Constipation
Conditions
Brief summary
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.
Interventions
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Greater than 2 bowel movements per week | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of individual ROME I criteria | — |
| Safety (adverse event and laboratory testing) | — |
Countries
United States
Outcome results
None listed