| CTRI Number |
CTRI/2026/01/100879 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Etofenamate 10 percent w/w gel versus Diclofenac 1.16 percent w/w gel |
|
Scientific Title of Study
|
A Multicentric, Randomized, Double-blind, Parallel Group, Two Arm, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Etofenamate 10 percent w/w gel versus Diclofenac 1.16 percent w/w gel in patients with musculoskeletal
pain |
| Trial Acronym |
ETOFENAMATE study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLL/CT/ETF/0724/01 Version No. 1 dated 03-JUL-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director |
| Affiliation |
Mediclin Clinical Research |
| Address |
107, Prime Trade Center,
BLDG No- 1/A, Vasai East 401208,
Mumbai
MAHARASHTRA
401208
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
Senior GM - Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
| Sponsor Micro Labs Limited # 31, Race Course Road, Bangalore Karnataka India 560001
and
CRO Mediclin Clinical Research
2nd Floor, A Wing, Ritu Horizon,
Next to Ankur School, Kanakiya Road,
Mira Road (E), Thane, Maharashtra, India - 401107 |
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
31 race course road Bangalore 560001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Micro Labs Limited |
31 race course road Bangalore 560001 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrashekara S |
ChanRe Rheumatology and Immunology Center and Research |
ChanRe
Rheumatology and
Immunology
Center and
Research 65,
Metro station, 414,
20th Main Rd, near
Rajajinagar, West
of Chord Road 2nd
Stage, Bengaluru,
Karnataka -
560010
Bangalore
KARNATAKA |
98450 71151
chandrashekara_s@yahoo.com |
| Dr Diptak Bhowmik |
College of Medicine & Sagore Dutta Hospital, Kolkata |
Dept of Medicine, College of
Medicine & Sagore
Dutta Hospital,
578 B. T. Road,
Kamarhati,
Kolkata - 700058,
West Bengal.
Kolkata
WEST BENGAL |
8777047635
diptak86@gmail.com |
| Dr Vijay Kumar Jain |
Dr. Ram Manohar Lohia Hospital, New Dehli |
Dept of Orthopedics, Dr. Ram Manohar Lohia Hospital, New Dehli 110001
New Delhi
DELHI |
9968277722
drvijayortho@gmail.com |
| Dr Prashant Tonape |
Dr. Tonape’s Genesis Hospital and Rehabilitation Centre, Mumbai |
6th floor, Renuka
Avenue, Dr.
Tonape’s Genesis
Hospital and
Rehabilitation
Centre, Bihand
Key Hotel, Old
Mumbai - Pune
Hwy, Morewadi,
Pimpri Colony,
Pimpri-
Chinchwad,
Maharashtra
411018
Mumbai
MAHARASHTRA |
9850133323
genesis.hospital1974@gmail.com |
| Dr Ankit Patel |
GCS Medical College, Hospital and Research Centre |
Dept of Orthopedics
GCS Medical College, Hospital and Research Centre Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road 380025
Ahmadabad
GUJARAT |
7043738888
drankit3103@gmail.com |
| Dr Arnab Karmakar |
GD Hospital & Diabetes Institute |
Dept of Orthopedoics, GD Hospital & Diabetes Institute
139 A, Lenin Sarani Rd, Bowbazar, Kolkata, West Bengal 700013
Kolkata
WEST BENGAL |
07980672908
arnab.doctor@gmail.com |
| Dr Sunil Naik |
Govt Medical College and Govt General Hospital (Old RIMSGGH), Srikakulam |
Dept of Medicine,
Govt Medical
College and Govt
General Hospital
(Old RIMSGGH),
Srikakulam-
532001, Andhra
Pradesh, India.
Srikakulam
ANDHRA PRADESH |
9440828299
rimsresearch@gmail.com |
| Dr Amit Bhaskar |
Janta Hospital Varanasi |
Janta Hospital &
Maternity Centre,
Amara-Akhari
Bypass, Varanasi -
221011, UP
Varanasi
UTTAR PRADESH |
9198677778
dramitbhaskarvns@gmail.com |
| Dr Manish Kumar Sharma |
Jawaharlal Nehru Medical College, Ajmer |
Dept of Orthopedics, Jawaharlal Nehru
Medical College,
Kala Bagh Ajmer -
305001 Rajasthan
India
Ajmer
RAJASTHAN |
7727861818
dr.mmanishsharma@gmail.com |
| Dr Arun G R |
Mysore Medical College & Research Institute, Princess Krishnajammanni Super Speciality Hospital, |
Dept of Orthopedics,
Princess
Krishnajammanni
Super Speciality
Hospital, Mysore Medical
College &
Research Institute, lst cross
Rd, Brindavan
Extension l st
stage, opposite to
ESI Hospital,
Mysuru Karnataka-
570015
Mysore
KARNATAKA |
9633254370
drarungr@gmail.com |
| Dr Kiran Kumar Mukhopadhyay |
Nil Ratan Sircar Medical College and Hospital, Kolkata |
Dept of Orthopedics, Nil Ratan Sircar
Medical College
and Hospital, 138,
Acharya Jagdish
Chandra Bose Rd,
Sealdah, Raja
Bazar, Kolkata,
West Bengal-
700014.
