Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Information source: Salix Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colon Cleansing
Intervention: Polyethylene glycol (Drug); Oral sodium phosphate solution (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Salix Pharmaceuticals
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The number of Acute Kidney Injury events relative to person-time on study
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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
Additional Information
Starting date: August 2011
Last updated: May 30, 2014
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