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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT00621920
Eligibility Criteria:
Inclusion Criteria:
* Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
* Are able to communicate with study personnel and comply with study requirements.
* Are able and willing to follow study-specified testing, diet, and hydration regimen.
* Have been informed of the nature and risks of the study and have given written informed consent.
Exclusion Criteria:
* Have known or suspected liver disease or any history of abnormal liver function tests.
* Have clinically active cardiovascular disease within the past 6 months.
* Have blood pressure greater than 150/90 mm Hg.
* Have known or suspected renal insufficiency.
* Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
* Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
* Have diabetes or a history of diabetes.
* Have clinical evidence of dehydration.
* Are pregnant or breast-feeding.
* Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.
* Use prohibited medications of the study in the defined timeframes.
* Have received any investigational agent within 30 days before dosing.
* Have any known contraindications to the study treatment.
* Have any known or suspected allergies to the components of the study medication.
* Have any other condition which would make the subject unsuitable for inclusion in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00621920
Study Brief:
Protocol Section:
NCT00621920