NCT01670669

Prucalopride in Paediatric Subjects, With Functional Faecal Retention

An Open-label Follow-up Study of 0.01 mg/kg/Day to 0.03 mg/kg/Day Prucalopride (R108512) Oral Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR), Who Participated in the PRU-USA-12.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Movetis · Industry
• Sex: —
• Age: 4 Years – 12 Years
• Healthy volunteers: —

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.

Detailed description

This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial, usually within the previous week. Evaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks. The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

Timeline

• Start date: 1998-11-01
• Primary completion: 1999-07-01
• Completion: 1999-07-01
• First posted: 2012-08-22
• Last updated: 2012-08-22