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

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ClinicalTrials.gov Identifier: NCT00402259
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief 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

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Drug: Esomeprazole IV Drug: Omeprazole IV Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment

Secondary Outcome Measures :
  1. Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
  2. Time to absence of clinically significant upper GI bleeding


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402259


Locations
China, Fujian
Research site
Fuzhou, Fujian, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China
Research Site
Beijing, China
Research Site
Shanghai, China
Research Site
Tianjin, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tore Lind, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00402259     History of Changes
Other Study ID Numbers: D961DL00004
Nexium PUB
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
acute non-variceal upper gastrointestinal bleeding

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action