Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study

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

Outcome

Met primary endpoint

paper the upper limit (5.22 mm) of the 95% CI was less than the noninferiority margin of 13 mm PMID 36566202 ↗

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

Indications

No indication recorded.