Conditions: Functional Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 215
Healthy volunteers: no

Brief summary:
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to \< 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.

Detailed description:

Arms:
arm 1: drug arm 2: None arm 3: 4-20g administered as an oral solution once daily

Interventions: intervention 1: prucalopride intervention 2: Placebo intervention 3: PEG 4000
Intervention descriptions: intervention 1: prucalopride

* subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
* subjects with weight \>50 kg: prucalopride 2 mg tablet once daily intervention 2: Matching oral solution or oral tablets given once daily intervention 3: None

Protocol document: