Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention

August 27, 2012 updated by: Movetis

A Single-dose Pharmacokinetic Trial of 0.03 mg/kg R108512 Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR).

The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.

Hypothesis:

Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicentre, open-label, single-dose pharmacokinetic trial. A minimum of 24 paediatric subjects (aged ≥ 4 to ≤ 12 years) with functional faecal retention (FFR) were administered a single dose of prucalopride in oral solution.

All subjects who qualified to enter the trial received a single dose of 0.03 mg/kg prucalopride oral solution at Hour 0 on Day 1. One blood sample was drawn prior to dosing, and 13 samples were drawn over the 72-hour interval following the single dose or prucalopride. Urine was collected quantitatively for the first 24 hours. Plasma prepared from blood samples and urine samples were assayed for prucalopride concentrations. Safety was monitored over the 72-hour interval following the dose of trial medication.

Study Type

Interventional

Enrollment (Actual)

38

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:

  • Subjects with a confirmed diagnosis of FFR, defined as a minimum 2-month history of faecal impaction, plus at least one of the following:

    • < 3 bowel movements per week at the toilet;
    • A history of soiling;
  • Male and female subjects ≥ 4 to ≤ 12 years of age, with a Tanner stage 1 of 2 or less;
  • Weight-height proportionality for age within the 5th and 95th percentile;
  • Written informed consent, signed by the subject's legal guardian and by the investigator, and;
  • Subject assent documented in the form of a note-to-file in the subject's source documentation.

Exclusion Criteria:

  • Requirement for any medication during the period of the trial;
  • Evidence by examination or laboratory tests of abnormal growth;
  • An abnormal neurologic examination;
  • Cystic fibrosis;
  • History of, or current anorectal malformations;
  • Diagnosed chromosomal abnormalities (e.g., Down's Syndrome);
  • Disease state or surgery known to significantly affect the gastrointestinal absorption of drugs, or the assessment of the trial drug's effect;
  • Any history, clinical and/or biochemical evidence of clinically significant renal or liver disease or cirrhosis;
  • Clinically significant anaemia;
  • Use of any investigational drug within the 4-week period prior to administration of trial medication.

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
EXPERIMENTAL: prucalopride
single dose 0.03 mg/kg prucalopride open label
Drug: prucalopride
single dose 0.03 mg/kg prucalopride open label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.

Secondary Outcome Measures

Outcome Measure
Secondary efficacy variables: safety and tolerability of a single dose of prucalopride 0.03 mg/kg given to paediatric subjects with FFR.

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)

May 1, 1999

Study Completion (ACTUAL)

May 1, 1999

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 28, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRU-USA-12

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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