HalfLytely Bowel Prep System for Colonoscopy
Information source: Braintree Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Intervention: HalfLytely (Drug); NuLytely (Drug)
Phase: Phase 3
Sponsored by: Braintree Laboratories
Official(s) and/or principal investigator(s):
Charles Brady, MD, Principal Investigator, Affiliation: University of Texas Health Science Center San Antonio
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.
Official title: HalfLytely Bowel Prep System for Colonoscopy
Study design: Randomized, Single Blind, Active Control, Parallel Assignment
Primary outcome: Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner
Secondary outcome: Safety - Review of preparation symptoms, adverse events, and laboratory testing
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- Patient is undergoing a colonoscopy for a routinely accepted indication
- possible intestinal obstruction or perforation
- prior alimentary tract surgery
- significant gastroparesis or gastric outlet obstruction
- impaired consciousness that predisposes a patient to pulmonary aspiration
Locations and Contacts
Braintree, Massachusetts 02184, United States
San Antonio, Texas 78284, United States
Starting date: August 1999
Last updated: September 9, 2005