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

This study is currently recruiting participants.
Verified July 2012 by Salix Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01427296
First received: August 30, 2011
Last updated: May 28, 2013
Last verified: July 2012
  Purpose

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 Intervention Phase
Colon Cleansing
Drug: Polyethylene glycol
Drug: Oral sodium phosphate solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • The number of Acute Kidney Injury events relative to person-time on study [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: August 2011
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427296

Contacts
Contact: Alyson Lineberry 919-415-3377 alyson.lineberry@salix.com

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

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01427296     History of Changes
Other Study ID Numbers: OSBP4011
Study First Received: August 30, 2011
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Salix Pharmaceuticals:
Colon Cleansing
Bowel Prep
Colonoscopy

Additional relevant MeSH terms:
Bisacodyl
Sodium phosphate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014