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

March 11, 2009 updated by: AstraZeneca

A Randomised, Double-Blind, Double-Dummy, Active-Controlled, Multicenter Study to Assess the Efficacy and Safety of Esomeprazole or Omeprazole for 5 Days in Subjects With Acute Non-Variceal Upper Gastrointestinal Bleeding

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Tianjin, China
        • Research Site
    • Fujian
      • Fuzhou, Fujian, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Hubei
      • Wuhan, Hubei, China
        • Research Site
    • Shanxi
      • Xi'an, Shanxi, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment

Secondary Outcome Measures

Outcome Measure
Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
Time to absence of clinically significant upper GI bleeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961DL00004
  • Nexium PUB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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