PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153114
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 7, 2013
Information provided by:
Braintree Laboratories

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

Condition or disease Intervention/treatment Phase
Constipation Drug: polyethyleneglycol3350 Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
Study Start Date : January 2003
Actual Primary Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Macrogol
U.S. FDA Resources

Primary Outcome Measures :
  1. Greater than 2 bowel movements per week

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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153114

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
Principal Investigator: Samuel Nurko, MD Boston Children’s Hospital Identifier: NCT00153114     History of Changes
Other Study ID Numbers: 851-15
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Gastrointestinal Agents