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

Phase 3 Completed 385 enrolled GlaxoSmithKline

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2013-11-01
Primary completion: 2015-03-01
Completion: 2015-03-22

Publications

Lai PM, Collaku A, Reed K. Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial. J Int Med Res. 2017 Apr;45(2):647-661. doi: 10.1177/0300060517700322. Epub 2017 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	1 %	Topical
Subject	Menthol	Small molecule	0.09 %	Topical
Subject	Menthol	Small molecule	3 %	Topical

Indications

No indication recorded.