WOMAC pain score (mm) at baseline, mean change from baseline to the average of Weeks 4 and 6, and differences between treatment groups of the full analysis set. Calculated using ANCOVA with treatment, country grouping (Australia, USA, Europe) and baseline pain as covariates.
| Placebo, n = 79 | Naproxcinod 750 mg qd, n = 102 | Naproxcinod 750 mg bid, n = 114 | Naproxcinod 1125 mg bid, n = 118 | Rofecoxib 25 mg qd, n = 109 | |
|---|---|---|---|---|---|
| Baseline, mean (SD) | 64.0 (16.78) | 65.8 (17.49) | 62.3 (18.75) | 62.5 (16.75) | 63.8 (16.89) |
| Change from baseline to the average of Weeks 4 and 6* | |||||
| Mean (SD) | −20.5 (22.17) | −28.5 (22.49) | −33.6 (20.31) | −33.3 (21.74) | −37.0 (22.04) |
| LS mean (SE) | −20.2 (2.35) | −27.6 (2.08) | −34.0 (1.96) | −33.5 (1.93) | −36.7 (2.01) |
| 95% CI | −24.8, − 15.6 | −31.7, −23.5 | −37.8, −30.1 | −37.3, −29.7 | −40.7, −32.8 |
| Comparisons vs placebo** | |||||
| LS mean (SE) | −7.4 (3.13) | −13.8 (3.05) | −13.3 (3.03) | −16.5 (3.08) | |
| 95% CI | (−13.6, −1.3) | (−19.8, −7.8) | (−19.3, −7.4) | (−22.6, −10.5) | |
| p | 0.0181 | < 0.0001 | < 0.0001 | < 0.0001 | |
| Comparisons vs rofecoxib 25 mg qd** | |||||
| LS mean (SE) | 9.1 (2.88) | 2.8 (2.79) | 3.2 (2.77) | ||
| 95% CI | (3.5, 14.8) | (−2.7, 8.2) | (−2.2, 8.7) | ||
| p | 0.0016 | 0.3246 | 0.2474 | ||
| Comparisons vs naproxcinod 1125 mg bid** | |||||
| LS mean (SE) | 5.9 (2.83) | −0.5 (2.74) | |||
| 95% CI | (0.4, 11.5) | (−5.8, 4.9) | |||
| p | 0.0370 | 0.8684 | |||
| Comparisons vs naproxcinod 750 mg bid** | |||||
| LS mean (SE) | 6.4 (2.85) | ||||
| 95% CI | (0.8, 12.0) | ||||
| p | 0.0259 | ||||