Prucalopride in Paediatric Subjects, With Functional Faecal Retention

August 20, 2012 updated by: Movetis

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (CHILD)

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: prucalopride
0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution
Drug: prucalopride
0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Movetis

Investigators

  • Principal Investigator: Harald Winter, M.D., Massachusetts General Hospital for Children, Boston, Massachusetts, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (ACTUAL)

July 1, 1999

Study Completion (ACTUAL)

July 1, 1999

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (ESTIMATE)

August 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2012

Last Update Submitted That Met QC Criteria

August 20, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRU-USA-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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