PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

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