Table 2 Per protocol analysis of primary and secondary end points
Variable | Pelubiprofen 30 mg (n =62) | Celecoxib 200 mg (n =58) | Difference | |
|---|---|---|---|---|
Mean (SD) | 97.5% CI, one-sided | |||
Patient’s pain VAS, 0–100 mm, mean (SD) | ||||
Week 0 | 69.1 (17.2) | 64.0 (19.3) | ||
Week 6 | 42.9 (21.4) | 42.7 (24.2) | ||
Difference (Week 0 – Week 6) | 26.2 (19.5) | 21.2 (20.8) | 5.0 (20.1) | −2.3, ∞ |
KHAQ, mean (SD) | ||||
Week 0 | 1.0 (0.7) | 1.0 (0.7) | ||
Week 6 | 0.8 (0.7) | 0.8 (0.7) | ||
Difference (Week 0 – Week 6) | 0.2 (0.5) | 0.2 (0.5) | 0.0 (0.5) | −0.2, ∞ |
Duration of morning stiffness, min, median | ||||
Week 0 | 30.0 | 30.0 | ||
Week 6 | 10.0 | 15.0 | ||
Difference (Week 0 – Week 6)* | 0.0 | 0.0 | ||
Frequency of rescue medication, times in last two weeks, mean (SD) | ||||
Week 0 | 2.8 (4.0) | 2.2 (3.2) | ||
Week 6 | 1.4 (2.9) | 1.5 (3.4) | ||
Difference (Week 0 – Week 6) | 1.4 (3.7) | 0.7 (3.4) | 0.7 (3.5) | −0.6, ∞ |
Total dose of rescue medication, tablets in last two weeks, mean (SD) | ||||
Week 0 | 3.0 (4.0) | 2.2 (3.2) | ||
Week 6 | 1.6 (3.1) | 1.5 (3.6) | ||
Difference (Week 0 – Week 6) | 1.4 (3.6) | 0.7 (3.5) | 0.7 (3.6) | −0.6, ∞ |