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PolyethyleneGlycol3350 Laxative Vs Placebo in Constipated Children
This study has been completed.
First Received: September 7, 2005   No Changes Posted
Sponsored by: Braintree Laboratories
Information provided by: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00153114
  Purpose

Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.


Condition Intervention Phase
Constipation
Drug: polyethyleneglycol3350
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: PolyethyleneGlycol3350 Laxative Vs Placebo in Constipated Children

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Greater than 2 bowel movements per week

Secondary Outcome Measures:
  • Analysis of individual ROME I criteria
  • Safety (adverse event and laboratory testing)

Estimated Enrollment: 100
Study Start Date: January 2003
  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153114

Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New Jersey
Morristown, New Jersey, United States, 07962
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Braintree Laboratories
Investigators
Principal Investigator: Samuel Nurko, MD Children's Hospital Boston
  More Information

No publications provided

Study ID Numbers: 851-15
Study First Received: September 7, 2005
Last Updated: September 7, 2005
ClinicalTrials.gov Identifier: NCT00153114     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Laxatives
Signs and Symptoms, Digestive
Constipation
Cathartics

Additional relevant MeSH terms:
Signs and Symptoms
Laxatives
Signs and Symptoms, Digestive
Therapeutic Uses
Gastrointestinal Agents
Constipation
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 30, 2009