| Placebo N = 240 | PRU 2 mg N = 236 | PRU 4 mg N = 237 | |
| Primary efficacy endpoint | |||
| Patients with an average of ⩾3 SCBM per week, n/N (%) | |||
| Run-in | 2/239 (0.8) | 2/236 (0.8) | 3/237 (1.3) |
| Weeks 1–12 | 23/240 (9.6) | 46/236 (19.5)** | 56/237 (23.6)*** |
| Secondary efficacy endpoints | |||
| Patients with an average increase of ⩾1 SCBM per week, n/N (%) | |||
| Weeks 1–12 | 49/234 (20.9) | 86/226 (38.1)*** | 94/213 (44.1)*** |
| Average number of SCBM per week, mean (mean change from baseline) | |||
| Baseline | 0.4 | 0.4 | 0.5 |
| Weeks 1–12 | 1.0 (0.5) | 1.6 (1.2)*** | 1.9 (1.4)*** |
| Percentage of BM with normal consistency, mean (mean change from baseline) | |||
| Baseline | 21.4 | 23.2 | 23.9 |
| Weeks 1–12 | 33.7 (12.6) | 40.0 (17.4)* | 41.6 (16.6)** |
| Percentage of BM with no straining, mean (mean change from baseline) | |||
| Baseline | 17.8 | 15.5 | 17.9 |
| Weeks 1–12 | 14.8 (−3.5) | 16.4 (1.0) | 19.6 (1.3)* |
| Percentage of BM with a sensation of complete evacuation, mean (mean change from baseline) | |||
| Baseline | 17.7 | 13.9 | 21.4 |
| Weeks 1–12 | 23.8 (5.9) | 25.5 (11.7)* | 35.7 (14.3)*** |
| Time to first SCBM after first intake of trial medication, days | |||
| Median time | 20.5 | 4.7*** | 2.1*** |
| Average number of days with laxative use (bisacodyl (Dulcolax) or enema)/week, mean (mean change from baseline) | |||
| Baseline | 1.0 | 0.8 | 0.8 |
| Weeks 1–12 | 0.8 (−0.2) | 0.4 (−0.4)*** | 0.5 (−0.3)*** |
| Patient assessment of constipation severity, mean (mean change from baseline) | |||
| Baseline | 2.74 | 2.66 | 2.72 |
| Week 12 | 2.39 (−0.31) | 1.90 (−0.76)*** | 1.82 (−0.92)*** |
| Patients rating their treatment as quite or extremely effective, n/N (%) | |||
| Week 12 | 39/209 (18.7) | 71/205 (34.6)*** | 65/180 (36.1)*** |
Asterisks indicate significant differences versus placebo. Levels of significance: *p⩽0.05; **p⩽0.01; ***p⩽0.001. BM, bowel movement; PRU, prucalopride; SCBM, spontaneous complete bowel movements.