Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
Status:
Completed
Trial end date:
2003-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.