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Completed

NCT Number: NCT01592734

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

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

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Key information

Conditions

Constipation Digestive System Diseases Faecal Impaction Fecal Impaction Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene glycol with electrolytes

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.

Other names: Movicol bambini

Polyethylene glycol

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.

Other names: Onligol

Primary outcomes

  1. Efficacy

    Time frame: 4 weeks of observation

    Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card

  2. Efficacy

    Time frame: 7 days

    Feacal impaction resolution

Secondary outcomes

  1. Clinical tolerability

    Time frame: 4 weeks of observation

    Recording of all Adverse Events (AEs) occurred during the study

  2. Acceptability

    Time frame: 4 weeks of observation

    Palatability and easy of taking the solution evaluated by a 5-points scale

  3. Compliance

    Time frame: 4 weeks

    Percentage of patients who took more than 80% of the prescribed dose

  4. Efficacy

    Time frame: 4 weeks

    Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Collaborators

  • Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 7, 2012
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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