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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

Page last updated: August 23, 2015

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