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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01592734
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : May 7, 2012
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I

Brief 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

Condition or disease Intervention/treatment Phase
Constipation Faecal Impaction Drug: Polyethylene glycol with electrolytes Device: Polyethylene glycol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Giovanni Di Nardo, MD, Azienda Policlinico Umberto I Identifier: NCT01592734     History of Changes
Other Study ID Numbers: PEG-P1
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Fecal Impaction
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Agents