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

Gastrointestinal Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402259
• Other study ID #: D961DL00004
• Secondary ID: Nexium PUB
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2006
• Last updated: March 11, 2009
• Start date: August 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

Drug:
• Esomeprazole IV

• Omeprazole IV

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research site	Fuzhou	Fujian
China	Research Site	Guangzhou	Guangdong
China	Research Site	Shanghai
China	Research Site	Tianjin
China	Research Site	Wuhan	Hubei
China	Research Site	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
Secondary	Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
Secondary	Time to absence of clinically significant upper GI bleeding