Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 최충혁 | - |
dc.date.accessioned | 2019-11-30T07:41:29Z | - |
dc.date.available | 2019-11-30T07:41:29Z | - |
dc.date.issued | 2017-09 | - |
dc.identifier.citation | CLINICS IN ORTHOPEDIC SURGERY, v. 9, no. 4, page. 439-457 | en_US |
dc.identifier.issn | 2005-291X | - |
dc.identifier.issn | 2005-4408 | - |
dc.identifier.uri | https://synapse.koreamed.org/DOIx.php?id=10.4055/cios.2017.9.4.439 | - |
dc.identifier.uri | https://repository.hanyang.ac.kr/handle/20.500.11754/115457 | - |
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. | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | KOREAN ORTHOPAEDIC ASSOC | en_US |
dc.subject | Osteoarthritis | en_US |
dc.subject | Polmacoxib | en_US |
dc.subject | Placebo | en_US |
dc.subject | Celecoxib | en_US |
dc.subject | Cyclooxygenase 2 inhibitor | en_US |
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 | en_US |
dc.type | Article | en_US |
dc.relation.no | 4 | - |
dc.relation.volume | 9 | - |
dc.identifier.doi | 10.4055/cios.2017.9.4.439 | - |
dc.relation.page | 439-457 | - |
dc.relation.journal | CiOS Clinics in Orthopedic Surgery | - |
dc.contributor.googleauthor | Lee, Myungchul | - |
dc.contributor.googleauthor | Yoo, Juhyung | - |
dc.contributor.googleauthor | Kim, Jin Goo | - |
dc.contributor.googleauthor | Kyung, Hee-Soo | - |
dc.contributor.googleauthor | Bin, Seong-Il | - |
dc.contributor.googleauthor | Kang, Seung-Baik | - |
dc.contributor.googleauthor | Choi, Choong Hyeok | - |
dc.contributor.googleauthor | Moon, Young-Wan | - |
dc.contributor.googleauthor | Kim, Young-Mo | - |
dc.contributor.googleauthor | Choi, Chong Hyuk | - |
dc.relation.code | 2017023923 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | chhchoi | - |
dc.identifier.orcid | http://orcid.org/0000-0002-9080-4904 | - |
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