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Prucalopride in Paediatric Subjects, With Functional Faecal Retention

NCT ID: NCT01670669

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

1999-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prucalopride

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

Group Type ACTIVE_COMPARATOR

prucalopride

Intervention Type DRUG

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

Interventions

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prucalopride

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Movetis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harald Winter, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital for Children, Boston, Massachusetts, USA

References

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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.

Reference Type DERIVED
PMID: 23535761 (View on PubMed)

Other Identifiers

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PRU-USA-24

Identifier Type: -

Identifier Source: org_study_id