Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Movetis37 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Constipation

Interventions

prucaloprideDRUG

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

Eligibility

Min age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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