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

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ClinicalTrials.gov Identifier: NCT01427296
Recruitment Status : Completed
First Posted : September 1, 2011
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, 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.

Condition or disease Intervention/treatment Phase
Colon Cleansing Drug: Polyethylene glycol Drug: Oral sodium phosphate solution Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 16, 2011
Actual Primary Completion Date : March 11, 2014
Actual Study Completion Date : December 9, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427296


Locations
United States, California
San Carlos, California, United States
United States, Connecticut
Bristol, Connecticut, United States
United States, Georgia
Macon, Georgia, United States
Suwanee, Georgia, United States
United States, Maryland
Hagerstown, Maryland, United States
United States, Michigan
Wyoming, Michigan, United States
United States, Missouri
Mexico, Missouri, United States
United States, New Jersey
Vineland, New Jersey, United States
United States, New York
Great Neck, New York, United States
New York, New York, United States
United States, North Carolina
Fayetteville, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Mentor, Ohio, United States
United States, Texas
Plano, Texas, United States
United States, Virginia
Chesapeake, Virginia, United States
United States, Washington
Bellevue, Washington, United States
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01427296     History of Changes
Other Study ID Numbers: OSBP4011
First Posted: September 1, 2011    Key Record Dates
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Colon Cleansing
Bowel Prep
Colonoscopy

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives