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

Phase 3

Completed

• Conditions: Upper Gastrointestinal Bleeding
• Interventions: Drug: Omeprazole sodium bicarbonate immediate release PWD/FS; Drug: Cimetidine IV

• Registration Number: NCT00045799
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-09-09
• Study First Submitted QC: 2002-09-10
• Study First Posted: 2002-09-11
• Study Completion: 2003-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omeprazole sodium bicarbonate immediate release PWD/FS	Omeprazole sodium bicarbonate immediate release PWD/FS	-
Cimetidine IV	Cimetidine IV	-

Trial Locations

Locations (58)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

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

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