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

Phase 4

Completed

• Conditions: Colon Cleansing
• Interventions: Drug: Oral sodium phosphate solution; Drug: Polyethylene glycol

• Registration Number: NCT01427296
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-09-01
• Study Start: 2011-09-16
• Primary Completion: 2014-03-11
• Study Completion: 2014-12-09
• Status Verified: 2017-12
• Results First Submitted: 2017-12-20
• Results First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Results First Posted: 2018-01-18
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OsmoPrep Tablets	Oral sodium phosphate solution	-
HalfLytely and Bisacodyl Tablet	Polyethylene glycol	-

Primary Outcome Measures

Name	Time	Method
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.	6 months