PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00153114
First received: September 7, 2005
Last updated: February 6, 2013
Last verified: February 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00153114     History of Changes
Other Study ID Numbers: 851-15
Study First Received: September 7, 2005
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014