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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
NameTimeMethod
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or PlaceboWithin 72 hours
Secondary Outcome Measures
NameTimeMethod
Clinically Significant Rebleeding Within 7 DaysWithin 7 days
Clinically Significant Rebleeding Within 30 DaysWithin 30 days
Death Within 72 HoursWithin 72 hours
Death Within 30 DaysWithin 30 days
Death Related to Rebleeding Within 30 Days as Judged by the EpCWithin 30 days
Requirement for Surgery Within 72 HoursWithin 72 hours
Requirement for Surgery Within 30 DaysWithin 30 days
Requirement for Endoscopic Re-treatment Within 72 HoursWithin 72 hours
Requirement for Endoscopic Re-treatment Within 30 DaysWithin 30 days
Number of Blood Units Transfused Within 72 HoursWithin 72 hours
Number of Blood Units Transfused Within 30 Dayswithin 30 days
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment PeriodWithin 30 days

Trial Locations

Locations (1)

Research Site

🇬🇧

Leeds, United Kingdom

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