Conditions: Constipation
Keywords: Long term Constipation Digestive signs and symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 364
Healthy volunteers: no

Brief summary:
The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

Detailed description:
In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.

The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.

Adult subjects (≥18 to \<65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).

Arms:
arm 1: Placebo 2 mg tablet once daily before breakfast arm 2: Prucalopride 2 mg once daily before breakfast

Interventions: intervention 1: placebo intervention 2: prucalopride
Intervention descriptions: intervention 1: Placebo matching tablet 2 mg once daily before breakfast for 24 weeks intervention 2: Prucalopride 2 mg daily before breakfast

1 mg for subjects \>65 years; in case of insufficient response 2 mg at week 2 or week 4

Protocol document: