PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4

Details

• Lead Sponsor: Braintree Laboratories
• Treatments: Laxatives; Polyethylene glycol 3350

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