Table 3. Summary Results* of Noninferiority and Superiority Tests on Change in WOMAC Index from Baseline to Weeks 3 and 6 as Primary and Secondary Endpoints in ITT Population: Observed Cases.
| Variable | Week 3 | Week 6 | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 67) | Polmacoxib 2 mg (n = 135) | Celecoxib 200 mg (n = 134) | Placebo (n = 66) | Polmacoxib 2 mg (n = 126) | Celecoxib 200 mg (n = 132) | |
| WOMAC-pain | ||||||
| LS mean change | −2.2 ± 0.90 (−3.9 to −0.4) |
−5.3 ± 0.74 (−6.7 to −3.8) |
−4.8 ± 0.74 (−6.2 to −3.3) |
−2.7 ± 1.02 (−4.7 to −0.7) |
−6.0 ± 0.84 (−7.6 to −4.3) |
−6.3 ± 0.83 (−7.9 to −4.7) |
| Comparisons vs. placebo | −3.1 ± 0.90 (−4.9 to −1.3) |
−2.6 ± 0.90 (−4.4 to −0.9) |
−3.2 ± 1.03 (−5.3 to −1.2) |
−3.6 ± 1.02 (−5.6 to −1.6) |
||
| p-value | 0.001 | 0.004 | 0.002 | 0.001 | ||
| Polmacoxib vs. celecoxib | −0.5 ± 0.73 (−1.9 to 0.9) |
0.4 ± 0.85 (−1.3 to 2.0) |
||||
| p-value | 0.501 | 0.669 | ||||
| Noninferiority (NI margin = 5) | Yes, UCI (0.9) is less than NI margin (5) | Yes, UCI (2.0) is less than NI margin (5) | ||||
| WOMAC-stiffness | ||||||
| LS mean change | −0.3 ± 0.34 (−1.0 to 0.4) |
−1.9 ± 0.26 (−2.4 to −1.3) |
−1.4 ± 0.26 (−1.9 to −0.8) |
−0.5 ± 0.45 (−1.4 to 0.4) |
−1.9 ± 0.38 (−2.7 to −1.2) |
−1.9 ± 0.37 (−2.6 to −1.2) |
| Comparisons vs. placebo | −1.6 ± 0.37 (−2.3 to −0.8) |
−1.0 ± 0.37 (−1.8 to −0.3) |
−1.5 ± 0.46 (−2.4 to −0.6) |
−1.4 ± 0.45 (−2.3 to −0.5) |
||
| p-value | < 0.001 | 0.005 | 0.002 | 0.002 | ||
| Polmacoxib vs. celecoxib | −0.5 ± 0.30 (−1.1 to 0.1) |
−0.0 ± 0.37 (−0.8 to 0.7) |
||||
| p-value | 0.094 | 0.941 | ||||
| Noninferiority (NI margin = 2) | Yes, UCI (0.1) is less than NI margin (2) | Yes, UCI (0.7) is less than NI margin (2) | ||||
| WOMAC-physical function | ||||||
| LS mean change | −6.1 ± 2.67 (−11.3 to −0.8) |
−14.9 ± 2.11 (−19.0 to −10.7) |
−11.6 ± 2.11 (−15.7 to −7.4) |
−8.4 ± 3.17 (−14.6 to −2.1) |
−16.7 ± 2.59 (−21.8 to −11.6) |
−16.2 ± 2.56 (−21.3 to −11.2) |
| Comparisons vs. placebo | −8.8 ± 2.85 (−14.4 to −3.2) |
−5.5 ± 2.85 (−11.1 to 0.1) |
−8.3 ± 3.29 (−14.8 to −1.9) |
−7.9 ± 3.26 (−14.3 to −1.5) |
||
| p-value | 0.002 | 0.055 | 0.012 | 0.016 | ||
| Polmacoxib vs. celecoxib | −3.3 ± 2.32 (−7.8 to 1.3) |
−0.4 ± 2.70 (−5.8 to 4.9) |
||||
| p-value | 0.16 | 0.868 | ||||
| Noninferiority (NI margin = 17) | Yes, UCI (1.3) is less than NI margin (17) | Yes, UCI (4.9) is less than NI margin (17) | ||||
| WOMAC-OA index | ||||||
| LS mean change | −8.5 ± 3.75 (−15.9 to −1.1) |
−22.1 ± 2.99 (−28.0 to −16.2) |
−17.8 ± 2.99 (−23.7 to −11.9) |
−11.5 ± 4.46 (−20.3 to −2.7) |
−24.7 ± 3.66 (−31.9 to −17.5) |
−24.5 ± 3.61 (−31.6 to −17.4) |
| Comparisons vs. placebo | −13.6 ± 3.94 (−21.3 to −5.8) |
−9.3 ± 3.94 (−17.0 to −1.5) |
−13.2 ± 4.59 (−22.2 to −4.2) |
−13.0 ± 4.55 (−22.0 to −4.1) |
||
| p-value | 0.001 | 0.019 | 0.004 | 0.004 | ||
| Polmacoxib vs. celecoxib | −4.3 ± 3.21 (−10.6 to 2.0) |
−0.2 ± 3.76 (−7.5 to 7.2) |
||||
| p-value | 0.183 | 0.967 | ||||
| Noninferiority (NI margin = 24) | Yes, UCI (2.0) is less than NI margin (24) | Yes, UCI (7.2) is less than NI margin (24) | ||||
Values are presented as mean ± standard error (95% confidence interval).
WOMAC: Western Ontario and McMaster Universities, ITT: intent-to-treat, LS: least square, NI: noninferiority, UCI: upper confidence interval, OA: osteoarthritis.
*Data obtained from a mixed-effects analysis of covariance model with fixed effects for treatment group and baseline pain score and a random effect for pooled site.