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This Article Full Text Full Text (PDF) All Versions of this Article: 33/4/515    most recent 0363546504268135v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mazières, B. Articles by Reiner, V. Search for Related Content PubMed PubMed Citation Articles by Mazières, B. Articles by Reiner, V. Related Collections Ankle Nonoperative

Topical Ketoprofen Patch (100 mg) for the Treatment of Ankle Sprain

A Randomized, Double-Blind, Placebo-Controlled Study

Bernard Mazières, MD^*,, Stéphanie Rouanet, DESS, Joanne Velicy, PhD, Claudia Scarsi, PharM and Valentina Reiner, PharB

From the Department of Rheumatology, Rangueil University Hospital, Toulouse, France, Therapharm Researches, Boulogne-Billancourt, France, and Applied Pharma Research S.A., Balerna, Switzerland

^* Address correspondence to Bernard Mazières, MD, Department of Rheumatology, Rangueil University Hospital, 1, Avenue Jean-Poulhes, 31059–Toulouse Cedex 9, France (e-mail: mazieres{at}cict.fr).

Background: Topical nonsteroidal anti-inflammatory drugs offer the advantage of enhanced drug delivery to local affected tissues with low plasma levels and an expected reduced incidence of systemic adverse events (mainly peptic ulcer disease and gastrointestinal hemorrhage).

Hypothesis: To test the efficacy and tolerability of a 100-mg patch of ketoprofen applied once a day.

Study Design: Randomized controlled clinical trial; Level of evidence, 1.

Methods: The 2-week trial included patients suffering painful (spontaneous pain 50 mm on a 0- to 100-mm visual analog scale), benign (grade I or II), recent (<2 days) ankle sprains as a model of general traumatic soft tissue injuries. The primary efficacy criterion was spontaneous pain change after 7 days of treatment in the intention-to-treat population. One hundred sixty-three patients were randomized (ketoprofen, 81; placebo, 82).

Results: After 1 week of treatment, the decrease in spontaneous pain was –50 ± 20 mm for ketoprofen and –38 ± 24 mm for the placebo, showing a statistically significant intergroup difference (P = .0007). The majority of the secondary criteria were also statistically significant in favor of the ketoprofen patch. Tolerance was good in both groups, adverse events being mostly local.

Conclusion: This trial suggested that a 7-day course of treatment with a ketoprofen patch is useful in benign ankle sprain, without revealing unexpected adverse events.

Key Words: ankle sprain • ketoprofen • patch • soft tissue injuries • randomized controlled trial

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