Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT00153127
Eligibility Criteria:
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
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00153127
Study Brief:
Protocol Section:
NCT00153127