Official Title
HalfLytely Bowel Prep System for Colonoscopy
Phase
Phase 3Lead Sponsor
Braintree LaboratoriesStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
ColonoscopyIntervention/Treatment
polyethylene glycol ...Study Participants
200The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.
Inclusion Criteria: Male or female outpatients at least 18 years of age All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study. In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent Patient is undergoing a colonoscopy for a routinely accepted indication Exclusion Criteria: ileus possible intestinal obstruction or perforation prior alimentary tract surgery significant gastroparesis or gastric outlet obstruction impaired consciousness that predisposes a patient to pulmonary aspiration