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

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00255372

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Bowel Movement Constipation Urinary Incontinence

Drug Information available for: Lactulose

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2006
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

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

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

Responsible Party:	Ipsen ( Axel Magis MD )
Study ID Numbers:	A-38-52072-012
Study First Received:	November 17, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00255372 History of Changes
Health Authority:	Thailand: Ethical Committee

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Therapeutic Uses
Gastrointestinal Agents

Constipation
Pharmacologic Actions
Lactulose

ClinicalTrials.gov processed this record on February 08, 2010