Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Hemorrhage

Treatments: Drug: Omeprazole IV; Drug: Esomeprazole IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402259

D961DL00004

Nexium PUB

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding

Enrollment: 440 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18-65 years.
• GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
• One endoscopically confirmed bleeding peptic ulcer or erosive gastritis

Exclusion criteria

• GI bleeding caused by Esophageal varices
• Mallory Weiss syndrome
• Zollinger-Ellison syndrome
• Suspicion of gastric malignancy at baseline endoscopy
• Post-Billroth-resection
• Unknown source of GI bleeding · 2.Unstable vital signs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind