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

This study has been completed.

First Received: November 17, 2006 Last Updated: March 11, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00402259

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Gastrointestinal Bleeding

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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

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

Locations

China
Research Site
Shanghai, China
Research Site
Beijing, China
Research Site
Tianjin, China
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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Tore Lind, MD

AstraZeneca

More Information

No publications provided

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

Keywords provided by AstraZeneca:

acute non-variceal upper gastrointestinal bleeding

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Gastrointestinal Hemorrhage
Omeprazole
Enzyme Inhibitors
Hemorrhage
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010