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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592734
• Other study ID #: PEG-P1
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2012
• Last updated: May 4, 2012
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Faecal Impaction
• Fecal Impaction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I	Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Efficacy	Feacal impaction resolution	7 days	No
Secondary	Clinical tolerability	Recording of all Adverse Events (AEs) occurred during the study	4 weeks of observation	Yes
Secondary	Acceptability	Palatability and easy of taking the solution evaluated by a 5-points scale	4 weeks of observation	No
Secondary	Compliance	Percentage of patients who took more than 80% of the prescribed dose	4 weeks	No
Secondary	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	No