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

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.

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Key information

Conditions

Chronic Constipation

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ramathibodi Hospital, Mahidol University,, Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG 4000 (Forlax®)

Drug

Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.

Lactulose active and Lactulose placebo

Drug

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.

Primary outcomes

Bowel movement frequency

Time frame: week 4

Secondary outcomes

Subjective symptoms associated with defecation.

Time frame: At every visit

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Nov 18, 2005
Registry last updated: Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed