Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:1/20/2018
Start Date:September 16, 2011
End Date:December 9, 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus
HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.


Inclusion Criteria:

- Between 18 and 70 years of age, inclusive

- Scheduled for colonoscopy within 21 days of the screening visit

- Able to swallow tablets the size of a multivitamin without difficulty

Exclusion Criteria:

- History of biopsy-proven acute phosphate nephropathy

- 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
We found this trial at
18
sites
Clinical Trial Facility in Fayetteville North Carolina
Fayetteville, North Carolina 28304
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Fayetteville, NC
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Clinical Trial Facility in Bellevue Washington
Bellevue, Washington 98007
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Bellevue, WA
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Clinical Trial Facility in Bristol Connecticut
Bristol, Connecticut
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Bristol, CT
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Clinical Trial Facility in Chesapeake Virginia
Chesapeake, Virginia 23320
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Chesapeake, VA
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Clinical Trial Facility in Cincinnati Ohio
Cincinnati, Ohio
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Cincinnati, OH
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Clinical Trial Facility in Great Neck New York
Great Neck, New York 11021
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Great Neck, NY
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Clinical Trial Facility in Hagerstown Maryland
Hagerstown, Maryland
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Hagerstown, MD
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Clinical Trial Facility in High Point North Carolina
High Point, North Carolina
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High Point, NC
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Clinical Trial Facility in Macon Georgia
Macon, Georgia 31217
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Macon, GA
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Clinical Trial Facility in Mentor Ohio
Mentor, Ohio 44060
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from
Mentor, OH
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Clinical Trial Facility in Mexico Missouri
Mexico, Missouri
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from
Mexico, MO
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in Plano Texas
Plano, Texas 75024
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Plano, TX
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Clinical Trial Facility in Raleigh North Carolina
Raleigh, North Carolina 27607
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Raleigh, NC
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Clinical Trial Facility in San Carlos California
San Carlos, California
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San Carlos, CA
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Clinical Trial Facility in Suwanee Georgia
Suwanee, Georgia 30024
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Suwanee, GA
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Clinical Trial Facility in Vineland New Jersey
Vineland, New Jersey 08360
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Vineland, NJ
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Clinical Trial Facility in Wyoming Michigan
Wyoming, Michigan 45519
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from
Wyoming, MI
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