Table 2. Primary and Secondary Analysis Results.
| Outcome | Placebo | Meloxicam | Adjusted difference, placebo minus meloxicam | |||
|---|---|---|---|---|---|---|
| Participants with available outcome data, No. | LS mean (SE) value | Participants with available outcome data, No. | LS mean (SE) value | Mean (95% CI) | P value | |
| Primary analysis | ||||||
| WOMAC knee pain at week 4 (possible range, 0-20)a | 152 | 8.0 (0.2) | 169 | 6.6 (0.2) | 1.4 (0.8 to 2.0) | .92b |
| Secondary analyses | ||||||
| WOMAC knee pain | ||||||
| At week 14a | 140 | 6.9 (0.2) | 146 | 6.0 (0.2) | 0.8 (0.2 to 1.4) | .28b |
| In final weekc | 176 | 6.6 (0.3) | 179 | 6.1 (0.3) | 0.6 (−0.1 to 1.3) | .12b |
| Time-averaged AUCd | ||||||
| Weeks 1-4 | 167 | 7.7 (0.2) | 173 | 6.7 (0.2) | 1.1 (0.5 to 1.6) | <.001e |
| Over all weeks | 175 | 7.5 (0.2) | 179 | 6.4 (0.2) | 1.1 (0.5 to 1.6) | <.001e |
| Global impression of change in final week (possible range, 1-5)f,g | 160 | 2.1 (0.1) | 176 | 2.3 (0.1) | −0.2 (−0.4 to 0.1) | .15e |
| WOMAC function in final week (possible range, 0-68)g | 160 | 19.7 (0.9) | 176 | 18.8 (0.9) | 0.9 (−1.4 to 3.2) | .45e |
Abbreviations: AUC, area under the curve; LS, least-squares; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.
Results for the first 2 outcomes (WOMAC knee pain at week 4 and 14) were obtained from a linear mixed model. The model included all participants with at least 1 postrandomization pain score (176 placebo and 179 meloxicam). Results for the other outcomes were obtained from linear regression models. All models were adjusted for the stratification variables (baseline WOMAC knee pain score and site).
Noninferiority (1-sided); P < .03.
Last observation carried forward.
Time-averaged AUC = AUC divided by the length of follow-up in weeks.
Difference (2-sided); P < .05.
Global impression of change range: 1 indicates much better and 5 indicates much worse.
Final week (≥12 for all participants).