HalfLytely Bowel Prep System for Colonoscopy

Last updated: February 6, 2013
Sponsor: Braintree Laboratories
Overall Status: Completed

Phase

3

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT00164164
F38-20
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Male or female outpatients at least 18 years of age

  • All women of childbearing potential (this includes women who are single and womenwhose sexual partners have been vasectomized) are required to use medically acceptablecontraception during their participation in the study.

  • In the investigator's judgment, patient is mentally competent to sign an instrument ofinformed consent

  • Patient is undergoing a colonoscopy for a routinely accepted indication

Exclusion

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

Study Design

Total Participants: 200
Study Start date:
August 01, 1999
Estimated Completion Date:

Connect with a study center

  • Braintree, Massachusetts 02184
    United States

    Site Not Available

  • San Antonio, Texas 78284
    United States

    Site Not Available

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