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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: NA
Last verified: September 2005
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: HalfLytely Bowel Prep System for Colonoscopy

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
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

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

Keywords provided by Braintree Laboratories:
colonoscopy preparation
prep

ClinicalTrials.gov processed this record on October 16, 2012