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

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.

Completed

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Key information

Conditions

Colon Cleansing

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Carlos, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene glycol

Drug

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

Oral sodium phosphate solution

Drug

OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L

Primary outcomes

Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Sep 1, 2011
Registry last updated: Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed