PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

NCT ID: NCT00153114

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

polyethyleneglycol3350

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Principal Investigators

Samuel Nurko, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston, Massachusetts, United States

Morristown, New Jersey, United States

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

851-15

Identifier Type: -

Identifier Source: org_study_id