Status:
COMPLETED
HalfLytely Bowel Prep System for Colonoscopy
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00164164
Start Date
August 1 1999
Last Update
February 7 2013
Active Locations (2)
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1
Braintree, Massachusetts, United States, 02184
2
San Antonio, Texas, United States, 78284