Polyethylene Glycol for Childhood Constipation

November 1, 2013 updated by: Andrea Horvath-Stolarczyk, Medical University of Warsaw

Background:

Aim:

Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children.

Study design:

Randomized, open-label trial.

Randomized, double-blind, placebo controlled trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Children will be randomly assigned into 2 groups receiving polyethylene glycol 4000 (Forlax) with an initial dose of either 0.3g/kg, or 0.7 g / kg.

In case of ineffectiveness the dose of medication will be increased every two weeks with 0.2 g/kg. The indication for the increase in dose will be less than 3 bowel movements per week. For children with diarrhea defined as more than 3 loose stools for minimum 2 days or/and severe abdominal pain the macrogol dose of will be reduced every two weeks by 0.2 g/kg. The intervention will last 6 weeks.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-184
        • Recruiting
        • Dpt of Pediatrics The Medical University of Warsaw
        • Principal Investigator:
          • Piotr Dziechciarz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 1 - 18 age
  • functional constipation according to the Rome III Criteria
  • consent of parents or guardians of the child to participate and study

Exclusion Criteria:

  • organic cause constipation (including surgeries within the lower GI tract)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyethylene glycol small dose
Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks
Drug: Polyethylene glycol 4000
Other Names:
  • Forlax
Active Comparator: Polyethylene glycol high dose
Polyethylene glycol 4000: 0.7g/kg for 6 weeks
Drug: Polyethylene glycol 4000
Other Names:
  • Forlax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
Time Frame: the number and consistency of the stool will be recorded at 6th week of intervention
the number and consistency of the stool will be recorded at 6th week of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of stools delivered at 6th week of intervention
Time Frame: the number of the stools will be recorded at the 6th week of intervention
the number of the stools will be recorded at the 6th week of intervention
the number of incontinence episodes
Time Frame: the number of the incontinence episodes will be recorded at the 6th week of intervention
the number of the incontinence episodes will be recorded at the 6th week of intervention
the number of painful defecation
Time Frame: the number of painful defecation will be recorded at the 6th week of intervention
the number of painful defecation will be recorded at the 6th week of intervention
the number of episodes of abdominal pain
Time Frame: the number of the episodes of abdominal pain will be recorded at the 6th week of intervention
the number of the episodes of abdominal pain will be recorded at the 6th week of intervention
the number of patients needed laxatives during treatment
Time Frame: the number patiens needed laxatives will be recorded for six weeks of intervention
the number patiens needed laxatives will be recorded for six weeks of intervention
side effects
Time Frame: the number and the character of the side effects will be recorded for six weeks of intervention
the number and character of the sides effects will be recorded by the patient at the diary during the 6 weeks of the intervention
the number and the character of the side effects will be recorded for six weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 9, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

November 3, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2013 (Other Grant/Funding Number: The Medical University of Warsaw)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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