Table 1.

Pivotal clinical trials.

Reference	Study design	Study duration	Sample size	Primary endpoint: ⩾3 SCBM/week (proportion of patients)	Secondary endpoint: ↑ ⩾1 SCBM (proportion of patients)
Camilleri et al., 200837	2 mg or 4 mg daily versus placebo	12 weeks	620	Week 12: 30.9%, * 28.4% * versus 12%	Week 12: 47.3%, * 46.6% * versus 25.8%
Tack et al., 200938	2 mg or 4 mg daily versus placebo	12 weeks	713	Week 12: 19.5%, * 23.6% * versus 9.6%	Week 12: 38.1%, * 44.1% * versus 20.9%
Quigley et al., 200939	2 mg or 4 mg daily versus placebo	12 weeks	641	Week 12: 23.9%, * 23.5% * versus 12.1%	Week 12: 42.6%, * 46.6% * versus 27.5%
Müller-Lissner et al., 201040	1 mg, 2 mg or 4 mg daily versus placebo	4 weeks	300	Week 1: 42.1%, 43.8%, 48.7% * versus 26.1% Week 4: 43.7%, 37.5%, 30.6% versus 24.6%	Week 1: 61.8, * 63.0, * 68.4% * versus 40.6 Week 4: 59.2%, * 48.6%, 45.8% versus 33.8%
Ke et al., 201241	2 mg versus placebo	12 weeks	501	Week 12: 33.3% * versus 10.3%	Week 4: 34.5% * versus 11.1%
Yiannakou et al., 201542	2 mg versus placebo	12 weeks	374	Week 12: 37.9 * versus 17.7%	Week 12: 27.7% * versus 12.2%
Piessevaux et al., 201543	2 mg versus placebo	24 weeks	361	Week 12: 25.1% versus 20.1% Week 24: 25.1% versus 20.7%	Week 24: 48% versus 42%

Prucalopride results in bold. * indicates that the result for that prucalopride dose was significantly superior to placebo.

SCBM, spontaneous complete bowel movement.