Completed

A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

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What is being tested

Data Collection

Who is being recruted

Digestive System Diseases+3

+ Gastrointestinal Diseases

+ Hemorrhage

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: October 2005
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2005

Actual date on which the first participant was enrolled.

This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

Official TitleA Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.
NCT00251979
Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1312 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesHemorrhageGastrointestinal HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
Signs of a bleeding in the stomach

One endoscopically confirmed bleeding ulcer in the stomach or duodenum

3 exclusion criteria prevent from participating
Malignancy or other advanced disease.

Major cardiovascular event.

Severe hepatic disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 78 locations

Suspended

Research Site

Braunau/Inn, AustriaOpen Research Site in Google Maps
Suspended

Research Site

Feldbach, Austria
Suspended

Research Site

Graz, Austria
Suspended

Research Site

Krems, Austria
Completed78 Study Centers