NCT00045799

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Omeprazole sodium bicarbonate immediate release PWD/FS
DRUG	Cimetidine IV

Timeline

• Start date: 2002-05-01
• Completion: 2003-05-01
• First posted: 2002-09-11
• Last updated: 2019-11-25

Locations

58 sites across 1 country: United States