PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

February 6, 2013 updated by: Braintree Laboratories
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • New Jersey
      • Morristown, New Jersey, United States, 07962
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213

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

4 years to 16 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female outpatients between the ages of 4 to 16 years.
  • Adolescent female patients must not be pregnant or lactating.
  • constipated according to ROME I definition
  • Two or fewer bowel movements during the initial observation week.
  • Absence of a stool impaction
  • Bowel movement after receiving enema
  • Are otherwise in good health, as judged by a physical examination.
  • Parent or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

  • Patients with heme positive stool at baseline exam.
  • Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam
  • Patients with known or suspected perforation or obstruction other than fecal impaction.
  • Patients who are breastfeeding, pregnant or intend to become pregnant during the study.
  • Female patients of childbearing potential who refuse a pregnancy test.
  • Patients with a known history of organic cause for their constipation.
  • Patients with congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases).
  • History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
  • Use of concomitant medications that cause constipation
  • Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
  • Patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications.
  • Patients with clinically significant elevations of TSH or abnormal plasma electrolytes.
  • Patients who, within the past 30 days have participated in an investigational clinical study

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Greater than 2 bowel movements per week

Secondary Outcome Measures

Outcome Measure
Analysis of individual ROME I criteria
Safety (adverse event and laboratory testing)

Collaborators and Investigators

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

Sponsor

Braintree Laboratories

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

January 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 851-15

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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