PMID- 28442928
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240325
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 10
DP  - 2017
TI  - The efficacy and safety of S-flurbiprofen plaster in the treatment of knee 
      osteoarthritis: a phase II, randomized, double-blind, placebo-controlled, 
      dose-finding study.
PG  - 867-880
LID - 10.2147/JPR.S131779 [doi]
AB  - BACKGROUND: Nonsteroidal anti-inflammatory drug (NSAID) patches are convenient 
      for use and show much less gastrointestinal side effects than oral NSAIDs, 
      whereas its percutaneous absorption is not sufficient for the expression of 
      clinical efficacy at satisfactory level. S-flurbiprofen plaster (SFPP) has shown 
      dramatic improvement in percutaneous absorption results from animal and clinical 
      studies. In this study, the efficacy and safety of SFPP were compared with 
      placebo in patients with knee osteoarthritis (OA) to determine its optimal dose. 
      This was a multicenter, randomized, double-blind, parallel-group comparative 
      study. PATIENTS AND METHODS: Enrolled 509 knee OA patients were treated with 
      placebo or SFPP at 10, 20, or 40 mg applied on the affected site once daily for 2 
      weeks. The primary endpoint for efficacy was improvement in knee pain on rising 
      from the chair assessed by visual analog scale (VAS). The other endpoints were 
      clinical symptoms, pain on walking, and global assessment by both investigator 
      and patient. Safety was evaluated by observing adverse events (AEs). RESULTS: VAS 
      change in knee pain from baseline to trial end was dose-dependent, least squares 
      mean was 29.5, 31.5, 32.0, and 35.6 mm in placebo and SFPP 10, 20, and 40 mg, 
      respectively. A significant difference was observed between placebo and SFPP 40 
      mg (P=0.001). In contrast, the effect of SFPP at a dose </=20 mg was not 
      significantly different from that of placebo. The proportion of the patients who 
      achieved 50% pain relief was 72.4% in 40 mg and 51.2% in placebo (P<0.001). In 
      all other endpoints, SFPP 40 mg showed significant improvement compared with 
      placebo. The incidence of AEs was not different across all four groups, and no 
      severe AEs were observed. CONCLUSION: Clinically relevant pain relief was 
      observed in all groups including placebo. Especially 40 mg showed remarkable pain 
      relief in not only primary endpoint but also all the other endpoint with 
      significant differences over placebo. The safety profile of SFPP 40 mg was not 
      different from that of placebo. Therefore, 40 mg was determined as the optimal 
      tested dose.
FAU - Yataba, Ikuko
AU  - Yataba I
AD  - Taisho Pharmaceutical Co, Ltd.
FAU - Otsuka, Noboru
AU  - Otsuka N
AD  - Taisho Pharmaceutical Co, Ltd.
FAU - Matsushita, Isao
AU  - Matsushita I
AD  - Taisho Pharmaceutical Co, Ltd.
FAU - Matsumoto, Hideo
AU  - Matsumoto H
AD  - Institute for Integrated Sports Medicine, School of Medicine, Keio University, 
      Tokyo.
FAU - Hoshino, Yuichi
AU  - Hoshino Y
AD  - Department of Orthopedics Surgery, School of Medicine, Jichi Medical University, 
      Tochigi, Japan.
LA  - eng
PT  - Journal Article
DEP - 20170411
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC5396977
OTO - NOTNLM
OT  - double-blind
OT  - nonsteroidal anti-inflammatory drugs
OT  - optimal dose
OT  - patch
OT  - randomized controlled trial
OT  - topical
OT  - visual analog scale
COIS- Disclosure Taisho Pharmaceutical funded this clinical trial. Taisho 
      Pharmaceutical was involved in the design of the study, its conduct, and the data 
      analysis. Ikuko Yataba, Noboru Otsuka, and Isao Matsushita are employees of 
      Taisho Pharmaceutical. Hideo Matsumoto has received consultancy fees from Taisho 
      Pharmaceutical. Yuichi Hoshino had received consultancy fees from Taisho 
      Pharmaceutical while in a previous affiliation. The authors report no other 
      conflicts of interest in this work.
EDAT- 2017/04/27 06:00
MHDA- 2017/04/27 06:01
PMCR- 2017/04/11
CRDT- 2017/04/27 06:00
PHST- 2017/04/27 06:00 [entrez]
PHST- 2017/04/27 06:00 [pubmed]
PHST- 2017/04/27 06:01 [medline]
PHST- 2017/04/11 00:00 [pmc-release]
AID - jpr-10-867 [pii]
AID - 10.2147/JPR.S131779 [doi]
PST - epublish
SO  - J Pain Res. 2017 Apr 11;10:867-880. doi: 10.2147/JPR.S131779. eCollection 2017.