HalfLytely Bowel Prep System for Colonoscopy

This study has been completed.

First Received: September 9, 2005 No Changes Posted

Sponsor:	Braintree Laboratories
Information provided by:	Braintree Laboratories
ClinicalTrials.gov Identifier:	NCT00164164

Purpose

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.

Condition	Intervention	Phase
Colonoscopy	Drug: HalfLytely Drug: NuLytely	Phase III

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	HalfLytely Bowel Prep System for Colonoscopy

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy

Drug Information available for: Nulytely

U.S. FDA Resources

Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:

Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner

Secondary Outcome Measures:

Safety - Review of preparation symptoms, adverse events, and laboratory testing

Estimated Enrollment:	200
Study Start Date:	August 1999

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164164

Locations

United States, Massachusetts

Braintree, Massachusetts, United States, 02184
United States, Texas

San Antonio, Texas, United States, 78284

Sponsors and Collaborators

Braintree Laboratories

Investigators

Principal Investigator:

Charles Brady, MD

University of Texas Health Science Center San Antonio

More Information

No publications provided

Study ID Numbers:	F38-20
Study First Received:	September 9, 2005
Last Updated:	September 9, 2005
ClinicalTrials.gov Identifier:	NCT00164164 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:

colonoscopy preparation
prep

ClinicalTrials.gov processed this record on November 05, 2009