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

December 20, 2017 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Carlos, California, United States
    • Connecticut
      • Bristol, Connecticut, United States
    • Georgia
      • Macon, Georgia, United States
      • Suwanee, Georgia, United States
    • Maryland
      • Hagerstown, Maryland, United States
    • Michigan
      • Wyoming, Michigan, United States
    • Missouri
      • Mexico, Missouri, United States
    • New Jersey
      • Vineland, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
    • North Carolina
      • Fayetteville, North Carolina, United States
      • High Point, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Mentor, Ohio, United States
    • Texas
      • Plano, Texas, United States
    • Virginia
      • Chesapeake, Virginia, United States
    • Washington
      • Bellevue, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OsmoPrep Tablets
Drug: Oral sodium phosphate solution
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
Active Comparator: HalfLytely and Bisacodyl Tablet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2011

Primary Completion (Actual)

March 11, 2014

Study Completion (Actual)

December 9, 2014

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OSBP4011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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