Trial consisting of an 8-week double-blind placebo-controlled part to evaluate efficacy, safety, tolerability and pharmacokinetics of prucalopride in paediatric subjects with functional constipation, aged =6 months to <18 years, followed by a 16-week open-label comparator (PEG) controlled part, to document safety and tolerability up to 24 weeks - Not applicable

INTERVENTION: Trade Name: Resolor® Product Name: Resolor Product Code: M0001 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: PRUCALOPRIDE CAS Number: 179474818 Current Sponsor code: M0001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: prucalopride oral solution Product Code: M0001 Pharmaceutical Form: Oral solution INN or Proposed INN: PRUCALOPRIDE CAS Number: 179474818 Current Sponsor code: M0001 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.4‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Trade Name: Forlax® Product Name: Forlax Pharmaceutical Form: Powder for oral solution CAS Number: 8000014439 Other descriptive name: MACROGOL 4000 Concentration unit: g gram(s) Concentration type: equal Concentration number: 10‐ Trade Name: Forlax Junior® Product Name: Forlax Junior Pharmaceutical Form: Powder for oral solution CAS Number: 8000014439 Other descriptive name: MACROGOL 4000 Concentration unit: g gram(s) Concentration type: equal Concentration number: 4‐ CONDITION: Functional constipation in paediatric subjects ; MedDRA version: 13.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 ‐ Gastrointestinal disorders PRIMARY OUTCOME: Main Objective: 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. Primary end point(s): The proportion of responders, defined as subjects with an average spontaneous‡ defecation frequency of =3 times/week AND an average number of = 1 episode of faecal incontinence/2 weeks# (as calculated over week 5 to 8 of the double‐blind treatment phase).; ‡A spontaneous bowel movement (SBM) is defined as a non‐laxative induced BM, i.e. not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.; #Faecal incontinence will only be taken into account in children after acquisition of toileting skills.; Secondary Objective: 1. Investigation of the individual symptoms defined by the Rome III criteria: bowel frequency, faecal incontinence, retentive posturing or excessive volitional stool retention, defecation pain, stool consistency, occurrence of large diameter stools. In addition use of rescue medication, abdominal pain and toilet training*.; 2. Pharmacokinetics: sparse blood sampling at single dose and steady state to enable population pharmacokinetic modelling. ; 3. Safety and tolerability: evaluation of prucalopride treatment up to 24 weeks.; *Only for older children after acquisition of toileting skills (as standard of care).; INCLUSION CRITERIA: 1. Boys and girls, aged =6 months to <18 years 2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria in the following way: Subjects should have =2 spontaneous‡ defecations per week together with at least 1 out of 5 of the following symptoms during one month (for <4 years of age) or two months (for =4 years of age) prior to the selection: 1) at least one episode of faecal incontinence per week (after the acquisition of toileting skills), 2) history of retentive posturing or excessive volitional stool retention, 3) history of painful or hard bowel movements (BMs), 4) presence of large faecal mass in the rectum, and 5) history of large diameter stools. 3. Subject and/or parent(s) or legally authorised representative agree to stop laxative use and agree to use the rescue medication according to the rescue rule. 4. Subject and/or parent(s) or legally authorised representative agree to stop the use of disallo