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A Randomized, Multicenter, Phase III Trial to Evaluate the Efficacy and Safety of Polmacoxib Compared with Celecoxib and Placebo for Patients with Osteoarthritis

 Myungchul Lee  ;  Juhyung Yoo  ;  Jin Goo Kim  ;  Hee-Soo Kyung  ;  Seong-Il Bin  ;  Seung-Baik Kang  ;  Choong Hyeok Choi  ;  Young-Wan Moon  ;  Young-Mo Kim  ;  Seong Beom Han  ;  Yong In, MD  ;  Chong Hyuk Choi  ;  Jongoh Kim  ;  Beom Koo Lee  ;  Sangsook Cho 
Journal Title
Issue Date
Adult ; Aged ; Aged, 80 and over ; Celecoxib/adverse effects ; Celecoxib/therapeutic use* ; Cyclooxygenase 2 Inhibitors/adverse effects ; Cyclooxygenase 2 Inhibitors/therapeutic use* ; Double-Blind Method ; Female ; Furans/adverse effects ; Furans/therapeutic use* ; Gastrointestinal Diseases/chemically induced ; Humans ; Male ; Middle Aged ; Musculoskeletal Pain/drug therapy* ; Musculoskeletal Pain/etiology ; Osteoarthritis, Hip/complications ; Osteoarthritis, Hip/drug therapy* ; Osteoarthritis, Hip/physiopathology ; Osteoarthritis, Knee/complications ; Osteoarthritis, Knee/drug therapy* ; Osteoarthritis, Knee/physiopathology ; Range of Motion, Articular ; Sulfonamides/adverse effects ; Sulfonamides/therapeutic use*
Celecoxib ; Cyclooxygenase 2 inhibitor ; Osteoarthritis ; Placebo ; Polmacoxib
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.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Chong Hyuk(최종혁) ORCID logo https://orcid.org/0000-0002-9080-4904
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