Status:
COMPLETED
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
Lead Sponsor:
Ipsen
Conditions:
Chronic Constipation
Eligibility:
All Genders
12-36 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Organic bowel diseases
- Suspected GI obstruction
- History of GI surgery
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2008
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00255372
Start Date
April 1 2005
End Date
May 20 2008
Last Update
April 24 2020
Active Locations (2)
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1
Ramathibodi Hospital, Mahidol University,
Bangkok, Thailand, 10400
2
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, Thailand, 30000