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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
History of Changes

September 7, 2005
February 6, 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 ClinicalTrials.gov 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Constipation
Drug: polyethyleneglycol3350
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Not Provided
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
Both
4 Years to 16 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00153114
851-15
Not Provided
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Braintree Laboratories
Not Provided
Principal Investigator: Samuel Nurko, MD Children's Hospital Boston
Braintree Laboratories
February 2013

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