Status:
COMPLETED
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
Lead Sponsor:
Braintree Laboratories
Conditions:
Constipation
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
Brief Summary
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00153114
Start Date
January 1 2003
Last Update
February 7 2013
Active Locations (3)
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1
Boston, Massachusetts, United States, 02115
2
Morristown, New Jersey, United States, 07962
3
Pittsburgh, Pennsylvania, United States, 15213