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

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT00255372

Collaborator

(none)

Enrollment

Locations

Arms

37.6

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Constipation	Drug: PEG 4000 (Forlax®) Drug: Lactulose active and Lactulose placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2005

Actual Primary Completion Date :

May 20, 2008

Actual Study Completion Date :

May 20, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: PEG 4000 (Forlax®) Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
Active Comparator: 2	Drug: 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.

Arm

Intervention/Treatment

Experimental: 1

Drug: PEG 4000 (Forlax®)

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

Active Comparator: 2

Drug: 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.

Outcome Measures

Primary Outcome Measures

Bowel movement frequency [week 4]

Secondary Outcome Measures

Subjective symptoms associated with defecation. [At every visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 36 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ramathibodi Hospital, Mahidol University,	Bangkok		Thailand	10400
2	Maharat Nakhon Ratchasima Hospital	Nakhon Ratchasima		Thailand	30000

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT00255372

Other Study ID Numbers:

A-38-52072-012

First Posted:

Nov 18, 2005

Last Update Posted:

Apr 24, 2020

Last Verified:

Apr 1, 2020

Additional relevant MeSH terms:

Constipation

Lactulose

Study Results

No Results Posted as of Apr 24, 2020