Table 4 QOL data derived from PAC-QOL questionnaire
PlaceboPRU 2 mgPRU 4 mg
Primary QOL endpoint
PAC-QOL satisfaction subscale score, mean (mean change from baseline)†
    Baseline3.17 (0.048)3.12 (0.054)3.08 (0.051)
    Week 122.85 (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 1234/207 (16.4%)69/206 (33.5%)***53/180 (29.4%)***
Overall PAC-QOL score, mean (mean change from baseline)†
    Baseline2.07 (0.049)2.04 (0.045)1.88‡ (0.046)
    Week 121.66 (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)†
    Baseline2.40 (0.057)2.44 (0.054)2.27 (0.059)
    Week 121.86 (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)†
    Baseline1.34 (0.062)1.22 (0.052)1.08‡ (0.052)
    Week 120.99 (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)†
    Baseline1.98 (0.062)2.00 (0.057)1.79 (0.061)
    Week 121.53 (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.