MedTrace Logo

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

NCT00255372 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-04-24

No results posted yet for this study

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.

Conditions

  • Chronic Constipation

Interventions

DRUG

PEG 4000 (Forlax®)

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

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.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-05-20
Completion
2008-05-20

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00255372 on ClinicalTrials.gov