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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01427296
First received: August 30, 2011
Last updated: May 30, 2014
Last verified: May 2014
  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
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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 30, 2014
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
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014