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

September 7, 2005
September 12, 2005
February 7, 2013
January 2003
September 2004   (Final data collection date for primary outcome measure)
Greater than 2 bowel movements per week
Same as current
Complete list of historical versions of study NCT00153114 on Archive Site
  • Analysis of individual ROME I criteria
  • Safety (adverse event and laboratory testing)
Same as current
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PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: polyethyleneglycol3350
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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September 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 16 Years   (Child)
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Contact information is only displayed when the study is recruiting subjects
United States
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Braintree Laboratories
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Principal Investigator: Samuel Nurko, MD Boston Children’s Hospital
Braintree Laboratories
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP