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

Completed · Phase 3

Conditions studied: Upper Gastrointestinal Bleeding

In brief

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.

Key facts

Study ID

NCT00045799

Run by

Bausch Health Americas, Inc.

People needed

354

Starts

2002-05-01

Expected to finish

2003-05-01

Last updated by the study team

2019-11-25

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• PAB Clinical Research — Brandon, Florida, 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
• USF Pulmonary Research — Tampa, Florida, United States
• Protocare Trials — Austell, Georgia, 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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