PMID- 29201297 OWN - NLM STAT- MEDLINE DCOM- 20180207 LR - 20220311 IS - 2005-4408 (Electronic) IS - 2005-291X (Print) IS - 2005-291X (Linking) VI - 9 IP - 4 DP - 2017 Dec TI - A Randomized, Multicenter, Phase III Trial to Evaluate the Efficacy and Safety of Polmacoxib Compared with Celecoxib and Placebo for Patients with Osteoarthritis. PG - 439-457 LID - 10.4055/cios.2017.9.4.439 [doi] AB - BACKGROUND: The aim of this study was to evaluate the safety and analgesic efficacy of polmacoxib 2 mg versus placebo in a superiority comparison or versus celecoxib 200 mg in a noninferiority comparison in patients with osteoarthritis (OA). METHODS: This study was a 6-week, phase III, randomized, double-blind, and parallel-group trial followed by an 18-week, single arm, open-label extension. Of the 441 patients with knee or hip OA screened, 362 were randomized; 324 completed 6 weeks of treatment and 220 completed the extension. Patients were randomized to receive oral polmacoxib 2 mg (n = 146), celecoxib 200 mg (n = 145), or placebo (n = 71) once daily for 6 weeks. During the extension, all participants received open-label polmacoxib 2 mg. The primary endpoint was the change in Western Ontario and McMaster Universities (WOMAC)-pain subscale score from baseline to week 6. Secondary endpoints included WOMAC-OA Index, OA subscales (pain, stiffness, and physical function) and Physician's and Subject's Global Assessments at weeks 3 and 6. Other outcome measures included adverse events (AEs), laboratory tests, vital signs, electrocardiograms, and physical examinations. RESULTS: After 6 weeks, the polmacoxib-placebo treatment difference was -2.5 (95% confidence interval [CI], -4.4 to -0.6; p = 0.011) and the polmacoxib-celecoxib treatment difference was 0.6 (CI, -0.9 to 2.2; p = 0.425). According to Physician's Global Assessments, more subjects were "much improved" at week 3 with polmacoxib than with celecoxib or placebo. Gastrointestinal and general disorder AEs occurred with a greater frequency with polmacoxib or celecoxib than with placebo. CONCLUSIONS: Polmacoxib 2 mg was relatively well tolerated and demonstrated efficacy superior to placebo and noninferior to celecoxib after 6 weeks of treatment in patients with OA. The results obtained during the 18-week trial extension with polmacoxib 2 mg were consistent with those observed during the 6-week treatment period, indicating that polmacoxib can be considered safe for long-term use based on this relatively small scale of study in a Korean population. More importantly, the results of this study showed that polmacoxib has the potential to be used as a pain relief drug with reduced gastrointestinal side effects compared to traditional nonsteroidal anti-inflammatory drugs for OA. FAU - Lee, Myungchul AU - Lee M AD - Department of Orthopedic Surgery, Seoul National University Hospital, Seoul, Korea. FAU - Yoo, Juhyung AU - Yoo J AD - Department of Orthopedic Surgery, National Health Insurance Service Ilsan Hospital, Goyang, Korea. FAU - Kim, Jin Goo AU - Kim JG AD - Department of Orthopedic Surgery, Konkuk University Medical Center, Seoul, Korea. FAU - Kyung, Hee-Soo AU - Kyung HS AD - Clinical Research Center, Kyungpook National University Hospital, Daegu, Korea. FAU - Bin, Seong-Il AU - Bin SI AD - Department of Orthopedic Surgery, Asan Medical Center, Seoul, Korea. FAU - Kang, Seung-Baik AU - Kang SB AD - Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, Seoul, Korea. FAU - Choi, Choong Hyeok AU - Choi CH AD - Department of Orthopedic Surgery, Hanyang University Seoul Hospital, Seoul, Korea. FAU - Moon, Young-Wan AU - Moon YW AD - Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. FAU - Kim, Young-Mo AU - Kim YM AD - Clinical Research Center, Chungnam National University Hospital, Daejeon, Korea. FAU - Han, Seong Beom AU - Han SB AD - Department of Orthopedic Surgery, Korea University Anam Hospital, Seoul, Korea. FAU - In, Yong AU - In Y AD - Department of Orthopedic Surgery, Seoul St. Mary's Hospital, Seoul, Korea. FAU - Choi, Chong Hyuk AU - Choi CH AD - Department of Orthopedic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Kim, Jongoh AU - Kim J AD - Department of Orthopedic Surgery, Ewha Womans University Mokdong Hospital, Seoul, Korea. FAU - Lee, Beom Koo AU - Lee BK AD - Department of Orthopedic Surgery, Korean Armed Forces Capital Hospital, Seongnam, Korea. FAU - Cho, Sangsook AU - Cho S AD - Clinical Research Department, CG Pharmaceuticals, Inc., Orinda, CA, USA. LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Equivalence Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20171110 PL - Korea (South) TA - Clin Orthop Surg JT - Clinics in orthopedic surgery JID - 101505087 RN - 0 (CG100649) RN - 0 (Cyclooxygenase 2 Inhibitors) RN - 0 (Furans) RN - 0 (Sulfonamides) RN - JCX84Q7J1L (Celecoxib) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Celecoxib/adverse effects/*therapeutic use MH - Cyclooxygenase 2 Inhibitors/adverse effects/*therapeutic use MH - Double-Blind Method MH - Female MH - Furans/adverse effects/*therapeutic use MH - Gastrointestinal Diseases/chemically induced MH - Humans MH - Male MH - Middle Aged MH - Musculoskeletal Pain/*drug therapy/etiology MH - Osteoarthritis, Hip/complications/*drug therapy/physiopathology MH - Osteoarthritis, Knee/complications/*drug therapy/physiopathology MH - Range of Motion, Articular MH - Sulfonamides/adverse effects/*therapeutic use PMC - PMC5705303 OTO - NOTNLM OT - Celecoxib OT - Cyclooxygenase 2 inhibitor OT - Osteoarthritis OT - Placebo OT - Polmacoxib COIS- CONFLICT OF INTEREST: No potential conflict of interest relevant to this article was reported. EDAT- 2017/12/05 06:00 MHDA- 2018/02/08 06:00 PMCR- 2017/12/01 CRDT- 2017/12/05 06:00 PHST- 2017/06/05 00:00 [received] PHST- 2017/09/21 00:00 [accepted] PHST- 2017/12/05 06:00 [entrez] PHST- 2017/12/05 06:00 [pubmed] PHST- 2018/02/08 06:00 [medline] PHST- 2017/12/01 00:00 [pmc-release] AID - 10.4055/cios.2017.9.4.439 [doi] PST - ppublish SO - Clin Orthop Surg. 2017 Dec;9(4):439-457. doi: 10.4055/cios.2017.9.4.439. Epub 2017 Nov 10.