Maintenance Treatment for Children With Constipation
Constipation is a common problem among children. The majority of children suffering from constipation have no underlying disease. Although constipation has no basis in underlying disease, it often leads to a reduced quality of life of children who are on par with or worse than for children suffering from serious diseases such as cardiovascular and rheumatic diseases.
Despite the high frequency of constipation among children, little is known about the causes and treatment of constipation.
Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol junior has proven very effective and are therefore widely used in children as disimpaction and maintenance treatment. There is currently no research to prove the need for and length of maintenance treatment with laxative medications in children.
The purpose is to examining the effectiveness of maintenance treatment with Movicol. Additional til study will examine how the anal diameter change during a course of treatment and the degree to which it can be used as an indicator of treatment efficacy.
The study will test the following:
• What is the effect of maintenance treatment with PEG compared to placebo?
The results from this study are expected to form the basis for an evidence-based approach to the use of maintenance therapy and the use of ultrasound of the rectum in children with constipation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Maintenance Treatment With Polyethylene Glycol 3350 for Children With Constipation. A Randomized, Placebocontrolled Intervention Study|
- Treatment recovery [ Time Frame: ½ year ] [ Designated as safety issue: No ]Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.
- Usage of laxative [ Time Frame: ½ year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Active maintenance treatment||
Drug: Polyethylene glycol 3350
Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
|Placebo Comparator: Placebo maintenance treatment||
Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566409
|Kolding, Denmark, 6000|
|Contact: Line Modin, MD 61-386349 firstname.lastname@example.org|