Upper Gastrointestinal BleedingPhase 3NCT00045799
Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
A Phase 3 study testing Omeprazole sodium bicarbonate immediate release PWD/FS and Cimetidine IV in people with Upper Gastrointestinal Bleeding, run by Bausch Health Americas, Inc. at 58 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- Omeprazole sodium bicarbonate immediate release PWD/FS and Cimetidine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 58 sitesUnited States
- Study dates
- May 2002to May 2003
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Akron General Hospital
Akron, Ohio, 44307
Protocare Trials
Austell, Georgia, 30106
Alta Bates Summit Medical Center
Berkeley, California, 94705
University of Alabama at Birmingham
Birmingham, Alabama, 35294
PAB Clinical Research
Brandon, Florida, 33511
SUNY Health Science Center
Brooklyn, New York, 11203
Providence St. Joseph's Medical Center
Burbank, California, 91505
Verdugo Hills Hospital
Burbank, California, 91505
University of Vermont
Burlington, Vermont, 05401
Cooper Hospital/UMC
Camden, New Jersey, 08103
Duke University Medical Center
Durham, North Carolina, 27710
Trinitas Hospital
Elizabeth, New Jersey, 07207
Protocare - Alexian Brothers Center for Clinical Research
Elk Grove Village, Illinois, 60007
North Texas Affiliated Medical Group
Fort Worth, Texas, 76104
Shands Hospital at the University of Florida
Gainesville, Florida, 32610
University of Florida
Gainesville, Florida, 32610
University of Iowa Health Care
Iowa City, Iowa, 52242
Department of Medicine
Kansas City, Kansas, 66160
Truman Medical Center Hospital Hill
Kansas City, Missouri, 64108
Loma Linda Medical Center
Loma Linda, California, 92354
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
University of Tennessee
Memphis, Tennessee, 38163
Miami VAMC
Miami, Florida, 33125
Jackson Memorial Hospital
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Winthrop University Hospital
Mineola, New York, 11501
Hennepin County Medical Center
Minneapolis, Minnesota, 55414
University of Minnesota
Minneapolis, Minnesota, 55455
University of South Alabama
Mobile, Alabama, 36617
West Virginia University Hospitals, Inc
Morgantown, West Virginia, 26506
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Vanderbilt University
Nashville, Tennessee, 37212
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Medical Center of LA at New Orleans (LSU Health Sci Ctr)
New Orleans, Louisiana, 70112
St. Vincent's Catholic Medical Center
New York, New York, 10011
Christiana Hospital
Newark, Delaware, 19718
University Hospital
Newark, New Jersey, 07103
West Suburban Hospital
Oak Park, Illinois, 60302
Texas Tech University Health Sciences Center
Odessa, Texas, 79763
University of Nebraska
Omaha, Nebraska, 68198
Arizona Pulmonary Specialists
Phoenix, Arizona, 85006
Maricopa Medical Center
Phoenix, Arizona, 85008
Arizona Pulmonary Specialists, Ltd
Phoenix, Arizona, 85013
Oregon Health & Science University
Portland, Oregon, 97201
Pulmonary & Critical Care
Richmond, Virginia, 23249
University of Rochester Medical Center
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Regions Hospital
Saint Paul, Minnesota, 55101
Scottsdale Healthcare
Scottsdale, Arizona, 85258
Louisiana State University
Shreveport, Louisiana, 71130
Baystate Medical Center
Springfield, Massachusetts, 01199
St. Johns Hospital
Springfield, Missouri, 65804
Washington University School of Medicine
St Louis, Missouri, 63109
Stanford University School of Medicine
Stanford, California, 94305
USF Pulmonary Research
Tampa, Florida, 33606
The Toledo Hospital
Toledo, Ohio, 43606
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- Omeprazole sodium bicarbonate immediate release PWD/FS, Cimetidine IV
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole sodium bicarbonate immediate release PWD/FSDrug
Cimetidine IVDrug
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole sodium bicarbonate immediate release PWD/FS | Experimental | Not described Receives: Drug: Omeprazole sodium bicarbonate immediate release PWD/FS |
| Cimetidine IV | Active comparator | Not described Receives: Drug: Cimetidine IV |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2002 (estimated)
- Study startMay 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045799
- Sponsor's protocol ID
- OSB-IR C03
- Status last verified
- Nov 2019
- First submitted
- 9 Sep 2002
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No