| CTRI Number |
CTRI/2023/01/049202 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the efficacy and tolerability of diclofenac diethylamine 1.16% w/w gel in patients with acute localised muscle or joint injuries |
|
Scientific Title of Study
|
Non-inferiority, Randomized, Double- blind Clinical Trial for Comparing the Efficacy and
Tolerability of Diclofenac diethylamine 1.16% w/w gel of JAMP Pharma vs Voltaren
Emulgel® (Diclofenac diethylamine 1.16% w/w) of GlaxoSmithKline Consumer Healthcare
Inc., Canada in Patients with acute localized muscle or joint injuries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| iVRS-CD-22-037 Version 01 Dated 18 Oct 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hrishikesh Patkar |
| Designation |
MBBS DNB(ortho) |
| Affiliation |
Lifepoint Multispeciality Hospital |
| Address |
Lifepoint Multispecialty hospital,
145/1, Mumbai Bangalore highway,
near hotel Sayaji, Wakad ,
pune-411057, Maharashtra, India.
Orthopaedics, 3rd floor, OPD no: 01
Pune
MAHARASHTRA
411057
India |
| Phone |
9730475068 |
| Fax |
|
| Email |
patkarhrishikesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channa Basavanna G Halasagi |
| Designation |
Medical Monitor |
| Affiliation |
In Vitro Research Solutions Pvt. Ltd. |
| Address |
Invitro Research Solutions Pvt. Ltd, Clinical Development
Department, Medical Monitoring Divison, Room No 301, 3rd Floor
No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
6366947473 |
| Fax |
|
| Email |
channa@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
T Vijay Bhaskar |
| Designation |
Director- Clinical Development |
| Affiliation |
In Vitro Research Solutions Pvt. Ltd. |
| Address |
Invitro Research Solutions Pvt. Ltd, Clinical Development
Department, Clinical Operations Divison, 2nd Floor No.
22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
636675282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| JAMP Pharma Corporation
1310 Nobel Street, Boucherville, Quebec,
J4B 5H3, Canada
|
|
|
Primary Sponsor
|
| Name |
JAMP Pharma Corporation |
| Address |
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 = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod Kumar A C |
Kempegowda Institute Of Medical Sciences |
Attimabbe Road, Banashankari 2nd Stage, Bangalore, Bangalore Urban, Karnataka - 560070
India
Bangalore
KARNATAKA |
9886244455
vinodabbur@gmail.com |
| Dr Paramesha K C |
KR Hospital |
KR Hospital, Mysore Medical College and Research Institute,Yadavagiri, Mysuru,560001
Mysore
KARNATAKA |
9343055819
parameshkennal@gmail.com |
| Dr Hrishikesh Patkar |
Lifepoint Multispeciality Hospital |
145/1, Mumbai Bangalore Highway, near Hotel Sayaji, Wakad, Pune 411057
Pune
MAHARASHTRA |
9730475068
patkarhrishikesh@gmail.com |
| Dr Rekha M C |
Mandya Institute of Medical Science |
3rd Cross, Bangalore Mysore Main road,Mandya, 571401
Mysore
KARNATAKA |
9738877298
drrekhamc@gmail.com |
| Dr Solunke Swaroop Shahaji |
Medipoint Hospitals Pvt Ltd |
241/1, New Dp Road, Aundh, Pune, - 411007,Maharashtra
Pune
MAHARASHTRA |
9921101070
drswaroopsolunke.medipoint@gmail.com |
| Dr Girish H R |
Rajalakshmi Hospital & Reasearch Center |
1121,Lakshmipura main road,vidyaranyapura post ,Bangalore
Bangalore
KARNATAKA |
9845516613
drgirishhr@gmail.com |
| Dr Santosh Saklecha |
Santosh Hospital |
6/1, Promenade Rd,Behind coles park Bengaluru, Karnataka
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
| Dr Peeyush Chansouria |
Shubham Sudhbhawana Superspeciality Hospital |
Shubham Sudhbhawana Superspeciality Hospital
B31/80,23 B- Bhogabir Lanka Varanasi
Uttar Pradesh- 221005
Varanasi
UTTAR PRADESH |
9336912471
sudbhawanacrvns@gmail.com |
| Dr Ravikumar |
Sparsh Super Specality Hospital |
#146,Infantry road,opposite police commissioner office, Bangalore
Bangalore
KARNATAKA |
9606197707
sparshclinical@gmail.com |
| Dr Alagu Pandiyan |
Sparsh Super Specialty Hospital |
#4/1 Tumkur road yeshwanthpur,Bangaluru
Bangalore
KARNATAKA |
8061222074
dr.alagu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
| KIMS Institutional Ethics Committee |
Approved |
| Lifepoint Research Ethics Committee |
Approved |
| Mandya Institute of Medical Sciences |
Approved |
| Mysore Medical College and Research Institute and Associated Hospitals |
Approved |
| Pentamed Ethics Committee |
Approved |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
| Santosh Hospital Institutional Ethics Committee |
Approved |
| Shubham Sudbhawana Super. Hosp. Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (P): Vehicle gel, Manufactured for- JAMP Pharma Corporation.
