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

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

Study Overview

• Status: Completed
• Conditions: Constipation; Faecal Impaction
• Intervention / Treatment: Device: Polyethylene glycol; Drug: Polyethylene glycol with electrolytes

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-only; Polyethylene glycol 4000 only (PEG-only).	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.; Other Names: Onligol
Active Comparator: PEG-EL; Polyethylene glycol 3350 with electrolytes (PEG-EL).	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.; Other Names: Movicol bambini

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card	4 weeks of observation
Efficacy	Feacal impaction resolution	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Policlinico Umberto I
• Collaborators: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Publications and helpful links

General Publications

• Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 4, 2012
• First Posted (Estimate): May 7, 2012

Study Record Updates

• Last Update Posted (Estimate): May 7, 2012
• Last Update Submitted That Met QC Criteria: May 4, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: chronic constipation; faecal impaction; PEG-only laxative
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Constipation; Fecal Impaction
• Other Study ID Numbers: PEG-P1