drugset / Trial / NCT01330381
Prucalopride in Pediatric Subjects With Functional Constipation
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-04-28
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
Outcome
Missed primary endpoint
registry Prucalopride vs Placebo; p = 0.9002; Cochran-Mantel-Haenszel NCT01330381 ↗
paper The proportion of responders was similar between groups (prucalopride, 17.0% and placebo, 17.8%). PMID 25239590 ↗
Publications
- Results Mugie SM, Korczowski B, Bodi P, Green A, Kerstens R, Ausma J, Ruth M, Levine A, Benninga MA. Prucalopride is no more effective than placebo for children with functional constipation. Gastroenterology. 2014 Dec;147(6):1285-95.e1. doi: 10.1053/j.gastro.2014.09.005. Epub 2014 Sep 16.
- van Schaick E, Benninga MA, Levine A, Magnusson M, Troy S. Development of a population pharmacokinetic model of prucalopride in children with functional constipation. Pharmacol Res Perspect. 2016 Jun 1;4(4):e00236. doi: 10.1002/prp2.236. eCollection 2016 Aug.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | PEG 4000 | Unknown | — | Oral |
| Subject | Prucalopride | Small molecule | 0.04 mg/kg | Oral |
| Subject | Prucalopride | Small molecule | 2 mg | Oral |