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

Primary Purpose

Constipation, Faecal Impaction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Polyethylene glycol with electrolytes
Polyethylene glycol
Sponsored by
Azienda Policlinico Umberto I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring chronic constipation, faecal impaction, PEG-only laxative

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PEG-only

    PEG-EL

    Arm Description

    Polyethylene glycol 4000 only (PEG-only).

    Polyethylene glycol 3350 with electrolytes (PEG-EL).

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Clinical tolerability
    Recording of all Adverse Events (AEs) occurred during the study
    Acceptability
    Palatability and easy of taking the solution evaluated by a 5-points scale
    Compliance
    Percentage of patients who took more than 80% of the prescribed dose
    Efficacy
    Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card

    Full Information

    First Posted
    May 4, 2012
    Last Updated
    May 4, 2012
    Sponsor
    Azienda Policlinico Umberto I
    Collaborators
    Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01592734
    Brief Title
    Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Policlinico Umberto I
    Collaborators
    Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation, Faecal Impaction
    Keywords
    chronic constipation, faecal impaction, PEG-only laxative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEG-only
    Arm Type
    Experimental
    Arm Description
    Polyethylene glycol 4000 only (PEG-only).
    Arm Title
    PEG-EL
    Arm Type
    Active Comparator
    Arm Description
    Polyethylene glycol 3350 with electrolytes (PEG-EL).
    Intervention Type
    Drug
    Intervention Name(s)
    Polyethylene glycol with electrolytes
    Other Intervention Name(s)
    Movicol bambini
    Intervention Description
    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
    Device
    Intervention Name(s)
    Polyethylene glycol
    Other Intervention Name(s)
    Onligol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Efficacy
    Description
    Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card
    Time Frame
    4 weeks of observation
    Title
    Efficacy
    Description
    Feacal impaction resolution
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Clinical tolerability
    Description
    Recording of all Adverse Events (AEs) occurred during the study
    Time Frame
    4 weeks of observation
    Title
    Acceptability
    Description
    Palatability and easy of taking the solution evaluated by a 5-points scale
    Time Frame
    4 weeks of observation
    Title
    Compliance
    Description
    Percentage of patients who took more than 80% of the prescribed dose
    Time Frame
    4 weeks
    Title
    Efficacy
    Description
    Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23152962
    Citation
    Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.
    Results Reference
    derived

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

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