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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Esomeprazole IV

Intervention Type DRUG

Omeprazole IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No