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Introduction <p>Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70&#xa0;mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).</p> Methods <p>In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7&#xa0;days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).</p> Results <p>A total of 180 adult patients (mean age 34.5 ± 13.5&#xa0;years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3&#xa0;mm at baseline; at 72&#xa0;h POM had reduced by 59.0&#xa0;mm and 33.3&#xa0;mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0&#xa0;mm (<i>p</i>&#xa0;value for analysis of covariance &lt; 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (<i>p</i> &lt; 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as ‘good’ or ‘very good’. The responder rate (proportion of patients with at least 50% pain reduction at 72&#xa0;h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. The plasters adhered well over the 24-h dosing period and were very well tolerated.</p> Conclusion <p>In the setting of acute sprains, strains and contusions (bruises) the etofenamate plaster has therapeutic efficacy that is comparable to that for the best available topical NSAID formulations.</p> Registration <p>2021-003778-30 (EudraCT number).</p>

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A Randomized Placebo-Controlled Trial of the Efficacy and Tolerability of Etofenamate 70 mg Medicated Plaster for the Treatment of Pain in Acute Sprains, Strains or Bruises of the Soft Tissues Following Blunt Trauma

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  • 发表日期：

    2025年7月17日

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  • Hans-Georg Predel,
  • Andrew C. Leary,
  • Roger Imboden,
  • Ralph-Steven Wedemeyer,
  • Bruno M. Giannetti

摘要

Introduction

Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70 mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).

Methods

In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7 days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).

Results

A total of 180 adult patients (mean age 34.5 ± 13.5 years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3 mm at baseline; at 72 h POM had reduced by 59.0 mm and 33.3 mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0 mm (p value for analysis of covariance < 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (p < 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as ‘good’ or ‘very good’. The responder rate (proportion of patients with at least 50% pain reduction at 72 h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. The plasters adhered well over the 24-h dosing period and were very well tolerated.

Conclusion

In the setting of acute sprains, strains and contusions (bruises) the etofenamate plaster has therapeutic efficacy that is comparable to that for the best available topical NSAID formulations.

Registration

2021-003778-30 (EudraCT number).