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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00255372
First received: November 17, 2005
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Chronic Constipation
Drug: PEG 4000 (Forlax®)
Drug: Lactulose active and Lactulose placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Bowel movement frequency [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective symptoms associated with defecation. [ Time Frame: At every visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2005
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255372

Locations
Thailand
Ramathibodi Hospital, Mahidol University,
Bangkok, Thailand, 10400
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, Thailand, 30000
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Axel Magis, MD Ipsen
  More Information

No publications provided by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Axel Magis MD, Ipsen
ClinicalTrials.gov Identifier: NCT00255372     History of Changes
Other Study ID Numbers: A-38-52072-012
Study First Received: November 17, 2005
Last Updated: June 3, 2008
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Constipation
Fecal Incontinence
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014