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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: November 17, 2006
Last updated: March 11, 2009
Last verified: March 2009
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 Intervention Phase
Gastrointestinal Hemorrhage
Drug: Esomeprazole IV
Drug: Omeprazole IV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 440
Study Start Date: August 2006
Study Completion Date: October 2007

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402259

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
Research Site
Beijing, China
Research Site
Shanghai, China
Research Site
Tianjin, China
Sponsors and Collaborators
Study Director: Tore Lind, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00402259     History of Changes
Other Study ID Numbers: D961DL00004  Nexium PUB 
Study First Received: November 17, 2006
Last Updated: March 11, 2009
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 30, 2016