PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

NCT00153114 | Completed Phase 4

• 1 other identifier: 851-15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Greater than 2 bowel movements per week

Secondary Outcomes (2)

• Analysis of individual ROME I criteria

• Safety (adverse event and laboratory testing)

Interventions

polyethyleneglycol3350 DRUG

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (3)

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Morristown, New Jersey, 07962, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Nurko, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2003
• Primary Completion: September 1, 2004
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (3)