drugset / Trial / NCT00045799

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

NCT00045799

Phase 3 Completed 354 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2002-05
Primary completion
Completion
2003-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cimetidine Small molecule Intravenous
Subject Omeprazole Other / unclassified

Indications

No indication recorded.