PMID- 31920367
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220412
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 12
DP  - 2019
TI  - Efficacy And Safety Of Controlled-Release Oxycodone For The Management Of 
      Moderate-To-Severe Chronic Non-Cancer Pain In Japanese Patients: Results From An 
      Open-Label Study.
PG  - 3423-3436
LID - 10.2147/JPR.S210502 [doi]
AB  - PURPOSE: To assess the efficacy and safety of S-8117, an oral, controlled-release 
      formulation of oxycodone hydrochloride, in Japanese patients with chronic 
      non-cancer pain (CNCP). PATIENTS AND METHODS: In this multicenter, 
      non-randomized, open-label, 2-part (part 1, dose-titration followed by 
      maintenance period; part 2, long-term administration period) study at 38 centers 
      in Japan (2013-2015), adult patients with CNCP for >/=12 weeks were administered 
      S-8117. The primary endpoint was proportion of patients with successful 
      maintenance of pain control in part 1 and long-term safety in part 2. Secondary 
      endpoints included time to inadequate analgesia, rate of transition to the 
      maintenance period, and discontinuation due to inadequate analgesia/adverse 
      events (AEs), Brief Pain Inventory (BPI) pain severity, BPI pain interference, 
      36-item Short Form Health Survey (SF-36) score, and Western Ontario and McMaster 
      Universities (WOMAC) index, Subjective Opioid Withdrawal Scale (SOWS), Clinical 
      Opioid Withdrawal Scale (COWS), Dependency-2-A (D-2-A), and Dependency-2-B 
      (D-2-B) questionnaires. RESULTS: Of 130 patients (mean age, 63.6 years; women, 
      62.3%) in the dose-titration period, 95 entered the maintenance period; 60 of 83 
      who entered the long-term administration period completed it. The proportion of 
      patients (95% confidence interval) with successful maintenance of pain control, 
      transition to maintenance period, and discontinuation due to inadequate 
      analgesia/AEs was 78.9% (69.4-86.6), 73.1% (64.6-80.5), and 21.1% (13.4-30.6), 
      respectively. Time to inadequate analgesia could not be estimated. Changes from 
      baseline in BPI, SF-36, and WOMAC index scores suggested improvements in pain 
      relief and quality of life. Based on the SOWS, COWS, D-2-A and D-2-B 
      questionnaires, no patient developed clinically relevant withdrawal syndrome or 
      was ascertained to have developed drug dependence. Overall, the incidence of 
      treatment-emergent AEs (TEAEs) was 93.8%; most common TEAEs were constipation 
      (49.2%), nausea (42.3%), nasopharyngitis (34.6%), and somnolence (32.3%). 
      CONCLUSION: These results demonstrate the efficacy and safety of S-8117 in 
      Japanese patients with CNCP.
CI  - (c) 2019 Kawamata et al.
FAU - Kawamata, Mikito
AU  - Kawamata M
AUID- ORCID: 0000-0002-4483-3026
AD  - Department of Anesthesiology and Resuscitology, Shinshu University School of 
      Medicine, Matsumoto, Japan.
FAU - Iseki, Masako
AU  - Iseki M
AUID- ORCID: 0000-0002-8693-1900
AD  - Department of Anesthesiology and Pain Medicine, Juntendo University Faculty of 
      Medicine, Tokyo, Japan.
FAU - Kawakami, Mamoru
AU  - Kawakami M
AUID- ORCID: 0000-0002-2182-3132
AD  - Spine Care Center, Wakayama Medical University Kihoku Hospital, Wakayama, Japan.
FAU - Yabuki, Shoji
AU  - Yabuki S
AUID- ORCID: 0000-0003-3647-3718
AD  - Department of Orthopaedic Surgery, Fukushima Medical University School of 
      Medicine, Fukushima, Japan.
FAU - Sasaki, Takuma
AU  - Sasaki T
AD  - Clinical Development Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Ishida, Mitsuhiro
AU  - Ishida M
AUID- ORCID: 0000-0002-9815-7190
AD  - Clinical Development Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Nishiyori, Atsushi
AU  - Nishiyori A
AD  - Clinical Development Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Hida, Hideaki
AU  - Hida H
AD  - Biostatistics Center, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Kikuchi, Shin-Ichi
AU  - Kikuchi SI
AD  - Department of Orthopaedic Surgery, Fukushima Medical University School of 
      Medicine, Fukushima, Japan.
LA  - eng
PT  - Journal Article
DEP - 20191223
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC6934115
OTO - NOTNLM
OT  - Japan
OT  - analgesics
OT  - chronic pain
OT  - opioids
COIS- Mikito Kawamata received personal fees from Shionogi & Co., Ltd., research grant 
      from Otsuka Pharmaceutical Co., Ltd., and both personal fees and research grant 
      from Nippon Zoki Pharmaceutical Co., Ltd. Shin-ichi Kikuchi received a grant from 
      Shionogi & Co., Ltd., and personal fees from Shionogi & Co., Ltd., and Japan 
      Agency for Medical Research and Development. Masako Iseki and Mamoru Kawakami 
      received grants and personal fees from Shionogi & Co., Ltd. Shoji Yabuki received 
      personal fees from Pfizer Japan Inc., and both personal fees and research grants 
      from Shionogi & Co., Ltd., and Janssen Pharmaceutical K. K. Mitsuhiro Ishida, 
      Takuma Sasaki, and Hideaki Hida are employees and shareholders of Shionogi & Co., 
      Ltd. Atsushi Nishiyori is an employee of Shionogi & Co., Ltd. The authors report 
      no other conflicts of interest in this work.
EDAT- 2020/01/11 06:00
MHDA- 2020/01/11 06:01
PMCR- 2019/12/23
CRDT- 2020/01/11 06:00
PHST- 2019/03/29 00:00 [received]
PHST- 2019/10/19 00:00 [accepted]
PHST- 2020/01/11 06:00 [entrez]
PHST- 2020/01/11 06:00 [pubmed]
PHST- 2020/01/11 06:01 [medline]
PHST- 2019/12/23 00:00 [pmc-release]
AID - 210502 [pii]
AID - 10.2147/JPR.S210502 [doi]
PST - epublish
SO  - J Pain Res. 2019 Dec 23;12:3423-3436. doi: 10.2147/JPR.S210502. eCollection 2019.