Prucalopride in Pediatric Subjects With Functional Constipation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-28

Study Completion Date

2013-03-01

Brief Summary

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To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to \< 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.

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Detailed Description

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Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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prucalopride

drug

Group Type EXPERIMENTAL

prucalopride

Intervention Type DRUG

prucalopride

* subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
* subjects with weight \>50 kg: prucalopride 2 mg tablet once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching oral solution or oral tablets given once daily

PEG 4000

4-20g administered as an oral solution once daily

Group Type ACTIVE_COMPARATOR

PEG 4000

Intervention Type DRUG

Interventions

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prucalopride

prucalopride

* subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
* subjects with weight \>50 kg: prucalopride 2 mg tablet once daily

Intervention Type DRUG

Placebo

Matching oral solution or oral tablets given once daily

Intervention Type DRUG

PEG 4000

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Boys and girls, aged ≥ 6 months and \< 18 years.
2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.

Exclusion Criteria

1. Children with underlying GI abnormalities and causes for defecation disorders.
2. Constipation is thought to be drug-induced.
3. Subjects suffering from secondary causes of chronic constipation.

Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No