Status:
COMPLETED
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Colon Cleansing
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2014
Estimated Enrollment :
2154 Patients enrolled
Trial Details
Trial ID
NCT01427296
Start Date
September 16 2011
End Date
December 9 2014
Last Update
January 18 2018
Active Locations (18)
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1
San Carlos, California, United States
2
Bristol, Connecticut, United States
3
Macon, Georgia, United States
4
Suwanee, Georgia, United States