To Evaluate The Efficacy And Safety of Aceclofenac Topical Gel For The Treatment of Sprain and Muscle Pain

A Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study To Evaluate The Efficacy And Safety of Aceclofenac Topical Gel 5% w/w Compare with HIFENAC GEL® 1.5% w/w For The Treatment of Sprain and Muscle Pain

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/05/004577

Enrollment

200

Registered

2014-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: M628- Other specified disorders of muscle

Interventions

Intervention1: Aceclofenac Topical Gel 5% w/w: 2 gm medication will be applied topically gently to cover the affected skin area twice daily for 7-14 days. Control Intervention1: HIFENAC Gel® 1.5% w/w:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex between 18-65 years of age. 2. Patients with painful sprain and/or muscle pain. 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.

Exclusion criteria

Exclusion criteria: 1. Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion. 2. Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management. 3. Patient with history of osteoarthritis / rheumatoid arthritis. 4. Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application. 5. Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study. 6. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient. 7. Patients with history of severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 8. Known hypersensitivity to aspirin, aceclofenac or any other ingredient of product. 9. 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. 10. Participation in any other clinical trial during last 30 days.

Design outcomes

Primary

Measure	Time frame
1. Overall clinical response based on 50% relief in patient pain. 2. Pain intensity (Based on VAS).Timepoint: 7-14 days	—

Secondary

Measure	Time frame
1. Physician’s Global Assessment Scale. 2. Need for rescue medication.Timepoint: 7-14 days	—

Countries

India

Contacts

Public ContactMr Prasad Virkar

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026