NCT01592734

Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children

Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children. A Controlled Double Blind Randomized Study vs a Standard PEG-EL Laxative

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation

Detailed description

Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation. Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools. It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.

Conditions

• Constipation
• Faecal Impaction

Interventions

Type	Name	Description
DRUG	Polyethylene glycol with electrolytes	Constipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks. Faecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days.
DEVICE	Polyethylene glycol	Constipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children \> 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks. Faecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2012-05-07
• Last updated: 2012-05-07