NCT01427296

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,154 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cleansing

Interventions

Type	Name	Description
DRUG	Polyethylene glycol	HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
DRUG	Oral sodium phosphate solution	OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L

Timeline

• Start date: 2011-09-16
• Primary completion: 2014-03-11
• Completion: 2014-12-09
• First posted: 2011-09-01
• Last updated: 2018-01-18
• Results posted: 2018-01-18

Locations

18 sites across 1 country: United States