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HalfLytely Bowel Prep System for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164164
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 7, 2013
Sponsor:
Information provided by:
Braintree Laboratories

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: HalfLytely Drug: NuLytely Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: HalfLytely Bowel Prep System for Colonoscopy
Study Start Date : August 1999
Actual Primary Completion Date : June 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Nulytely




Primary Outcome Measures :
  1. Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner

Secondary Outcome Measures :
  1. Safety - Review of preparation symptoms, adverse events, and laboratory testing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164164


Locations
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United States, Massachusetts
Braintree, Massachusetts, United States, 02184
United States, Texas
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Braintree Laboratories
Investigators
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Principal Investigator: Charles Brady, MD University of Texas Health Science Center San Antonio
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ClinicalTrials.gov Identifier: NCT00164164    
Other Study ID Numbers: F38-20
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Braintree Laboratories:
colonoscopy preparation
prep
Additional relevant MeSH terms:
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Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents