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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Constipation, Faecal Impaction

Intervention / Treatment
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* Drug: Polyethylene glycol with electrolytes
* Device: Polyethylene glycol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-only<br>Polyethylene glycol 4000 only (PEG-only). | Device: Polyethylene glycol<br>* 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.<br>* Other names: Onligol;|
| Active Comparator: PEG-EL<br>Polyethylene glycol 3350 with electrolytes (PEG-EL). | Drug: Polyethylene glycol with electrolytes<br>* 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.<br>* Other names: Movicol bambini;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-only laxative, chronic constipation, faecal impaction