HalfLytely Bowel Prep System for Colonoscopy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

September 9, 2005

Start Date ^ICMJE

August 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

HalfLytely Bowel Prep System for Colonoscopy

Official Title ^ICMJE

HalfLytely Bowel Prep System for Colonoscopy

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Single Blind, Active Control, Parallel Assignment

Condition ^ICMJE

Colonoscopy

Intervention ^ICMJE

Drug: HalfLytely
Drug: NuLytely

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00164164

Responsible Party

Study ID Numbers ^ICMJE

F38-20

Study Sponsor ^ICMJE

Braintree Laboratories

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Charles Brady, MD

University of Texas Health Science Center San Antonio

Information Provided By

Braintree Laboratories

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP