PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

Braintree Laboratories

Status and phase

Completed

Phase 4

Conditions

Constipation

Treatments

Drug: polyethyleneglycol3350

Study type

Interventional

Funder types

Industry

Identifiers

NCT00153114

851-15

Details and patient eligibility

About

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

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

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