Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study

Phase 3 Completed 313 enrolled GlaxoSmithKline

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of diclofenac diethylamine 2.32 percent (%) gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily for 7 days in participants with acute ankle sprain.

Timeline

Start: 2019-10-24
Primary completion: 2020-11-12
Completion: 2020-11-12

Publications

Yin F, Ma J, Xiao H, Ao R, Zhang F, Li W, Wang W, Zeng P, Lu T, Revel FB, Araga M, Patel S, Moreira S, Zhang J, Zhang W. Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain. BMC Musculoskelet Disord. 2022 Dec 24;23(1):1125. doi: 10.1186/s12891-022-06077-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac diethylamine	Unknown	1.16 %	Topical
Subject	Diclofenac diethylamine	Unknown	2.32 %	Topical

Indications

No indication recorded.