HalfLytely Bowel Prep System for Colonoscopy
Information source: Braintree Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Intervention: HalfLytely (Drug); NuLytely (Drug)
Phase: Phase 3
Status: Completed
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
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.
Clinical Details
Official title: HalfLytely Bowel Prep System for Colonoscopy
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Braintree, Massachusetts 02184, United States
San Antonio, Texas 78284, United States
Additional Information
Starting date: August 1999
Last updated: February 6, 2013
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