Prucalopride in Paediatric Subjects, With Functional Faecal Retention
Status:
Completed
Trial end date:
1999-07-01
Target enrollment:
Participant gender:
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.