Trial consisting of an 8-week part to evaluate potency, side effects, tolerability and blood levels of prucalopride in children with functional constipation, aged =6 months to <18 years, followed by a 16-week part to assess the side effects and tolerability of prucalopride in comparison to PEG.
- Conditions
- Functional constipation in paediatric subjectsMedDRA version: 14.1Level: PTClassification code 10010774Term: ConstipationSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2010-022402-40-BE
- Lead Sponsor
- Shire-Movetis NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
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 disallowed medication.
‡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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Children with underlying GI abnormalities and causes for defecation disorders such as Hirschsprung’s disease, spina bifida occulta, cystic fibrosis, GI malformations, or significant developmental delays that are associated with musculoskeletal or neurological conditions affecting the GI tract.
2. Children who are breast fed.
3. Subjects suffering from secondary causes of chronic constipation, e.g.: Endocrine disorders, Metabolic disorders, Neurological disorders, Organic disorders, Surgery, Hernia, Autoimmune disorders.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method