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

NCT01592734 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2012-05-07

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

    collaborator OTHER

  • Azienda Policlinico Umberto I

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592734 on ClinicalTrials.gov