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
- Conditions
- constipationobstruction10017977
- Registration Number
- NL-OMON36457
- Lead Sponsor
- Movetis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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 criteria3 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.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy is evaluated by the proportion of responders in the prucalopride vs.<br /><br>placebo arm.<br /><br>A subject is defined as a responder when the average spontaneous* defecation<br /><br>frequency is *3 times/week AND the average number of faecal incontinence<br /><br>episodes per 2 weeks is * 1 episode# (as calculated over week 5 to 8 of the<br /><br>double-blind treatment phase).<br /><br><br /><br>*A spontaneous bowel movement (SBM) is defined as a non-laxative induced BM,<br /><br>i.e. not preceded within a period of 24 hours by the intake of a laxative agent<br /><br>or by the use of an enema.<br /><br>#Faecal incontinence will only be taken into account in children after<br /><br>acquisition of toileting skills.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Het aantal patiënten met een gemiddelde spontane defecatiefrequentie van * 3<br /><br>maal/week<br /><br>* Het aantal episodes van fecale incontinentie per week<br /><br>* Wekelijkse frequentie van retentieve houding of overmatig, wilskrachtig<br /><br>ophouden van stoelgang<br /><br>* Frequentie van defecatiepijn (6-puntsschaal; alleen bij patiënten van 3 jaar<br /><br>of ouder)<br /><br>* Consistentie van de stoelgang per week (4-puntsschaal voor kinderen die een<br /><br>luier dragen of 7-punts Bristol-schaal voor kinderen die geen luier dragen)<br /><br>* Wekelijks aantal grote stoelgangen</p><br>