Manufactured by- GlaxoSmithKline Consumer Healthcare Inc., Canada (GSK) |
The subjects 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 4 times a day throughout the study duration of 7 days |
| Comparator Agent |
Reference Product (R): Voltaren Emulgel (Diclofenac diethylamine 1.16% w/w);
|
The subjects 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 4 times a
day throughout the study duration of 7 days. |
| Intervention |
Test product (T): Diclofenac diethylamine 1.16% w/w gel; Manufactured for- JAMP
Pharma Corporation |
The subjects 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 4 times a
day throughout the study duration of 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed by physical examination with acute strains Grade I and II (as
classified by the American Medicine Association system) or sprains Grade I
and II (as classified by The West Point Ankle Grading System).
2. Injury that has led to sprain/strain should have occurred within 24 h before
enrolment
3. Pain on movement of injured area [measured on a 100 mm visual analogue
scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain)] ≥ 35 mm
immediately prior to randomization.
4. Able to understand the requirements of the clinical trial and to agree to return
for the required follow-up visits.
5. Willing to provide voluntary written informed consent and data protection
declaration before any clinical trial related procedure is performed. |
|
| ExclusionCriteria |
| Details |
1. Ligament rupture or severe sprain not considered amenable to treatment with
topical NSAIDS alone.
2. Open skin lesion in the injured area
3. Clinical evidence of fracture
4. Dermatological conditions, such as eczema or skin infections on the injured
area
5. Use of medication (other than the study drugs) for the treatment of complaints caused by the affected area
6. Other inflammatory or painful conditions (e.g. headache, toothache).
7. Similar injury of the same area within the last 3 months
8. Debilitating acute/chronic illness,
9. 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).
10. Use of Systemic corticosteroid or immunosuppressive drugs in the previous 8
weeks.
11. Pregnant or lactating or planning to become pregnant during the study period.
12. Patients with or without chronic asthma in whom attacks of asthma, urticaria, or
acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal antiinflammatory agents
13. History of OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis)
or fibromyalgia.
14. History of asthma, hypertension, myocardial infarction, thrombotic events,
stroke, congestive heart failure, impaired renal function or liver disease.
15. History of gastrointestinal bleeding or peptic ulcer disease.
16. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
17. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or
methotrexate within the past month prior to entry into the study.
18. Women of child-bearing age who are not surgically incapable of pregnancy and
are unwilling to use an acceptable method of birth control.
19. Current participation or not yet completed period of at least 30 days since
ending other investigational device or drug trial(s);
20. Unwillingness or inability to comply with the clinical trial procedures.
21. Unwillingness to consent to storage, saving and transmission of pseudonymous
medical data for clinical trial reasons.
22. Patients who are deemed to be legally incapacitated.
23. Patients 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 clinical non-inferiority of the generic Diclofenac diethylamine 1.16% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel/GSK (Reference) in patients with acute localized muscle or joint injuries on relief of pain as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0–100) after seven days of treatment |
Day 0 (Baseline) & Day 7 (End of treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Mean change in VAS of pain on movement of injured area from baseline Day 0 to Day 3, baseline Day 0 to Day 5.
•Proportion of patients with reduction in VAS of pain on movement of injured area, Mean change in VAS of pain at rest, Proportion of patients with reduction in VAS of pain at rest, Mean change of normal function/activity of the injured area, Proportion of patient with improvement in normal function/activity of the injured area, Mean change of passive joint mobility in patients with sprains, Proportion of patient with improvement in passive joint mobility in patients with sprains from baseline Day 0 to Day 7, baseline Day 0 to Day 3 and baseline-Day 0 to Day 5. |
from baseline Day 0 to Day 7, baseline Day 0 to Day 3 and baseline-Day 0 to Day 5 |
|
|
Target Sample Size
|
Total Sample Size="255"
Sample Size from India="255"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2023 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Non-inferiority, Randomized, Double blind, Clinical Trial for Comparing the Efficacy
and Tolerability of Diclofenac diethylamine 1.16% w/w gel of JAMP Pharma vs
Voltaren Emulgel® (Diclofenac diethylamine 1.16% w/w) of GlaxoSmithKline
Consumer Healthcare Inc., Canada in Patients with acute localized muscle or joint
injuries. Sample size is 255: 102 patients for Test, 102 for Reference and 51 for Placebo, where the primary objective is to confirm the clinical non-inferiority of the generic Diclofenac diethylamine
1.16% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel/GSK
(Reference) in patients with acute localized muscle or joint injuries on relief of
pain as assessed by the patient by means of a 100 mm visual analogue scale
(VAS) (scoring range 0–100) 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. |