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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00255372
Other study ID # A-38-52072-012
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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