Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Phase 1

Completed

• Conditions: Constipation
• Interventions: Drug: prucalopride

• Registration Number: NCT01670669
• Lead Sponsor: Movetis

Brief 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.

Study Timeline

• Study Start: 1998-11
• Primary Completion: 1999-07
• Study Completion: 1999-07
• Study First Submitted: 2012-07-31
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-20
• Last Update Submitted: 2012-08-20
• Study First Posted: 2012-08-22
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prucalopride	prucalopride	0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

Primary Outcome Measures

Name	Time	Method
Adverse events		Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated.; Efficacy: reporting of bowel movements and its characteristics in a diary.
Efficacy		Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy variables: 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.	8 weeks