To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
Information source: Ipsen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Constipation
Intervention: PEG 4000 (Forlax®) (Drug); Lactulose active and Lactulose placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Axel Magis, MD, Study Director, Affiliation: Ipsen
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Bowel movement frequency
Secondary outcome: Subjective symptoms associated with defecation.
Eligibility
Minimum age: 12 Months.
Maximum age: 36 Months.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Ramathibodi Hospital, Mahidol University,, Bangkok 10400, Thailand
Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima 30000, Thailand
Additional Information
Starting date: April 2005
Ending date: December 2006
Last updated: June 3, 2008
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