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

Phase 4

Completed

• Conditions: Constipation; Faecal Impaction
• Interventions: Device: Polyethylene glycol; Drug: Polyethylene glycol with electrolytes

• Registration Number: NCT01592734
• Lead Sponsor: Azienda Policlinico Umberto I

Brief 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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-04
• Last Update Submitted: 2012-05-04
• Study First Posted: 2012-05-07
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination

Exclusion Criteria

• children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities;
• Children receiving medication influencing gastrointestinal motility;
• Children with suspected gastrointestinal obstruction or stenosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-only	Polyethylene glycol	Polyethylene glycol 4000 only (PEG-only).
PEG-EL	Polyethylene glycol with electrolytes	Polyethylene glycol 3350 with electrolytes (PEG-EL).

Primary Outcome Measures

Name	Time	Method
Efficacy	7 days	Feacal impaction resolution

Secondary Outcome Measures

Name	Time	Method
Acceptability	4 weeks of observation	Palatability and easy of taking the solution evaluated by a 5-points scale
Efficacy	4 weeks	Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card
Clinical tolerability	4 weeks of observation	Recording of all Adverse Events (AEs) occurred during the study
Compliance	4 weeks	Percentage of patients who took more than 80% of the prescribed dose