NCT00255372

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

Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-blind, Lactulose Controlled Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	PEG 4000 (Forlax®)	Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
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.

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-05-20
• Completion: 2008-05-20
• First posted: 2005-11-18
• Last updated: 2020-04-24

Locations

2 sites across 1 country: Thailand