PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

Phase 4

Completed

• Conditions: Constipation

• Registration Number: NCT00153114
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Greater than 2 bowel movements per week

Secondary Outcome Measures

Name	Time	Method
Analysis of individual ROME I criteria
Safety (adverse event and laboratory testing)