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

Phase 3

Completed

• Conditions: Chronic Constipation
• Interventions: Drug: Lactulose active and Lactulose placebo; Drug: PEG 4000 (Forlax®)

• Registration Number: NCT00255372
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-18
• Primary Completion: 2008-05-20
• Study Completion: 2008-05-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Lactulose active and Lactulose placebo	-
1	PEG 4000 (Forlax®)	-

Primary Outcome Measures

Name	Time	Method
Bowel movement frequency	week 4

Secondary Outcome Measures

Name	Time	Method
Subjective symptoms associated with defecation.	At every visit

Trial Locations

Locations (2)

Ramathibodi Hospital, Mahidol University,; 🇹🇭 Bangkok, Thailand

Maharat Nakhon Ratchasima Hospital; 🇹🇭 Nakhon Ratchasima, Thailand