Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2013-06-30
2013-11-30
Brief Summary
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Aim:
Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children.
Study design:
Randomized, open-label trial.
Randomized, double-blind, placebo controlled trial.
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Detailed Description
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In case of ineffectiveness the dose of medication will be increased every two weeks with 0.2 g/kg. The indication for the increase in dose will be less than 3 bowel movements per week. For children with diarrhea defined as more than 3 loose stools for minimum 2 days or/and severe abdominal pain the macrogol dose of will be reduced every two weeks by 0.2 g/kg. The intervention will last 6 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Polyethylene glycol small dose
Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks
Polyethylene glycol 4000
Polyethylene glycol high dose
Polyethylene glycol 4000: 0.7g/kg for 6 weeks
Polyethylene glycol 4000
Interventions
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Polyethylene glycol 4000
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* functional constipation according to the Rome III Criteria
* consent of parents or guardians of the child to participate and study
Exclusion Criteria
1 Year
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Andrea Horvath-Stolarczyk
MD PhD
Principal Investigators
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Andrea Horvath, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Locations
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Dpt of Pediatrics The Medical University of Warsaw
Warsaw, , Poland
Countries
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References
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Dziechciarz P, Horvath A, Szajewska H. Polyethylene glycol 4000 for treatment of functional constipation in children. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):65-8. doi: 10.1097/MPG.0000000000000543.
Other Identifiers
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2/2013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2/2013
Identifier Type: -
Identifier Source: org_study_id
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