title: Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment: Results from a phase III, randomized, active-controlled, adequate, and well-controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: a Development Headquarters, Taisho Pharmaceutical Co., Ltd. , Tokyo , Japan.
authors.forename: Ikuko
authors.initials: I
authors.lastname: Yataba
authors.affiliation: a Development Headquarters, Taisho Pharmaceutical Co., Ltd. , Tokyo , Japan.
authors.forename: Noboru
authors.initials: N
authors.lastname: Otsuka
authors.affiliation: a Development Headquarters, Taisho Pharmaceutical Co., Ltd. , Tokyo , Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Matsushita
authors.affiliation: b Institute for Integrated Sports Medicine, School of Medicine, Keio University , Tokyo , Japan , and.
authors.forename: Hideo
authors.initials: H
authors.lastname: Matsumoto
authors.affiliation: c Orthopedics Surgery, School of Medicine, Jichi Medical University , Tochigi , Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Hoshino
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005480:Flurbiprofen / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007719:Knee Joint; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005480:Flurbiprofen
keywords: Adequate and well-controlled trial; NSAIDs; Osteoarthritis; Pain; S-flurbiprofen