A Safety Study of 3 Different Bowel Cleansing Preparations
NCT ID: NCT01501513
Last Updated: 2024-01-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
541 participants
INTERVENTIONAL
2011-12-31
2013-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BLI800 approved preparation regimen
BLI800 approved preparation regimen
BLI800 approved preparation regimen
solution for oral administration prior to colonoscopy
BLI800 investigational preparation regimen
BLI800 investigational preparation regimen
BLI800 investigational preparation regimen
solution for oral administration prior to colonoscopy
PEG-3350 based bowel preparation
PEG-3350 based bowel preparation
PEG-3350 based bowel preparation
solution for oral administration prior to colonoscopy
Interventions
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PEG-3350 based bowel preparation
solution for oral administration prior to colonoscopy
BLI800 approved preparation regimen
solution for oral administration prior to colonoscopy
BLI800 investigational preparation regimen
solution for oral administration prior to colonoscopy
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances.
* Subjects with severe liver or renal insufficiency.
* Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects undergoing colonoscopy for foreign body removal and decompression.
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects allergic to any preparation components
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
18 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Locations
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University of South Alabama
Mobile, Alabama, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Delta Research Partners
Monroe, Louisiana, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Gastrointestinal Associates
Jackson, Mississippi, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Northwest Gastroenterology
Portland, Oregon, United States
ClinSearch
Chattanooga, Tennessee, United States
Franklin Gastroenterology
Franklin, Tennessee, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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BLI800-440
Identifier Type: -
Identifier Source: org_study_id
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