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

Phase 3 Completed 88 enrolled Ipsen

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2005-04
Primary completion: 2008-05-20
Completion: 2008-05-20

Outcome

Met primary endpoint

paper with a least-squares mean difference of 0.36 stools/day [95% CI: 0.16 to 0.56]. PMID 24943105 ↗

paper PEG 4000 has superior efficacy to lactulose for the treatment of chronic constipation in young children PMID 24943105 ↗

Publications

Treepongkaruna S, Simakachorn N, Pienvichit P, Varavithya W, Tongpenyai Y, Garnier P, Mathiex-Fortunet H. A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children. BMC Pediatr. 2014 Jun 19;14:153. doi: 10.1186/1471-2431-14-153.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lactulose	Other / unclassified	3.3 g	Oral
Subject	PEG 4000	Unknown	8 g	Oral