PMID- 27168463
OWN - NLM
STAT- MEDLINE
DCOM- 20170406
LR  - 20220817
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 27
IP  - 1
DP  - 2017 Jan
TI  - Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment: Results from 
      a phase III, randomized, active-controlled, adequate, and well-controlled trial.
PG  - 130-136
LID - 10.1080/14397595.2016.1176624 [doi]
AB  - 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.
FAU - Yataba, Ikuko
AU  - Yataba I
AD  - a Development Headquarters, Taisho Pharmaceutical Co., Ltd. , Tokyo , Japan.
FAU - Otsuka, Noboru
AU  - Otsuka N
AD  - a Development Headquarters, Taisho Pharmaceutical Co., Ltd. , Tokyo , Japan.
FAU - Matsushita, Isao
AU  - Matsushita I
AD  - a Development Headquarters, Taisho Pharmaceutical Co., Ltd. , Tokyo , Japan.
FAU - Matsumoto, Hideo
AU  - Matsumoto H
AD  - b Institute for Integrated Sports Medicine, School of Medicine, Keio University , 
      Tokyo , Japan , and.
FAU - Hoshino, Yuichi
AU  - Hoshino Y
AD  - c Orthopedics Surgery, School of Medicine, Jichi Medical University , Tochigi , 
      Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160511
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 5GRO578KLP (Flurbiprofen)
SB  - IM
CIN - Int J Rheum Dis. 2022 Jul;25(7):723-724. PMID: 35898159
MH  - Administration, Topical
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/*therapeutic use
MH  - Female
MH  - Flurbiprofen/administration & dosage/*therapeutic use
MH  - Humans
MH  - Knee Joint
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Pain/*drug therapy
MH  - Pain Measurement
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adequate and well-controlled trial
OT  - NSAIDs
OT  - Osteoarthritis
OT  - Pain
OT  - S-flurbiprofen
EDAT- 2016/05/12 06:00
MHDA- 2017/04/07 06:00
CRDT- 2016/05/12 06:00
PHST- 2016/05/12 06:00 [pubmed]
PHST- 2017/04/07 06:00 [medline]
PHST- 2016/05/12 06:00 [entrez]
AID - 10.1080/14397595.2016.1176624 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2017 Jan;27(1):130-136. doi: 10.1080/14397595.2016.1176624. Epub 
      2016 May 11.