Kolkata
WEST BENGAL |
9433166270
orthokiran@gmail.com |
| Dr Nilesh Nolkha |
Nirjara Multispecialty Hospital, Mumbai, |
Dept of Rheumatology, Nirjara
Multispecialty
Hospital, Super
Shopping
Complex, Bajaj
Cross Road, near
popin shop,
Kandivali, Jethava
Nagar, Kandivali
West, Mumbai
Mumbai
MAHARASHTRA |
99203556655
drnileshnolkha@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Ethics Committee NRS Medical College and Hospital |
Approved |
| Ethics Committee PGIMER Dr RML Hospital |
Approved |
| Ethics Committee, College of Medicine and Sagore Dutta Hospital |
Approved |
| Ford Hospital Ethics Committee |
Approved |
| IEC GCS Medical College, Hospital |
Approved |
| IEC-MMC and RI And Associated Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE HORIZON LIFELINE HORIZON LIFELINE PVT LTD |
Approved |
| Institutional Ethics Committee, Government General Hospital, Srikakulam |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| lnstitutional Ethics Committee CRICR ChanRe Rheumatology Immunology Center Research |
Approved |
| Shah Lifeline Hospital And Heart Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac 1.16 percent w/w gel |
A 5-10 cm strip of gel according to the area affected should be rubbed in gently. Apply topically 4 times daily |
| Intervention |
Etofenamate 10 percent w/w gel |
A 5-10 cm strip of gel according to the area affected should be rubbed in gently. Apply topically 4 times daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects less than equal to 18 years to less than equal to 70 years both inclusive
2. Subject with any musculoskeletal pain
3. Subjects with at least moderate pain of less than equal to 4 to less than equal to 7 as measured by VAS.
4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
|
|
| ExclusionCriteria |
| Details |
1. Women of childbearing potential if pregnant (test positive for pregnancy) at the screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
2. Subjects with known hypersensitivity to any component of study medication.
3. Subjects with painful musculoskeletal conditions, who need parenteral therapy/surgery/hospital admission for management.
4. Use of any other topical preparation at the application site.
5. Subjects with concomitant skin disease at the application site.
6. Any condition that, in the opinion of the Investigator, could affect study parameters.
7. Subjects are not willing to follow the protocol of the study.
8. Participation in another clinical trial within the past 30 days.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in intensity of pain from the baseline to Day 7 as assessed by a 10 cm VAS (0 = no pain; 10 = worst pain).
|
Day 0 and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage change in intensity of pain from baseline to day 7 as assessed by a 10 cm VAS (0 = no pain; 10 = worst pain).
|
0 and day 7 |
| The assessment of safety will be based on the frequency of Adverse Events and Changes in laboratory parameters. |
Day 0 and Day 7 |
| Tolerability assessment by the investigator after treatment based on a 4-point scale at the end of study |
Day 7 |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
Final Enrollment numbers achieved (Total)= "228"
Final Enrollment numbers achieved (India)="228" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2026 |
| Date of Study Completion (India) |
26/08/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/08/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
Musculoskeletal pain is prevalent worldwide and greatly impacts the quality of life, social participation and economic burden. National & International Guidelines,
Recommend to consider Topical NSAIDs and/or Paracetamol as first-line therapy ahead of Oral NSAIDs, COX-2 inhibitors or Opioids. Etofenamate is a Non-Steroidal Anti-Inflammatory Drug (NSAID). Etofenamate is not yet approved in India and this study is conducted to Evaluate the Efficacy, Safety and Tolerability of Etofenamate 10 % w/w gel versus Diclofenac 1.16 % w/w gel in patients with musculoskeletal pain The study
demonstrates statistically significant and clinically meaningful improvement in
pain with Etofenamate 10% gel, with a
favourable safety and tolerability profile over the 7-day treatment period. The
findings support the efficacy, safety and tolerability of Etofenamate 10% w/w
gel in Indian subjects with musculoskeletal pain, in comparison with Diclofenac
1.16% w/w gel. |