Journal
MODERN RHEUMATOLOGY
Volume 27, Issue 1, Pages 130-136Publisher
SPRINGER
DOI: 10.1080/14397595.2016.1176624
Keywords
Adequate and well-controlled trial; NSAIDs; Osteoarthritis; Pain; S-flurbiprofen
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Funding
- Taisho Pharmaceutical Co., Ltd
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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 40.9mm in SFPP group and 30.6mm 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.
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