Clin Orthop Surg.  2017 Dec;9(4):439-457. 10.4055/cios.2017.9.4.439.

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

Affiliations
  • 1Department of Orthopedic Surgery, Seoul National University Hospital, Seoul, Korea.
  • 2Department of Orthopedic Surgery, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
  • 3Department of Orthopedic Surgery, Konkuk University Medical Center, Seoul, Korea.
  • 4Clinical Research Center, Kyungpook National University Hospital, Daegu, Korea.
  • 5Department of Orthopedic Surgery, Asan Medical Center, Seoul, Korea.
  • 6Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, Seoul, Korea.
  • 7Department of Orthopedic Surgery, Hanyang University Seoul Hospital, Seoul, Korea.
  • 8Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 9Clinical Research Center, Chungnam National University Hospital, Daejeon, Korea.
  • 10Department of Orthopedic Surgery, Korea University Anam Hospital, Seoul, Korea.
  • 11Department of Orthopedic Surgery, Seoul St. Mary's Hospital, Seoul, Korea.
  • 12Department of Orthopedic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 13Department of Orthopedic Surgery, Ewha Womans University Mokdong Hospital, Seoul, Korea.
  • 14Department of Orthopedic Surgery, Korean Armed Forces Capital Hospital, Seongnam, Korea.
  • 15Clinical Research Department, CG Pharmaceuticals, Inc., Orinda, CA, USA. scho@cgxinc.com

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.

Keyword

Osteoarthritis; Polmacoxib; Placebo; Celecoxib; Cyclooxygenase 2 inhibitor

MeSH Terms

Adult
Aged
Aged, 80 and over
Celecoxib/adverse effects/*therapeutic use
Cyclooxygenase 2 Inhibitors/adverse effects/*therapeutic use
Double-Blind Method
Female
Furans/adverse effects/*therapeutic use
Gastrointestinal Diseases/chemically induced
Humans
Male
Middle Aged
Musculoskeletal Pain/*drug therapy/etiology
Osteoarthritis, Hip/complications/*drug therapy/physiopathology
Osteoarthritis, Knee/complications/*drug therapy/physiopathology
Range of Motion, Articular
Sulfonamides/adverse effects/*therapeutic use
Cyclooxygenase 2 Inhibitors
Furans
Sulfonamides
Celecoxib
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