Evaluation of Polmacoxib 2 mg for the Management of Hip and Knee Osteoarthritis: A Prospective, Single-Arm, Multicenter, Open-Label Study
Bibliographic record
Abstract
PURPOSE: Polmacoxib is a novel cyclooxygenase-2 (COX-2) selective inhibitor with effective analgesic and anti-inflammatory properties and a favorable safety profile. This study evaluated polmacoxib's effectiveness, onset of action, and tolerability in Indian patients with knee or hip osteoarthritis. METHOD: This was a prospective, multicenter, single-arm, open-label, observational study among Indian patients with knee/hip osteoarthritis. All patients with knee/hip osteoarthritis received polmacoxib capsule 2 mg orally once daily for six weeks. Patients were followed up for eight weeks (six weeks of treatment + two-week follow-up). Outcomes evaluated were pain, stiffness, and physical function using Western Ontario and McMaster Universities Arthritis Index (WOMAC) (CRD Pune version), severity of pain by Visual Analog Scale (VAS), and time of onset of action (in minutes), post-taking the first dose of polmacoxib 2 mg capsule on Day 1. Safety and compliance were monitored throughout the study period. RESULTS: In the study, 150 (male: female, 89:61) patients with a mean (standard deviation, or SD) age of 46.6 (9.9) years were enrolled. Statistically and clinically significant improvements were observed in all parameters. The mean (SD) pain score on the WOMAC Index declined significantly by -2.6 (2.1) and -5.9 (3.1) at Weeks 3 and 6, respectively, compared to the baseline score of 11.4 (4.6). Compared to the baseline mean (SD) score of 4.9 (2.1), the stiffness score on the WOMAC Index declined significantly by -1.0 (1.0) at Week 3, and by -2.4 (1.3) at Week 6. Mean (SD) difficulty (in physical function) score on the WOMAC Index declined significantly by -7.8 (5.9) and by -19.8 (10.2) at Weeks 3 and 6 respectively, compared to the baseline score of 41.6 (15.7), leading to a significant decline in total WOMAC Index by -11.4 (7.9) and by -28.1 (13.8) at Weeks 3 and 6 respectively, compared to the baseline score of 57.9 (21.9). The mean (SD) intensity of pain score (VAS) also declined significantly by -1.3 (1.3) and -2.9 (1.9) at Weeks 3 and 6, respectively, compared to the baseline score of 7.5 (0.9). Six (4.0%), 69 (46.0%), 62 (41.3%), and 13 (8.7%) of patients reported the onset of action of the study drug within 15, 30, 45, and 60 minutes of the first dose, respectively. The drug was well tolerated, with only 2% of patients experiencing mild, unrelated adverse events. Tolerability was rated "Excellent to Very Good" in 96.0% of cases by investigators and 89.3% of patients. CONCLUSION: Polmacoxib 2 mg demonstrated early onset of symptom relief, significant improvements in clinical symptoms, and an acceptable safety and tolerability profile over a six-week treatment period, suggesting that polmacoxib is a well-tolerated treatment option for osteoarthritis patients necessitating effective and rapid symptom control with minimal systemic side effects.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".