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Completed

NCT Number: NCT00402259

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

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

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Key information

Conditions

Gastrointestinal Hemorrhage Digestive System Diseases Gastrointestinal Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research site, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole IV

Drug

Omeprazole IV

Drug

Primary outcomes

  1. Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment

Secondary outcomes

  1. Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment

  2. Time to absence of clinically significant upper GI bleeding

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Nov 22, 2006
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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