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, Chong Hyuk Choi, Jongoh Kim, Beom Koo Lee, Sangsook Cho

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6 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)439-457
Number of pages19
JournalClinics in Orthopedic Surgery
Volume9
Issue number4
DOIs
StatePublished - 2017

Keywords

  • Celecoxib
  • Cyclooxygenase 2 inhibitor
  • Osteoarthritis
  • Placebo
  • Polmacoxib

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