Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment: Results from a phase III, randomized, active-controlled, adequate, and well-controlled trial

Ikuko Yataba, Noboru Otsuka, Isao Matsushita, Hideo Matsumoto, Yuichi Hoshino

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)

Abstract

Objectives: S-flurbiprofen plaster (SFPP) is a novel non-steroidal anti-inflammatory drug (NSAID) patch, intended for topical treatment for musculoskeletal diseases. This trial was conducted to examine the effectiveness of SFPP using active comparator, flurbiprofen (FP) patch, on knee osteoarthritis (OA) symptoms. Methods: This was a phase III, multi-center, randomized, adequate, and well-controlled trial, both investigators and patients were blinded to the assigned treatment. Enrolled 633 knee OA patients were treated with either SFPP or FP patch for two weeks. The primary endpoint was improvement in knee pain on rising from the chair as assessed by visual analogue scale (rVAS). Safety was evaluated through adverse events (AEs). Results: The change in rVAS was 40.9 mm in SFPP group and 30.6 mm in FP patch group (p < 0.001). The incidence of drug-related AEs at the application site was 9.5% (32 AEs, 29 mild and 3 moderate) in SFPP and 1.6% in FP patch (p < 0.001). Withdrawals due to AE were five in SFPP and one in FP patch. Conclusions: The superiority of SFPP in efficacy was demonstrated. Most of AEs were mild and few AEs led to treatment discontinuation. Therefore, SFPP provides an additional option for knee OA therapy.

Original languageEnglish
Pages (from-to)130-136
Number of pages7
JournalModern rheumatology
Volume27
Issue number1
DOIs
Publication statusPublished - 2017 Jan 2

Keywords

  • Adequate and well-controlled trial
  • NSAIDs
  • Osteoarthritis
  • Pain
  • S-flurbiprofen

ASJC Scopus subject areas

  • Rheumatology

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