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Completed Phase 3 Interventional

Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill

ClinicalTrials.gov ID: NCT00045799

Public ClinicalTrials.gov record NCT00045799. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00045799
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
354 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2002 (Type not available)
Primary completion
Not listed
Completion
May 2003 (Actual)
Last update posted
Nov 25, 2019

2002 – 2003

United States locations

U.S. sites
58
U.S. states
27
U.S. cities
52
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
University of South Alabama Mobile Alabama 36617 —
Arizona Pulmonary Specialists Phoenix Arizona 85006 —
Maricopa Medical Center Phoenix Arizona 85008 —
Arizona Pulmonary Specialists, Ltd Phoenix Arizona 85013 —
Scottsdale Healthcare Scottsdale Arizona 85258 —
Alta Bates Summit Medical Center Berkeley California 94705 —
Providence St. Joseph's Medical Center Burbank California 91505 —
Verdugo Hills Hospital Burbank California 91505 —
Loma Linda Medical Center Loma Linda California 92354 —
Stanford University School of Medicine Stanford California 94305 —
Christiana Hospital Newark Delaware 19718 —
PAB Clinical Research Brandon Florida 33511 —
Shands Hospital at the University of Florida Gainesville Florida 32610 —
University of Florida Gainesville Florida 32610 —
Miami VAMC Miami Florida 33125 —
Jackson Memorial Hospital Miami Florida 33136 —
USF Pulmonary Research Tampa Florida 33606 —
Protocare Trials Austell Georgia 30106 —
Wellstar Kennestone Hospital Marietta Georgia 30060 —
Protocare - Alexian Brothers Center for Clinical Research Elk Grove Village Illinois 60007 —
West Suburban Hospital Oak Park Illinois 60302 —
University of Iowa Health Care Iowa City Iowa 52242 —
Department of Medicine Kansas City Kansas 66160 —
Medical Center of LA at New Orleans (LSU Health Sci Ctr) New Orleans Louisiana 70112 —
Louisiana State University Shreveport Louisiana 71130 —
Baystate Medical Center Springfield Massachusetts 01199 —
University of Massachusetts Worcester Massachusetts 01655 —
William Beaumont Hospital Royal Oak Michigan 48073 —
Hennepin County Medical Center Minneapolis Minnesota 55414 —
University of Minnesota Minneapolis Minnesota 55455 —
Regions Hospital Saint Paul Minnesota 55101 —
Truman Medical Center Hospital Hill Kansas City Missouri 64108 —
St. Johns Hospital Springfield Missouri 65804 —
Washington University School of Medicine St Louis Missouri 63109 —
University of Nebraska Omaha Nebraska 68198 —
Cooper Hospital/UMC Camden New Jersey 08103 —
Trinitas Hospital Elizabeth New Jersey 07207 —
Morristown Memorial Hospital Morristown New Jersey 07960 —
University Hospital Newark New Jersey 07103 —
SUNY Health Science Center Brooklyn New York 11203 —
Winthrop University Hospital Mineola New York 11501 —
Long Island Jewish Medical Center New Hyde Park New York 11040 —
St. Vincent's Catholic Medical Center New York New York 10011 —
University of Rochester Medical Center Rochester New York 14642 —
Duke University Medical Center Durham North Carolina 27710 —
Akron General Hospital Akron Ohio 44307 —
The Toledo Hospital Toledo Ohio 43606 —
Oregon Health & Science University Portland Oregon 97201 —
Abington Memorial Hospital Abington Pennsylvania 19001 —
University of Tennessee Memphis Tennessee 38163 —
Vanderbilt University Nashville Tennessee 37212 —
North Texas Affiliated Medical Group Fort Worth Texas 76104 —
Texas Tech University Health Sciences Center Odessa Texas 79763 —
University of Vermont Burlington Vermont 05401 —
Pulmonary & Critical Care Richmond Virginia 23249 —
West Virginia University Hospitals, Inc Morgantown West Virginia 26506 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00045799, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 25, 2019 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00045799 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →