Prucalopride in Paediatric Subjects, With Functional Faecal Retention

• Status: Completed
• Trial end date: 1999-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

• Subject completed the PRU-USA-12 pharmacokinetic trial

• Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)

• Written informed consent, signed by the subject's legal guardian and by the investigator

• Subject assent documented in the form of a note-to-file in the subject's source documentation

Exclusion Criteria:

• No exclusion criteria