Table 1.
Description of the six randomized, double-blind, placebo-controlled clinical trials
| Study ID | Number of study centers and location | Trial dates | Daily drug dosea | Number of patients assigned to each treatment arm | Duration, weeks | Sex, men/women | Median age, years (range) |
|---|---|---|---|---|---|---|---|
| SPD555-302 [23] | 66 Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Poland, Romania, Netherlands, UK |
September 23, 2010–October 25, 2013 | Prucalopride 2 mg or placebo | Prucalopride 2 mg: 177 Prucalopride 1 mg: 80 (65 increased to 2 mg) Placebo: 181 |
12 | 370/0 | 61.0 (18–91) |
| SPD555-401 [22] | 50 Belgium, Czech Republic, Hungary, Italy, Poland, Romania, Slovakia, Spain, Sweden |
April 6, 2011–December 19, 2012 | Prucalopride 2 mg or placebo | Prucalopride 2 mg: 171 Prucalopride 1 mg: 35 (28 increased to 2 mg) Placebo: 169 |
24 | 53/308 | 50.0 (18–91) |
| PRU-CRC-3001 [21] | 46 Australia, China, Korea, Taiwan, Thailand |
April 2, 2010–March 9, 2011 | Prucalopride 2 mg or placebo | Prucalopride 2 mg: 249 Placebo: 252 |
12 | 51/450 | 43.0 (18–65) |
| PRU-USA-13 [20] | 41 USA |
March 18, 1998–May 4, 1999 | Prucalopride 2 mg or 4 mg, or placebo | Prucalopride 2 mg: 214 Prucalopride 4 mg: 215b Placebo: 212 |
12 | 86/555 | 46.0 (18–95) |
| PRU-USA-11 [18] | 38 USA |
April 2, 1998–May 24, 1999 | Prucalopride 2 mg or 4 mg, or placebo | Prucalopride 2 mg: 190 Prucalopride 4 mg: 204b Placebo: 193 |
12 | 75/545 | 47.5 (18–85) |
| PRU-INT-6 [19] | 63 Australia, Belgium, Canada, Netherlands, Norway, South Africa, Sweden, UK |
March 13, 1998–July 19, 1999 | Prucalopride 2 mg or 4 mg, or placebo | Prucalopride 2 mg: 236 Prucalopride 4 mg: 238b Placebo: 240 |
12 | 66/650 | 43.0 (17–89) |
The primary endpoint for each trial was the proportion of patients with ≥3 SCBMs/week over the duration of the trial
SCBM spontaneous complete bowel movement
aPrucalopride and placebo administered as oral tablets
bPatients receiving prucalopride 4 mg were not included in the integrated analysis