Prucalopride in Paediatric Subjects, With Functional Faecal Retention

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–12 year

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prucalopride

Drug

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

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

Sponsors and collaborators

Lead sponsor

Movetis

Industry

Registry information

Official study title

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.

Important dates

Study start: 1998
Primary completion: 1999
Study completion: 1999
First posted: Aug 22, 2012
Registry last updated: Aug 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed