Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
NCT ID: NCT01427296
Last Updated: 2018-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
2154 participants
INTERVENTIONAL
2011-09-16
2014-12-09
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
NONE
Study Groups
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OsmoPrep Tablets
Oral sodium phosphate solution
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
HalfLytely and Bisacodyl Tablet
Polyethylene glycol
HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
Interventions
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Polyethylene glycol
HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
Oral sodium phosphate solution
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
Eligibility Criteria
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Inclusion Criteria
* Scheduled for colonoscopy within 21 days of the screening visit
* Able to swallow tablets the size of a multivitamin without difficulty
Exclusion Criteria
* Known allergy or hypersensitivity to treatment arms
* History of gastric stapling or bypass procedure or history of gastric retention
* History of any other sodium phosphate preparation within 6 months prior to colonoscopy
18 Years
70 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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San Carlos, California, United States
Bristol, Connecticut, United States
Macon, Georgia, United States
Suwanee, Georgia, United States
Hagerstown, Maryland, United States
Wyoming, Michigan, United States
Mexico, Missouri, United States
Vineland, New Jersey, United States
Great Neck, New York, United States
New York, New York, United States
Fayetteville, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Mentor, Ohio, United States
Plano, Texas, United States
Chesapeake, Virginia, United States
Bellevue, Washington, United States
Countries
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Other Identifiers
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OSBP4011
Identifier Type: -
Identifier Source: org_study_id
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