Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
1 other identifier
interventional
354
1 country
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2002
Shorter than P25 for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 9, 2002
CompletedFirst Posted
Study publicly available on registry
September 11, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedNovember 25, 2019
November 1, 2019
September 9, 2002
November 21, 2019
Conditions
Study Arms (2)
Omeprazole sodium bicarbonate immediate release PWD/FS
EXPERIMENTALCimetidine IV
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- Patients will be excluded from trial participation if they meet any of the following criteria:
- A status of "No Cardiopulmonary Resuscitation (CPR)".
- If \>48 hours has elapsed since the patient became eligible for the trial.
- Known history of vagotomy, pyloroplasty, gastroplasty, or any other gastric surgery.
- Known allergy to cimetidine or omeprazole.
- Active GI bleeding (including esophageal and gastric variceal bleeding, duodenal and gastric ulcers).
- Significant risk of swallowing blood (i.e., severe facial trauma, oral lacerations, hemoptysis).
- Enteral feedings for the first two days of trial drug treatment.
- Use of an investigational drug within 30 days prior to randomization.
- Critical/intensive care unit admission following esophageal, gastric, or duodenal surgery or trauma.
- 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).
- Any medical or surgical condition that precludes administration of an oral medication (i.e., OSB-IR).
- End stage liver disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of South Alabama
Mobile, Alabama, 36617, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, 85006, United States
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Arizona Pulmonary Specialists, Ltd
Phoenix, Arizona, 85013, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Alta Bates Summit Medical Center
Berkeley, California, 94705, United States
Providence St. Joseph's Medical Center
Burbank, California, 91505, United States
Verdugo Hills Hospital
Burbank, California, 91505, United States
Loma Linda Medical Center
Loma Linda, California, 92354, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Christiana Hospital
Newark, Delaware, 19718, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
University of Florida
Gainesville, Florida, 32610, United States
Miami VAMC
Miami, Florida, 33125, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
USF Pulmonary Research
Tampa, Florida, 33606, United States
Protocare Trials
Austell, Georgia, 30106, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Protocare - Alexian Brothers Center for Clinical Research
Elk Grove Village, Illinois, 60007, United States
West Suburban Hospital
Oak Park, Illinois, 60302, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Department of Medicine
Kansas City, Kansas, 66160, United States
Medical Center of LA at New Orleans (LSU Health Sci Ctr)
New Orleans, Louisiana, 70112, United States
Louisiana State University
Shreveport, Louisiana, 71130, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55414, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Truman Medical Center Hospital Hill
Kansas City, Missouri, 64108, United States
St. Johns Hospital
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63109, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Cooper Hospital/UMC
Camden, New Jersey, 08103, United States
Trinitas Hospital
Elizabeth, New Jersey, 07207, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
University Hospital
Newark, New Jersey, 07103, United States
SUNY Health Science Center
Brooklyn, New York, 11203, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
St. Vincent's Catholic Medical Center
New York, New York, 10011, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Akron General Hospital
Akron, Ohio, 44307, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
North Texas Affiliated Medical Group
Fort Worth, Texas, 76104, United States
Texas Tech University Health Sciences Center
Odessa, Texas, 79763, United States
University of Vermont
Burlington, Vermont, 05401, United States
Pulmonary & Critical Care
Richmond, Virginia, 23249, United States
West Virginia University Hospitals, Inc
Morgantown, West Virginia, 26506, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2002
First Posted
September 11, 2002
Study Start
May 1, 2002
Study Completion
May 1, 2003
Last Updated
November 25, 2019
Record last verified: 2019-11