Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
- Conditions
- Upper Gastrointestinal Bleeding
- Interventions
- Registration Number
- NCT00045799
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
- Detailed Description
This trial will be a triple-blind, double-dummy, prospective, multicenter, randomized clinical trial comparing the effectiveness of OSB-IR to the effectiveness of intravenous cimetidine in preventing upper GI bleeding at risk for SRMD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omeprazole sodium bicarbonate immediate release PWD/FS Omeprazole sodium bicarbonate immediate release PWD/FS - Cimetidine IV Cimetidine IV -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
Verdugo Hills Hospital
🇺🇸Burbank, California, United States
Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
Providence St. Joseph's Medical Center
🇺🇸Burbank, California, United States
Protocare Trials
🇺🇸Austell, Georgia, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Akron General Hospital
🇺🇸Akron, Ohio, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
University of Iowa Health Care
🇺🇸Iowa City, Iowa, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
St. Vincent's Catholic Medical Center
🇺🇸New York, New York, United States
Protocare - Alexian Brothers Center for Clinical Research
🇺🇸Elk Grove Village, Illinois, United States
Texas Tech University Health Sciences Center
🇺🇸Odessa, Texas, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
West Suburban Hospital
🇺🇸Oak Park, Illinois, United States
Trinitas Hospital
🇺🇸Elizabeth, New Jersey, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
West Virginia University Hospitals, Inc
🇺🇸Morgantown, West Virginia, United States
Cooper Hospital/UMC
🇺🇸Camden, New Jersey, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
SUNY Health Science Center
🇺🇸Brooklyn, New York, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Arizona Pulmonary Specialists
🇺🇸Phoenix, Arizona, United States
Maricopa Medical Center
🇺🇸Phoenix, Arizona, United States
Pulmonary & Critical Care
🇺🇸Richmond, Virginia, United States
Miami VAMC
🇺🇸Miami, Florida, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Louisiana State University
🇺🇸Shreveport, Louisiana, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
St. Johns Hospital
🇺🇸Springfield, Missouri, United States
Department of Medicine
🇺🇸Kansas City, Kansas, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
University Hospital
🇺🇸Newark, New Jersey, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
North Texas Affiliated Medical Group
🇺🇸Fort Worth, Texas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona Pulmonary Specialists, Ltd
🇺🇸Phoenix, Arizona, United States
Shands Hospital at the University of Florida
🇺🇸Gainesville, Florida, United States
USF Pulmonary Research
🇺🇸Tampa, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Medical Center of LA at New Orleans (LSU Health Sci Ctr)
🇺🇸New Orleans, Louisiana, United States
Truman Medical Center Hospital Hill
🇺🇸Kansas City, Missouri, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States