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

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT01592734
First received: May 4, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Constipation
Faecal Impaction
 Drug: Polyethylene glycol with electrolytes
Device: Polyethylene glycol
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Policlinico Umberto I:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 4 weeks of observation ] [ Designated as safety issue: No ]
    Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card

  • Efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Feacal impaction resolution


Secondary Outcome Measures:
  • Clinical tolerability [ Time Frame: 4 weeks of observation ] [ Designated as safety issue: Yes ]
    Recording of all Adverse Events (AEs) occurred during the study

  • Acceptability [ Time Frame: 4 weeks of observation ] [ Designated as safety issue: No ]
    Palatability and easy of taking the solution evaluated by a 5-points scale

  • Compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Percentage of patients who took more than 80% of the prescribed dose

  • Efficacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card


Enrollment: 96
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Movicol bambini

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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Azienda Policlinico Umberto I

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01592734     History of Changes
Other Study ID Numbers: PEG-P1
Study First Received: May 4, 2012
Last Updated: May 4, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Policlinico Umberto I:
chronic constipation
faecal impaction
PEG-only laxative

Additional relevant MeSH terms:
Constipation
Fecal Impaction
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Laxatives
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013