Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Etofenamate 10 percent w/w gel versus Diclofenac 1.16 percent w/w gel

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 - ETOFENAMATE study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100879

Enrollment

228

Registered

2026-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: 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 Control Intervention1: Diclofenac 1.16 pe

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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). Timepoint: Day 0 and Day 7	—

Secondary

Measure	Time frame
Percentage change in intensity of pain from baseline to day 7 as assessed by a 10 cm VAS (0 = no pain; 10 = worst pain). Timepoint: 0 and day 7;The assessment of safety will be based on the frequency of Adverse Events and Changes in laboratory parameters.Timepoint: Day 0 and Day 7;Tolerability assessment by the investigator after treatment based on a 4-point scale at the end of studyTimepoint: Day 7	—

Measure

Time frame

Percentage change in intensity of pain from baseline to day 7 as assessed by a 10 cm VAS (0 = no pain; 10 = worst pain). Timepoint: 0 and day 7;The assessment of safety will be based on the frequency of Adverse Events and Changes in laboratory parameters.Timepoint: Day 0 and Day 7;Tolerability assessment by the investigator after treatment based on a 4-point scale at the end of studyTimepoint: Day 7

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Countries

India

Contacts

Public ContactDr Krishna Kumar M

Mediclin Clinical Research

ravindra.mote@mediclincr.com8888884024

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026