Trial reportClinics in orthopedic surgery2017
A Randomized, Multicenter, Phase III Trial to Evaluate the Efficacy and Safety of Polmacoxib Compared with Celecoxib and Placebo for Patients with Osteoarthritis.
Trial report in Clinics in orthopedic surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Factors Contributing to Variability in Longitudinal Pain Scores in Osteoarthritis Randomised Clinical Trials: A Systematic Review and Meta-Analysis.European journal of pain (London, England) · 2026Pooled it
- Effects of Analgesics on Self-Reported Physical Function and Walking Ability in People With Hip or Knee Osteoarthritis: A Systematic Review and Meta-Analysis.Physical therapy · 2024Pooled it
- Polmacoxib 2mg in patients with mild to moderate idiopathic osteoarthritis of hip/knee-a randomized, double-anonymous study.Pain management · 2024Trial
- Clinical Pharmacokinetics of Polmacoxib (CG100649): A Tissue-Selective Dual COX-2 and Carbonic Anhydrase I/II Inhibitor.Clinical pharmacokinetics · 2026Review
- Article
- Recent advances in the synthesis of antidepressant derivatives: pharmacologic insights for mood disorders.3 Biotech · 2024Review
- Renal effects of selective cyclooxygenase-2 inhibitor anti-inflammatory drugs: A systematic review and meta-analysis.Exploratory research in clinical and social pharmacy · 2024Review
- Polmacoxib: A Review of the Newer Non-steroidal Anti-inflammatory Drug in Osteoarthritis.Cureus · 2024Review
- Cardiovascular Implications of Non-steroidal Anti-inflammatory Drugs: A Comprehensive Review, with Emphasis on Patients with Rheumatoid Arthritis.European cardiology · 2024Review
- An Unusual Case of Colon Perforation With Multiple Transmural Ulcers After Use of Polmacoxib and Everolimus in a Metastatic Breast Cancer Patient.Annals of coloproctology · 2021Article
- Natural Products as Sources of Novel Drug Candidates for the Pharmacological Management of Osteoarthritis: A Narrative Review.Biomolecules & therapeutics · 2019Review
- Change of miRNA expression profiles in patients with knee osteoarthritis before and after celecoxib treatment.Journal of clinical laboratory analysis · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 13 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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).
methodsThis 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.
resultsAfter 6 weeks, the polmacoxib-placebo treatment difference was -2.5 (95% confidence interval [CI], -4.4 to -0.6;
conclusionsPolmacoxib 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.