Diclofenac epolamine topical patch relieves pain associated with ankle sprain
David R Lionberger1, Eric Joussellin2, Arturo Lanzarotti3, Jillmarie Yanchick4, Merrell Magelli5
1Southwest Orthopedic Group, LLP, Houston, Texas, USA; 2Institut National du Sport, Paris, France; 3Institut Biochimique SA, Pambionoranco, Switzerland; 4Alpharma Pharmaceuticals LLC, a wholly owned subsidiary of King Pharmaceuticals®, Inc, Piscataway, New Jersey, USA; 5GTx, Inc, Memphis, Tennessee, USA
Background: Sports-related injuries, such as sprains and strains, commonly occur during exercise and athletic events. Current therapy includes nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of upper gastrointestinal side effects. The present study assessed the efficacy and safety of the diclofenac epolamine topical patch (DETP, 1.3%), a topical NSAID for the treatment of acute minor sprains and strains.
Methods: This multicenter, randomized, placebo-controlled clinical study enrolled adult patients (n = 134) with acute ankle pain (due to a minor sprain) occurring less than 48 hours prior to entering the study. Patients were treated with either the DETP or a placebo topical patch daily for seven days. Pain intensity was evaluated during the first six hours after application of the patch, and on treatment days 1, 2, 3, and 7.
Results: Patients treated with the DETP experienced a significantly greater reduction in pain associated with their ankle injury compared with placebo, beginning four hours after the first patch application (P = 0.02). The DETP was well tolerated and was comparable with placebo in terms of safety.
Conclusion: Overall, the results of this study demonstrate that the DETP is an effective analgesic for local treatment of pain in mild acute ankle sprain.
Keywords: soft tissue injury, acute pain, visual analog scale, efficacy, tolerability
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