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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402259

Enrollment

440

Registered

2006-11-22

Start date

2006-08-31

Completion date

2007-10-31

Last updated

2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage

Keywords

acute non-variceal upper gastrointestinal bleeding

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

Interventions

DRUGEsomeprazole IV

DRUGOmeprazole IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment	—

Secondary

Measure	Time frame
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	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026