Clinical trial: PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children (NCT00153114)

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
No condition on gender to be admitted to the trial.

Subject must be at least 4 Years old.
Subject must be at most 16 Years

Patient description (medical language): A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days.  The patient has had constipation and discomfort with bowel movements since birth.  His symptoms worsened after eating semi-solid foods.  Vital signs are normal.  Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds.  Xray with barium shows a narrow rectum and rectosigmoid area.  The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine.

Patient description (patient's own words): My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine.

Does the patient match the trial criteria? Contradiction