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

• Status: Completed
• Trial end date: 2008-05-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Lactulose

Criteria

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