Table 1.
Baseline demographic and clinical characteristics
| Celecoxib 200 mg qd (n = 145) | Naproxen 500 mg bid (n = 144) | Placebo (n = 78) | P‐value | |
|---|---|---|---|---|
|
Age, years, mean (SD) (Range) |
65.9 (11.1) (42–90) |
64.1 (11.4) (45–88) |
63.9 (11.1) (45–88) |
0.491 |
| Female, n (%) | 97 (67) | 98 (68) | 52 (67) | 0.989 |
| Duration of OA, years, mean (SD) | 4.5 (4.0) | 4.8 (5.5) | 4.6 (4.3) | 0.619 |
| [n = 127†] | [n = 128†] | [n = 68†] | ||
|---|---|---|---|---|
| Patients' Global Assessment, n (%) | 0.1346 | |||
| Very good | 0 | 0 | 0 | |
| Good | 0 | 1 (< 1) | 0 | |
| Fair | 24 (17) | 30 (21) | 19 (24) | |
| Poor | 109 (75) | 103 (72) | 56 (72) | |
| Very poor | 12 (8) | 10 (7) | 3 (4) | |
| Physician's Global Assessment, n (%) | 0.0553 | |||
| Very good | 0 | 0 | 1 (1) | |
| Good | 0 | 1 (< 1) | 1 (1) | |
| Fair | 25 (17) | 30 (21) | 19 (24) | |
| Poor | 116 (80) | 106 (74) | 56 (72) | |
| Very poor | 4 (3) | 7 (5) | 1 (1) | |
| Functional capacity classification, n (%) | 0.5096 | |||
| I | 6 (4) | 5 (4) | 4 (5) | |
| II | 119 (83) | 118 (82) | 66 (85) | |
| III | 19 (13) | 21 (15) | 8 (10) | |
| IV | 0 | 0 | 0 | |
| VAS score, mm, mean (SD) | 64.6 (12.2) | 65.8 (11.7) | 64.4 (13.0) | 0.5984 |
| WOMAC total score, mean (SD)‡ | 50.1 (15.5) | 51.2 (14.0) | 50.5 (16.0) | 0.8121 |
†Non‐missing included only. ‡WOMAC total domain score is the sum of pain, stiffness and physical function domain scores. Continuous measures were analyzed by a general linear model with factors for treatment and center. Categorical data were analyzed using the Cochran‐Mantel‐Haenszel test, stratified by center. bid, twice daily; OA, osteoarthritis; qd, once daily; SD, standard deviation; VAS, visual analogue scale; WOMAC, Western Ontario and McMaster Universities OA Index.