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

Primary Purpose

Constipation

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

prucalopride

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

4 Years - 12 Years (Child)

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prucalopride

Arm Description

single dose 0.03 mg/kg prucalopride open label

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT01674166

First Posted

August 24, 2012

Last Updated

August 27, 2012

Sponsor

Movetis

1. Study Identification

Unique Protocol Identification Number

NCT01674166

Brief Title

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

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).

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

November 1998 (undefined)

Primary Completion Date

May 1999 (Actual)

Study Completion Date

May 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Movetis

4. Oversight

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prucalopride

Arm Type

Experimental

Arm Description

single dose 0.03 mg/kg prucalopride open label

Intervention Type

Drug

Intervention Name(s)

prucalopride

Intervention Description

single dose 0.03 mg/kg prucalopride open label

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harald Winter, M.D.

Organizational Affiliation

Massachusetts General Hospital for Children, Boston, Massachusetts, USA

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

23535761

Citation

Winter HS, Di Lorenzo C, Benninga MA, Gilger MA, Kearns GL, Hyman PE, Vandeplassche L, Ausma J, Hoppenbrouwers M. Oral prucalopride in children with functional constipation. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):197-203. doi: 10.1097/MPG.0b013e318292f9ea.

Results Reference

derived

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

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