HalfLytely Bowel Prep System for Colonoscopy

Braintree Laboratories

Status and phase: Completed; Phase 3

Conditions: Colonoscopy

Treatments: Drug: NuLytely; Drug: HalfLytely

Study type: Interventional

Funder types: Industry

Identifiers

NCT00164164

F38-20

Details and patient eligibility

About

The 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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