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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

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dc.contributor.author최종혁-
dc.date.accessioned2018-07-20T12:04:54Z-
dc.date.available2018-07-20T12:04:54Z-
dc.date.issued2017-
dc.identifier.issn2005-291X-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161739-
dc.description.abstractBackground: 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.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherKorean Orthopaedic Association-
dc.relation.isPartOfCLINICS IN ORTHOPEDIC SURGERY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHCelecoxib/adverse effects-
dc.subject.MESHCelecoxib/therapeutic use*-
dc.subject.MESHCyclooxygenase 2 Inhibitors/adverse effects-
dc.subject.MESHCyclooxygenase 2 Inhibitors/therapeutic use*-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHFemale-
dc.subject.MESHFurans/adverse effects-
dc.subject.MESHFurans/therapeutic use*-
dc.subject.MESHGastrointestinal Diseases/chemically induced-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHMusculoskeletal Pain/drug therapy*-
dc.subject.MESHMusculoskeletal Pain/etiology-
dc.subject.MESHOsteoarthritis, Hip/complications-
dc.subject.MESHOsteoarthritis, Hip/drug therapy*-
dc.subject.MESHOsteoarthritis, Hip/physiopathology-
dc.subject.MESHOsteoarthritis, Knee/complications-
dc.subject.MESHOsteoarthritis, Knee/drug therapy*-
dc.subject.MESHOsteoarthritis, Knee/physiopathology-
dc.subject.MESHRange of Motion, Articular-
dc.subject.MESHSulfonamides/adverse effects-
dc.subject.MESHSulfonamides/therapeutic use*-
dc.titleA Randomized, Multicenter, Phase III Trial to Evaluate the Efficacy and Safety of Polmacoxib Compared with Celecoxib and Placebo for Patients with Osteoarthritis-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Orthopedic Surgery-
dc.contributor.googleauthorMyungchul Lee-
dc.contributor.googleauthorJuhyung Yoo-
dc.contributor.googleauthorJin Goo Kim-
dc.contributor.googleauthorHee-Soo Kyung-
dc.contributor.googleauthorSeong-Il Bin-
dc.contributor.googleauthorSeung-Baik Kang-
dc.contributor.googleauthorChoong Hyeok Choi-
dc.contributor.googleauthorYoung-Wan Moon-
dc.contributor.googleauthorYoung-Mo Kim-
dc.contributor.googleauthorSeong Beom Han-
dc.contributor.googleauthorYong In, MD-
dc.contributor.googleauthorChong Hyuk Choi-
dc.contributor.googleauthorJongoh Kim-
dc.contributor.googleauthorBeom Koo Lee-
dc.contributor.googleauthorSangsook Cho-
dc.identifier.doi10.4055/cios.2017.9.4.439-
dc.contributor.localIdA04187-
dc.relation.journalcodeJ00620-
dc.identifier.eissn2005-4408-
dc.identifier.pmid29201297-
dc.subject.keywordCelecoxib-
dc.subject.keywordCyclooxygenase 2 inhibitor-
dc.subject.keywordOsteoarthritis-
dc.subject.keywordPlacebo-
dc.subject.keywordPolmacoxib-
dc.contributor.alternativeNameChoi, Chong Hyuk-
dc.contributor.affiliatedAuthorChoi, Chong Hyuk-
dc.citation.volume9-
dc.citation.number4-
dc.citation.startPage439-
dc.citation.endPage457-
dc.identifier.bibliographicCitationCLINICS IN ORTHOPEDIC SURGERY, Vol.9(4) : 439-457, 2017-
dc.identifier.rimsid59356-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers

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