Constipation
Conditions
Brief summary
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
Interventions
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
* Adult male or female ambulatory outpatient age 19 or older. * Patients meet ROME II Criteria * Patients not meeting ROME IBS criteria * Use of a constipating medication (\>= 3% in PDR) * If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study * Written informed consent.
Exclusion criteria
* Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease. * Prior small bowel or colonic resection or colostomy. * Weight \< 80 lbs. * Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications. * Positive stool hemoccult. * Significant cardiac, renal or hepatic insufficiency. * Pregnant or expecting to become pregnant within 120 days of study enrollment. * Lactating or breast feeding. * Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan. * Use of investigational drugs in the last 30 days. * Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of individual ROME I criteria | — |
| Safety (adverse event and laboratory testing) | — |
Countries
United States
Outcome results
None listed