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

Constipation Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674166
• Other study ID #: PRU-USA-12
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2012
• Last updated: August 27, 2012
• Start date: November 1998
• Est. completion date: May 1999

Study information

• Verified date: June 2012
• Source: Movetis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 1999
• Est. primary completion date: May 1999
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Movetis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Secondary	Secondary efficacy variables: safety and tolerability of a single dose of prucalopride 0.03 mg/kg given to paediatric subjects with FFR.			No