A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain

• Status: Completed
• Trial end date: 2015-03-22
• Target enrollment: 0
• Participant gender: All

Summary

This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical MFC51123 gel registration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Diclofenac; Menthol

Criteria

Inclusion Criteria:

• Age: 16-65 years

• Good general and mental health

• Grade I or Grade II acute sprain of the lateral ankle within 24 hours of Visit 1, a pain intensity score of the ankle sprain that is ≥ 5 as measured on an 11-point numerical rating scale, and a peri-malleolar edema (sub-malleolar perimeter difference of ≥ 20mm between injured and uninjured ankle

• Females of child-bearing age practicing a reliable method of contraception

Exclusion Criteria:

• Pregnant or breast-feeding females

• If participant has treated the ankle sprain with treatment such as oral or other topical pain relief medications, massage or physical therapy since experiencing the ankle sprain

• Acute or chronic pain disorders, which may confound the study pain evaluations

• Participant has has injury to both ankles or to both medial and lateral ligaments of the same ankle

• Known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications

• Participant has a medical history of renal or hepatic disease, a current active peptic ulcer or a history of upper gastrointestinal bleeding or perforation related to previous NSAID therapy