NCT01875744

Polyethylene Glycol for Childhood Constipation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

Background: 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.

Detailed description

Children will be randomly assigned into 2 groups receiving polyethylene glycol 4000 (Forlax) with an initial dose of either 0.3g/kg, or 0.7 g / kg. 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

• Constipation

Interventions

Type	Name	Description
DRUG	Polyethylene glycol 4000

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-30
• First posted: 2013-06-12
• Last updated: 2025-07-22

Locations

1 site across 1 country: Poland