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

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255372
• Other study ID #: A-38-52072-012
• Status: Completed
• Phase: Phase 3
• Start date: April 2005
• Est. completion date: May 20, 2008

Study information

• Verified date: April 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 20, 2008
• Est. primary completion date: May 20, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• PEG 4000 (Forlax®)
Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
• 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.

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital, Mahidol University,	Bangkok
Thailand	Maharat Nakhon Ratchasima Hospital	Nakhon Ratchasima

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel movement frequency		week 4
Secondary	Subjective symptoms associated with defecation.		At every visit