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

• Status: Completed
• Trial end date: 2014-12-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Bisacodyl

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