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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00402259
First received: November 17, 2006
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  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

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
  More Information

No publications provided

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
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Omeprazole
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014