Placebo | PRU 2 mg | PRU 4 mg | |
Primary QOL endpoint | |||
PAC-QOL satisfaction subscale score, mean (mean change from baseline)† | |||
Baseline | 3.17 (0.048) | 3.12 (0.054) | 3.08 (0.051) |
Week 12 | 2.85 (0.075) | 2.34 (0.080) | 2.22 (0.087) |
Change from baseline† | −0.30 (0.082) | (−0.76)*** (0.093) | (−0.87)*** (0.097) |
Secondary QOL endpoints | |||
Improvement ⩾1 PAC-QOL satisfaction subscale score from baseline, n/N (%) | |||
Week 12 | 34/207 (16.4%) | 69/206 (33.5%)*** | 53/180 (29.4%)*** |
Overall PAC-QOL score, mean (mean change from baseline)† | |||
Baseline | 2.07 (0.049) | 2.04 (0.045) | 1.88‡ (0.046) |
Week 12 | 1.66 (0.058) | 1.36 (0.054) | 1.21 (0.059) |
Change from baseline† | (−0.38) (0.055) | (−0.65)*** (0.056) | (−0.66)*** (0.054) |
PAC-QOL physical discomfort subscale score, mean (mean change from baseline)† | |||
Baseline | 2.40 (0.057) | 2.44 (0.054) | 2.27 (0.059) |
Week 12 | 1.86 (0.072) | 1.55 (0.067) | 1.33 (0.071) |
Change from baseline† | (−0.53) (0.067) | (−0.85)*** (0.070) | (−0.90)*** (0.079) |
PAC-QOL psychosocial discomfort subscale score, mean (mean change from baseline)† | |||
Baseline | 1.34 (0.062) | 1.22 (0.052) | 1.08‡ (0.052) |
Week 12 | 0.99 (0.063) | 0.79 (0.052) | 0.67 (0.054) |
Change from baseline† | (−0.32) (0.055) | (−0.40)* (0.053) | (−0.37)* (0.055) |
PAC-QOL worries and concerns subscale score, mean (mean change from baseline)† | |||
Baseline | 1.98 (0.062) | 2.00 (0.057) | 1.79 (0.061) |
Week 12 | 1.53 (0.066) | 1.26 (0.059) | 1.10 (0.070) |
Change from baseline† | (−0.41) (0.066) | (−0.72)*** (0.064) | (−0.71)*** (0.063) |
†Decreases reflect improvement. Asterisks indicate significant differences versus placebo. Levels of significance: *p⩽0.05; **p⩽0.01; ***p⩽0.001. ‡Baseline score was significantly different versus placebo (p⩽0.05). PAC-QOL, patient assessment of constipation quality of life; PRU, prucalopride; QOL, quality of life.