Table 2

 Primary efficacy outcomes observed in patients with osteoarthritis (intent to treat and per protocol populations)

OutcomesIDEA-033CelecoxibPlacebo
LS, least squares; PGA, patient global assessment; WOMAC, Western Ontario and McMaster Universities;
*Statistically significant difference (p<0.05) compared with placebo.
Results are given as changes from baseline to end of study unless stated otherwise.
Intent-to treat population (n)138132127
WOMAC Index
    Mean (SD) change in pain score−19.4 (21.2)−20.7 (22.7)−12.4 (20.8)
        LS mean (SE) change−18.2 (2.0)*−20.3 (2.1)*−9.9 (2.1)
        95% CI−22.1 to −14.3−24.3 to −16.2−13.9 to −5.8
        p Value, comparison with placebo0.00410.0004
    Mean (SD) change in physical function score−16.0 (20.3)−18.1 (22.5)−12.3 (19.2)
        LS mean (SE) change−14.6 (1.8)−16.6 (1.8)*−10.2 (1.8)
        95% confidence interval−18.1 to −11.0−20.2 to −13.0−13.8 to −6.6
        p Value, comparison with placebo0.080.01
PGA of response at end of study
    None (0), n (%)35 (25.4)34 (25.8)51 (40.2)
    Poor (1), n (%)16 (11.6)23 (17.4)20 (15.7)
    Fair (2), n (%)23 (16.7)24 (18.2)21 (16.5)
    Good (3), n (%)48 (34.8)37 (28.0)30 (23.6)
    Excellent (4), n (%)16 (11.6)14 (10.6)5 (3.9)
    Mean (SD) score2.2 (1.3)1.9 (1.3)1.5 (1.3)
    LS mean (SE) score1.8 (0.1)*1.7 (0.1)*1.3 (0.1)
    95% CI1.6 to 2.11.5 to 1.91.1 to 1.5
    p Value, comparison with placebo<0.010.02