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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction

NCT06349031

Functional Constipation Fecal Impaction Constipation - Functional +2 more

NOT_YET_RECRUITING PHASE4

The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation

NCT06357897

Functional Constipation

NOT_YET_RECRUITING NA

Maintenance Treatment for Children With Constipation

NCT01566409

Constipation

COMPLETED NA

PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

NCT00153114

Constipation

COMPLETED PHASE4

Polyethylene Glycol for Childhood Constipation

NCT01875744

Constipation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Constipation Faecal Impaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEG-only

Polyethylene glycol 4000 only (PEG-only).

Group Type EXPERIMENTAL

Polyethylene glycol

Intervention Type DEVICE

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.

PEG-EL

Polyethylene glycol 3350 with electrolytes (PEG-EL).

Group Type ACTIVE_COMPARATOR

Polyethylene glycol with electrolytes

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Movicol bambini Onligol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No