A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
Phase 3
Completed
- Conditions
- Gastrointestinal Hemorrhage
- Registration Number
- NCT00251979
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1312
Inclusion Criteria
- Signs of a bleeding in the stomach
- One endoscopically confirmed bleeding ulcer in the stomach or duodenum
Exclusion Criteria
- Malignancy or other advanced disease.
- Major cardiovascular event.
- Severe hepatic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo Within 72 hours
- Secondary Outcome Measures
Name Time Method Clinically Significant Rebleeding Within 7 Days Within 7 days Clinically Significant Rebleeding Within 30 Days Within 30 days Death Within 72 Hours Within 72 hours Death Within 30 Days Within 30 days Death Related to Rebleeding Within 30 Days as Judged by the EpC Within 30 days Requirement for Surgery Within 72 Hours Within 72 hours Requirement for Surgery Within 30 Days Within 30 days Requirement for Endoscopic Re-treatment Within 72 Hours Within 72 hours Requirement for Endoscopic Re-treatment Within 30 Days Within 30 days Number of Blood Units Transfused Within 72 Hours Within 72 hours Number of Blood Units Transfused Within 30 Days within 30 days Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period Within 30 days
Trial Locations
- Locations (1)
Research Site
🇬🇧Leeds, United Kingdom