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

Last updated: March 11, 2009
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Hemorrhage

Ulcers

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT00402259
D961DL00004
Nexium PUB
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female aged 18-65 years.

  • GI bleeding or with such signs within 48 hours as judged by the investigator as tohave non-variceal upper GI bleeding.

  • One endoscopically confirmed bleeding peptic ulcer or erosive gastritis

Exclusion

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 Design

Total Participants: 440
Study Start date:
August 01, 2006
Estimated Completion Date:
October 31, 2007

Connect with a study center

  • Research site

    Fuzhou, Fujian
    China

    Site Not Available

  • Research Site

    Guangzhou, Guangdong
    China

    Site Not Available

  • Research Site

    Wuhan, Hubei
    China

    Site Not Available

  • Research Site

    Xi'an, Shanxi
    China

    Site Not Available

  • Research Site

    Beijing,
    China

    Site Not Available

  • Research Site

    Shanghai,
    China

    Site Not Available

  • Research Site

    Tianjin,
    China

    Site Not Available

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