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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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