Table 3

 Estimated differences (estimate (SEM)) in WOMAC score and MDHAQ pain and gastrointestinal distress visual analogue scales between treatment groups during period I, period II, and both periods for PACES clinical trials.

Celecoxib-acetaminophenp ValueCelecoxib-placebop ValueAcetaminophen-placebop ValueCarryover p§
*Results are from an analysis of covariance for visit 3-visit 2 with treatment, visit 1, visit 2, and centre as covariates; †results are from an analysis of covariance for visit 5-visit 4 with treatment, visit 1, visit 4, and centre as covariates; ‡results are from an analysis using GEE for visit 3−visit 2 and visit 5−visit 4 with treatment, period, visit 1, visit 2, baseline as covariates; §from an analysis using GEE with the model described in footnote ‡ expanded to include a two degrees of freedom test for carry over.
3A. PACES-a
WOMAC target joint
Period I*−2.78 (2.07)0.180−6.47 (2.06)0.002−3.69 (2.10)0.080
Period II†−4.03 (1.55)0.009−4.79 (1.77)0.007−0.75 (1.85)0.683
Both periods‡−3.41 (1.02)<0.001−5.50 (1.14)<0.001−2.09 (1.20)0.0800.827
MDHAQ visual analogue pain score
Period I*−3.47 (2.66)0.193−9.25 (2.63)<0.001−5.78 (2.68)0.031
Period II†−6.49 (2.17)0.003−7.66 (2.47)0.002−1.17 (2.28)0.651
Both periods‡−4.88 (1.50)0.001−8.90 (1.73)<0.001−4.02 (1.73)0.020.602
MDHAQ patient gastrointestinal distress visual analogue scale
Period I*−4.83 (2.30)0.036−2.54 (2.30)0.2692.29 (2.33)0.327
Period II†−2.35 (1.47)0.110−4.97 (1.68)0.003−2.62 (1.75)0.136
Both periods‡−1.19 (1.22)0.333−3.16 (1.49)0.034−1.97 (1.60)0.2170.167
B. PACES-b
WOMAC target joint
Period I*−4.99 (1.83)0.007−9.09 (1.83)<0.001−4.10 (1.84)0.027
Period II†−4.99 (1.48)<0.001−6.53 (1.69)<0.001−1.53 (1.77)0.387
Both periods‡−4.62 (1.00)<0.001−7.70 (1.12)<0.001−3.08 (1.10)0.0050.937
MDHAQ visual analogue pain score
Period I*−7.69 (2.54)0.003−13.84 (2.54)<0.001−6.15 (2.55)0.016
Period II†−4.11 (2.13)0.054−9.98 (2.43)<0.001−5.87 (2.54)0.021
Both periods‡−5.87 (1.41)<0.001−12.24 (1.68)<0.001−6.38 (1.64)<0.0010.614
MDHAQ patient gastrointestinal distress visual analogue scale
Period I*−3.22 (2.16)0.136−2.54 (2.14)0.2360.68 (2.16)0.755
Period II†−4.87 (2.00)0.015−0.72 (2.29)0.7544.15 (2.39)0.084
Both periods‡−3.51 (1.35)0.009−1.84 (1.30)0.1561.68 (1.34)0.2100.486