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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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
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Plano, TX
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Bellevue, WA
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Bristol, CT
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Chesapeake, VA
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Cincinnati, OH
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Fayetteville, North Carolina 28304
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Fayetteville, NC
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Great Neck, NY
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Hagerstown, MD
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High Point, NC
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Macon, GA
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Mentor, OH
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Mexico, MO
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New York, NY
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Raleigh, NC
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San Carlos, CA
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Suwanee, GA
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Vineland, NJ
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Wyoming, MI
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