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- Title
Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment: Results from a phase III, randomized, active-controlled, adequate, and well-controlled trial.
- Authors
Ikuko Yataba; Noboru Otsuka; Isao Matsushita; Hideo Matsumoto; Yuichi Hoshino
- 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 40.9mm in SFPP group and 30.6mm in FP patch group (p50.001). 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 (p50.001). 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.
- Subjects
KNEE osteoarthritis; OSTEOARTHRITIS treatment; KNEE pain; RANDOMIZED controlled trials; VISUAL analog scale
- Publication
Modern Rheumatology, 2017, Vol 27, Issue 1, p130
- ISSN
1439-7595
- Publication type
Article
- DOI
10.1080/14397595.2016.1176624