HalfLytely Bowel Prep System for Colonoscopy

This study has been completed.

Sponsor:

Information provided by:

Braintree Laboratories

ClinicalTrials.gov Identifier:

NCT00164164

First received: September 9, 2005

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

February 6, 2013

Start Date ^ICMJE

August 1999

Primary Completion Date

June 2000 (final data collection date for primary outcome measure)

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

Complete list of historical versions of study NCT00164164 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind

Condition ^ICMJE

Colonoscopy

Intervention ^ICMJE

Drug: HalfLytely
Drug: NuLytely

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

Not Provided

Primary Completion Date

June 2000 (final data collection date for primary outcome measure)

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

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00164164

Other Study ID Numbers ^ICMJE

F38-20

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Braintree Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Charles Brady, MD

University of Texas Health Science Center San Antonio

Information Provided By

Braintree Laboratories

Verification Date

February 2013

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

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