains (ankle twists) |
|
Scientific Title of Study
|
A bioequivalence, multi center, double blind, randomized, placebo controlled, parallel group study, comparing Diclofenac diethylamine gel, 2.32 percentage (JAMP Pharma Corporation, Canada) to Voltaren Emulgel Extra Strength Extra Fort (Diclofenac diethylamine 2.32 percentage weight by weight) (GlaxoSmithKline Consumer Healthcare ULC, Mississauga, ON L5R 4B2(Canadian Reference Product) and both active treatments to a placebo control in the treatment of acute sprain of lateral ankle. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Peeyush Chansouria |
| Designation |
MBBS, MS (ortho) |
| Affiliation |
Swami Harshankaranand Ji Hospital & Research Centre |
| Address |
Swami Harshankaranand Ji Hospital & Research Centre, N 8/237 Newada,Bhu,Sunderpur,Varanasi-221005,Uttarpradesh,India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9336912471 |
| Fax |
05422367758 |
| Email |
sudbhawanacrvns@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channabasavanna G Halasagi |
| Designation |
Medical Monitor |
| Affiliation |
Invitro Research Solutions Pvt Ltd |
| Address |
Clinical Development Department,Medical Monitoring Divison,Room No 302,3rd Floor, No 22 & 23,Kodigehalli Main Road,Sahakar Nagar Post,Hebbal,Bangalore,KARNATAKA
560092,India
Bangalore
KARNATAKA
560092
India |
| Phone |
6366947473 |
| Fax |
|
| Email |
channa@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
T Vijaya Bhaskar |
| Designation |
Senior Director- Clinical Development |
| Affiliation |
Invitro Research Solutions Pvt Ltd |
| Address |
Clinical Development
Department, Clinical Operations Division,1st Floor, No 22 & 23,Kodigehalli Main Road,Sahakar Nagar Post,Hebbal,Bangalore,KARNATAKA
560092,India
Bangalore
KARNATAKA
560092
India |
| Phone |
6366575282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| SPONSOR- JAMP Pharma Corporation 1310 Nobel Street, Boucherville, Quebec, J4B 5H3, Canada |
|
|
Primary Sponsor
|
| Name |
JAMP Pharma Corporation |
| Address |
JAMP Pharma Corporation 1310 Nobel Street, Boucherville, Quebec, J4B 5H3, Canada |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod Kumar A C |
Kempegowda Institute of Medical Sciences |
Room 10,Super speciality OPD,Dept of Endocrinology,1st Floor,Outpatient block,Kempegowda
Institute of Medical Sciences-Clinical Research Department,K R Road,V V Puram,Bangalore-560004
Bangalore
KARNATAKA |
9886244455
9886244455
vinodabbur@gmail.com |
| Dr M Javed Iqbal M Jaleel |
Lifepoint Multispecialty Hospital |
3rd Floor,Room No.1,Research Department,Lifepoint Multispecialty Hospital,Sr.No.145/1,Mumbai Banglore Highway,Near Hotel Sayaji, Wakad, Pune-411057,Maharashtra
Pune
MAHARASHTRA |
8308081314
020-66434399
drjavedjaleel1@gmail.com |
| Dr Patil Sameer Sanjeev |
Medipoint Hospitals Pvt Ltd |
241/1, New D.P.Road, Aundh, Pune-411007
Pune
MAHARASHTRA |
8600883303
8600883303
drsameerpatil01.medipoint@gmail.com |
| Dr Arun G R |
Mysore Medical College and Research Institute |
Department of Orthopaedics, Mysuru P.K.T.B and C.D. Hospital campus, K.R.S. Road, Mysuru-570001
Mysore
KARNATAKA |
9003343337
9003343337
drgrarun@gmail.com |
| Dr Peeyush Chansouria |
Swami Harshankaranand Ji Hospital & Research Center |
2nd Floor Room No.213,Department of Clinical Research,N8/237,BHU-DLW Rd,Sunderpur,Newada,Varanasi, Uttar Pradesh-221005
Varanasi
UTTAR PRADESH |
9336912471
9336912471
sudbhawanacrvns@gmail.com |
| Dr Sharath Kumar P V |
Victoria Hospital |
Bangalore Medical College & Research Institute, Fort, K R Road, Bangalore-560002
Bangalore
KARNATAKA |
9964077479
9964077479
drsharathpv@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee of BMCRI |
Approved |
| Kempegowda Institute of Medical Sciences Institutional Ethics Committee |
Approved |
| Lifepoint Research- Ethics Committee |
Approved |
| Mysore Medical College & Research Institute and Associated Hospitals Institutional Ethics Committee |
Approved |
| Penta-Med Ethics Committee |
Approved |
| Swami Harshankaranand Ji Hospital & Research Centre Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S934||Sprain of ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (P): Vehicle gel |
The participants will be
instructed to apply
approximately 4 grams
(approximately 4.5-inch length
of gel) of assigned study
treatment topically on to the
affected site for 2 times a day
throughout the study duration
of 7 days. Dose to be applied will be measured using dosing card. |
| Comparator Agent |
Reference Product (R): Voltaren Emulgel Extra Strength/Extra Fort (Diclofenac diethylamine 2.32% w/w) |
The participants will be
instructed to apply
approximately 4 grams
(approximately 4.5-inch length
of gel) of assigned study
treatment topically on to the
affected site for 2 times a day
throughout the study duration
of 7 days. Dose to be applied will be measured using dosing card. |
| Intervention |
Test product (T): Diclofenac diethylamine 2.32% w/w gel |
The participants will be
instructed to apply
approximately 4 grams
(approximately 4.5-inch length
of gel) of assigned study
treatment topically on to the
affected site for 2 times a day
throughout the study duration
of 7 days. Dose to be applied will be measured using dosing card. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or Female participant, greater than or equal to 18 years and Less than or equal to 65 years of age at the time of enrolment.
