Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 김종오 | - |
dc.date.accessioned | 2018-11-23T16:30:09Z | - |
dc.date.available | 2018-11-23T16:30:09Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 2005-291X | - |
dc.identifier.other | OAK-23770 | - |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/247020 | - |
dc.description.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. © 2017 by The Korean Orthopaedic Association. | - |
dc.language | English | - |
dc.publisher | Korean Orthopaedic Association | - |
dc.subject | Celecoxib | - |
dc.subject | Cyclooxygenase 2 inhibitor | - |
dc.subject | Osteoarthritis | - |
dc.subject | Placebo | - |
dc.subject | Polmacoxib | - |
dc.title | A randomized, multicenter, phase III trial to evaluate the efficacy and safety of polmacoxib compared with celecoxib and placebo for patients with osteoarthritis | - |
dc.type | Article | - |
dc.relation.issue | 4 | - |
dc.relation.volume | 9 | - |
dc.relation.index | SCOPUS | - |
dc.relation.index | KCI | - |
dc.relation.startpage | 439 | - |
dc.relation.lastpage | 457 | - |
dc.relation.journaltitle | CiOS Clinics in Orthopedic Surgery | - |
dc.identifier.doi | 10.4055/cios.2017.9.4.439 | - |
dc.identifier.scopusid | 2-s2.0-85036548331 | - |
dc.author.google | Lee M. | - |
dc.author.google | Yoo J. | - |
dc.author.google | Kim J.G. | - |
dc.author.google | Kyung H.-S. | - |
dc.author.google | Bin S.-I. | - |
dc.author.google | Kang S.-B. | - |
dc.author.google | Choi C.H. | - |
dc.author.google | Moon Y.-W. | - |
dc.author.google | Kim Y.-M. | - |
dc.author.google | Han S.B. | - |
dc.author.google | In Y. | - |
dc.author.google | Kim J. | - |
dc.author.google | Lee B.K. | - |
dc.author.google | Cho S. | - |
dc.contributor.scopusid | 김종오(55720229000;57219658058) | - |
dc.date.modifydate | 20220329105941 | - |