Back to resultsEfficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
Primary Purpose
Gastrointestinal Hemorrhage
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Esomeprazole IV
Omeprazole IV
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Hemorrhage focused on measuring acute non-variceal upper gastrointestinal bleeding
Eligibility 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
Sites / Locations
- Research site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00402259
Brief Title
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage
Keywords
acute non-variceal upper gastrointestinal bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole IV
Intervention Type
Drug
Intervention Name(s)
Omeprazole IV
Primary Outcome Measure Information:
Title
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
Title
Time to absence of clinically significant upper GI bleeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Lind, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
Facility Name
Research Site
City
Tianjin
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
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