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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation

Treatments: Drug: PEG 4000 (Forlax®); Drug: Lactulose active and Lactulose placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00255372

A-38-52072-012

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Organic bowel diseases
• Suspected GI obstruction
• History of GI surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: PEG 4000 (Forlax®)

2

Active Comparator group

Treatment:

Drug: Lactulose active and Lactulose placebo