Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
NCT ID: NCT00045799
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2002-05-31
2003-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Omeprazole sodium bicarbonate immediate release PWD/FS
Omeprazole sodium bicarbonate immediate release PWD/FS
Cimetidine IV
Cimetidine IV
Interventions
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Omeprazole sodium bicarbonate immediate release PWD/FS
Cimetidine IV
Eligibility Criteria
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Exclusion Criteria
1. A status of "No Cardiopulmonary Resuscitation (CPR)".
2. If \>48 hours has elapsed since the patient became eligible for the trial.
3. Known history of vagotomy, pyloroplasty, gastroplasty, or any other gastric surgery.
4. Known allergy to cimetidine or omeprazole.
5. Active GI bleeding (including esophageal and gastric variceal bleeding, duodenal and gastric ulcers).
6. Significant risk of swallowing blood (i.e., severe facial trauma, oral lacerations, hemoptysis).
7. Enteral feedings for the first two days of trial drug treatment.
8. Use of an investigational drug within 30 days prior to randomization.
9. Critical/intensive care unit admission following esophageal, gastric, or duodenal surgery or trauma.
10. Known history of upper gastrointestinal lesions that are likely to bleed (e.g., esophageal or gastric varices, gastric polyps, tumors, etc. but excluding patients with gastric or duodenal ulcer disease).
11. Any medical or surgical condition that precludes administration of an oral medication (i.e., OSB-IR).
12. End stage liver disease.
16 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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PAB Clinical Research
Brandon, Florida, United States
USF Pulmonary Research
Tampa, Florida, United States
Protocare Trials
Austell, Georgia, United States
Shands Hospital at the University of Florida
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
Miami VAMC
Miami, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
Maricopa Medical Center
Phoenix, Arizona, United States
Arizona Pulmonary Specialists, Ltd
Phoenix, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Providence St. Joseph's Medical Center
Burbank, California, United States
Verdugo Hills Hospital
Burbank, California, United States
Loma Linda Medical Center
Loma Linda, California, United States
Stanford University School of Medicine
Stanford, California, United States
Christiana Hospital
Newark, Delaware, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Protocare - Alexian Brothers Center for Clinical Research
Elk Grove Village, Illinois, United States
West Suburban Hospital
Oak Park, Illinois, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Department of Medicine
Kansas City, Kansas, United States
Medical Center of LA at New Orleans (LSU Health Sci Ctr)
New Orleans, Louisiana, United States
Louisiana State University
Shreveport, Louisiana, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Truman Medical Center Hospital Hill
Kansas City, Missouri, United States
St. Johns Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Cooper Hospital/UMC
Camden, New Jersey, United States
Trinitas Hospital
Elizabeth, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
University Hospital
Newark, New Jersey, United States
SUNY Health Science Center
Brooklyn, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
St. Vincent's Catholic Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Akron General Hospital
Akron, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
University of Tennessee
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
North Texas Affiliated Medical Group
Fort Worth, Texas, United States
Texas Tech University Health Sciences Center
Odessa, Texas, United States
University of Vermont
Burlington, Vermont, United States
Pulmonary & Critical Care
Richmond, Virginia, United States
West Virginia University Hospitals, Inc
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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OSB-IR C03
Identifier Type: -
Identifier Source: org_study_id
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