BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
NCT ID: NCT00856843
Last Updated: 2010-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polyethylene glycol 3350 based bowel preparation
Polyethylene glycol 3350 based bowel preparation
Polyethylene glycol 3350 based bowel preparation
Solution for oral administration prior to colonoscopy
BLI800
BLI800
BLI800
Solution for oral administration prior to colonoscopy
Interventions
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BLI800
Solution for oral administration prior to colonoscopy
Polyethylene glycol 3350 based bowel preparation
Solution for oral administration prior to colonoscopy
Eligibility Criteria
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Inclusion Criteria
2. At least 18 years of age
3. Otherwise in good health, as determined by physical exam and medical history
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative urine pregnancy test at screening, if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria
2. Subjects who had previous gastrointestinal surgeries.
3. Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. 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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Braintree Laboratories, Inc.
Principal Investigators
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John McGowan, MPH
Role: STUDY_DIRECTOR
Braintree Laboratories, Inc.
Locations
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University of South Alabama
Mobile, Alabama, United States
Jupiter Research
Jupiter, Florida, United States
Miami Research Associates
Miami, Florida, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Long Island GI Research Group
Great Neck, New York, United States
Countries
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References
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Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19.
Other Identifiers
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BLI800-303
Identifier Type: -
Identifier Source: org_study_id