A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
May 18, 2011 updated by: AstraZeneca
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.
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1312
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Braunau/Inn, Austria
- Research Site
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Feldbach, Austria
- Research Site
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Graz, Austria
- Research Site
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Krems, Austria
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Wels, Austria
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Wien, Austria
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Aalborg, Denmark
- Research Site
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Amager, Denmark
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Glostrup, Denmark
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Holstebro, Denmark
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Kobenhavn, Denmark
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Odense, Denmark
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Randers, Denmark
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Slagelse, Denmark
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Helsinki, Finland
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Kuopio, Finland
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Amiens, France
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Bordeaux, France
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Clermont-Ferrand CEDEX 1, France
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Lille, France
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Nice Cedex 3, France
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Paris Cedex 12, France
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Paris Cedex 13, France
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Rouen, France
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Berlin, Germany
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Bochum, Germany
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Celle, Germany
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Dresden, Germany
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Karlsruhe, Germany
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Leipzig, Germany
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Ludwigshafen, Germany
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Magdeburg, Germany
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Weimar, Germany
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Athens, Greece
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Thessaloniki, Greece
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Hong Kong, Hong Kong
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Arnhem, Netherlands
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Dordrecht, Netherlands
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Hengelo, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Zwolle, Netherlands
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Alesund, Norway
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Drammen, Norway
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Kristiansand, Norway
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Lorenskog, Norway
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Oslo, Norway
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Tonsberg, Norway
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Bucharest, Romania
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Craiova, Romania
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Iasi, Romania
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Tg. Mures, Romania
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Timisoara, Romania
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Moscow, Russian Federation
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Saint Petersburg, Russian Federation
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Bloemfontein, South Africa
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Cape Town, South Africa
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Pietermaritzburg, South Africa
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Barcelona, Spain
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Madrid, Spain
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Sabadell, Spain
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Santiago, Spain
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Goteborg, Sweden
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Karlstad, Sweden
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Kristianstad, Sweden
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Linköping, Sweden
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Norrkoping, Sweden
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Ostersund, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Trollhättan, Sweden
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Ankara, Turkey
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Bursa, Turkey
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Izmir, Turkey
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Izmit, Turkey
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Birmingham, United Kingdom
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Derby, United Kingdom
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Leeds, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
Time Frame: Within 72 hours
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Within 72 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Clinically Significant Rebleeding Within 7 Days
Time Frame: Within 7 days
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Within 7 days
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Clinically Significant Rebleeding Within 30 Days
Time Frame: Within 30 days
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Within 30 days
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Death Within 72 Hours
Time Frame: Within 72 hours
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Within 72 hours
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Death Within 30 Days
Time Frame: Within 30 days
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Within 30 days
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Death Related to Rebleeding Within 30 Days as Judged by the EpC
Time Frame: Within 30 days
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Within 30 days
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Requirement for Surgery Within 72 Hours
Time Frame: Within 72 hours
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Within 72 hours
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Requirement for Surgery Within 30 Days
Time Frame: Within 30 days
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Within 30 days
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Requirement for Endoscopic Re-treatment Within 72 Hours
Time Frame: Within 72 hours
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Within 72 hours
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Requirement for Endoscopic Re-treatment Within 30 Days
Time Frame: Within 30 days
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Within 30 days
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Number of Blood Units Transfused Within 72 Hours
Time Frame: Within 72 hours
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Within 72 hours
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Number of Blood Units Transfused Within 30 Days
Time Frame: within 30 days
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within 30 days
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Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
Time Frame: Within 30 days
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Within 30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstraZeneca Nexium Medical Sciences Director, AstraZeneca
- Principal Investigator: Joseph Sung, MD, Chinese University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lau J, Lind T, Persson T, Eklund S. Effect of baseline characteristics on response to proton pump inhibitors in patients with peptic ulcer bleeding. J Dig Dis. 2017 Feb;18(2):99-106. doi: 10.1111/1751-2980.12447.
- Kuipers EJ, Sung JJ, Barkun A, Mossner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. doi: 10.1007/s12325-010-0095-5. Epub 2010 Dec 15.
- Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mossner J, Jensen D, Stuart R, Lau JY, Naucler E, Kilhamn J, Granstedt H, Liljas B, Lind T. Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding. Pharmacoeconomics. 2010;28(3):217-30. doi: 10.2165/11531480-000000000-00000.
- Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
November 9, 2005
First Submitted That Met QC Criteria
November 9, 2005
First Posted (Estimate)
November 11, 2005
Study Record Updates
Last Update Posted (Estimate)
June 17, 2011
Last Update Submitted That Met QC Criteria
May 18, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Duodenal Diseases
- Hemorrhage
- Peptic Ulcer
- Gastrointestinal Hemorrhage
- Peptic Ulcer Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Esomeprazole
Other Study ID Numbers
- D961DC00001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.