2.Diagnosed by physical examination with acute sprain of lateral ankle, Grade I and II (as classified by The West Point Ankle Grading System).
3.Injury leading to sprain must have occurred within 24 hours prior to enrolment.
4.Pain on movement of injured area [measured on a 100 mm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain)] greater than or equal to 50 mm immediately prior to randomization.
Note: Pain on movement on a Visual Analogue Scale (VAS) will be registered by the participant lying down while the investigator holds the injured leg at 45° and performs gentle supination of the injured ankle to reach an angle of approx. 30°.
5.Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits.
6.Willingness to avoid use of other topical or systemic analgesic or anti-inflammatory medications during the study period, except permitted rescue medication (Paracetamol 650 mg, or other Investigator-approved rescue medication).
7.Willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
8.Female subjects of childbearing potential must:
Have a negative urine pregnancy test at screening and agree to use acceptable contraception during the study. |
|
| ExclusionCriteria |
| Details |
1.Severe (Grade III) ankle sprain, complete ligament rupture, ankle dislocation, or suspected or confirmed fracture (based on clinical assessment or imaging, if performed) not considered amenable to treatment with topical NSAIDs alone.
2.Open skin lesion in the injured area.
3.Dermatological conditions, such as eczema or skin infections on the injured area.
4.Use of medication (other than the study drugs) for the treatment of complaints caused by the affected area.
5.Other inflammatory or painful conditions (e.g. headache, toothache).
6.Similar injury of the same area within the last 3 months.
7.Debilitating acute or chronic illness.
8.Use of long-acting NSAIDs, cyclooxygenase (COX)-2 inhibitors or tramadol in the previous 24 h; any other analgesics in the previous 6 h; use of any other topical products applied to the target site (Treatment by rest, ice, compression, or elevation prior to randomization is allowed).
9.Use of Systemic corticosteroid or immunosuppressive drugs in the previous 8 weeks.
10.Pregnant or lactating or planning to become pregnant during the study period.
11.Participants with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory agents.
12.History of Osteoarthritis, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
13.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
14.History of gastrointestinal bleeding or peptic ulcer disease.
15.Known allergy to aspirin or other Nonsteroidal Anti-Inflammatory Drug (NSAID), Known hypersensitivity or allergy to Diclofenac diethylamine (investigational product) and excipients of the formulation.
16.Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past month prior to entry into the study.
17.Women of child-bearing age who are not surgically incapable of pregnancy and are unwilling to use an acceptable method of birth control.
18.Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s).
19.Unwillingness or inability to comply with the clinical trial procedures.
20.Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons.
21.Participants who are deemed to be legally incapacitated.
22.Participants who are legally detained in an official Institute. |
|
|
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 |
| To confirm the equivalence of clinical efficacy and tolerability of the generic Diclofenac diethylamine 2.32% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel (Reference) in patients with acute sprain of lateral ankle as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0-100) after seven days of treatment |
From Baseline Day 1 to Day 5 (End of Treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in daily VAS pain on rest score at morning and at night from baseline to Day 7. Mean change in VAS of pain on movement of injured area from baseline to Day 3 and Baseline to Day 8. Proportion of participants with reduction in VAS of pain on movement of injured area from baseline to Day 3, Day 5 and Day 8. Mean change of normal function/activity of the injured area from baseline Day 1 to Day 3, Day 5 and Day 8.Proportion of participants with improvement in normal function/activity of the injured area on Day 3 compared to baseline Day 1, Day 5 compared to baseline Day 1 and Day 8 compared to baseline Day 1. Proportion of participants with improvement in passive joint mobility on Day 3 compared to baseline Day 1,Day 5 compared to baseline Day 1 and Day 8 compared to baseline Day 1 |
From Baseline Day 1 to Day 3,Baseline Day 1 to Day 5,Baseline Day 1 to Day 8 |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "360"
Final Enrollment numbers achieved (India)="360" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/05/2026 |
| Date of Study Completion (India) |
25/08/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is Randomized, Double blind, Placebo controlled Clinical trial for comparing the Efficacy and Tolerability of Diclofenac diethylamine 2.32% w/w gel of JAMP Pharma vs Voltaren Emulgel® (Diclofenac diethylamine 2.32% w/w) of GlaxoSmithKline Consumer Healthcare ULC.,Mississauga, ON L5R 4B2 in Patients with Acute Sprain of Lateral Ankles. Sample size is 360: 120 Participants for Test, 120 for Reference and 120 for Placebo, where the primary objective is to confirm the safety of generic Diclofenac diethylamine 2.32% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel Extra Strength/Extra Fort (Reference) in patients with with Acute Sprain of Lateral Ankles on relief of pain as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0 to 100) after seven days of treatment and secondary objective is to confirm the superiority of Test and Reference to Placebo in pain after seven days of treatment, to estimate the relief of pain of Test product compared to Reference during the treatment period and to demonstrate the tolerability of Test and Reference products. |