Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Summary

The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks. Hypothesis: Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.

Timeline

Start

1998-11

Primary completion

1999-07

Completion

1999-07

Publications

• Winter HS, Di Lorenzo C, Benninga MA, Gilger MA, Kearns GL, Hyman PE, Vandeplassche L, Ausma J, Hoppenbrouwers M. Oral prucalopride in children with functional constipation. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):197-203. doi: 10.1097/MPG.0b013e318292f9ea.

Drugs

Indications