To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.

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

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-05-20

Brief Summary

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The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.

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Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

PEG 4000 (Forlax®)

Intervention Type DRUG

Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.

2

Group Type ACTIVE_COMPARATOR

Lactulose active and Lactulose placebo

Intervention Type DRUG

Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.

Interventions

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PEG 4000 (Forlax®)

Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.

Intervention Type DRUG

Lactulose active and Lactulose placebo

Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis)
* Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy