A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
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.
1 other identifier
interventional
1,312
16 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
June 17, 2011
CompletedJune 17, 2011
May 1, 2011
2.2 years
November 9, 2005
December 12, 2008
May 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
Within 72 hours
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Signs of a bleeding in the stomach
- One endoscopically confirmed bleeding ulcer in the stomach or duodenum
You may not qualify if:
- Malignancy or other advanced disease.
- Major cardiovascular event.
- Severe hepatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (78)
Research Site
Braunau/Inn, Austria
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Feldbach, Austria
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Graz, Austria
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Krems, Austria
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Vienna, Austria
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Wels, Austria
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Aalborg, Denmark
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Amager, Denmark
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Copenhagen, Denmark
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Glostrup Municipality, Denmark
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Holstebro, 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, France
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Lille, France
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Nice, France
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Paris, 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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Ålesund, 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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Tønsberg, Norway
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Bucharest, Romania
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Craiova, Romania
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Iași, Romania
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Tg. Mures, Romania
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Timișoara, Romania
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Moscow, Russia
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Saint Petersburg, Russia
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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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Gothenburg, Sweden
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Karlstad, Sweden
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Kristianstad, Sweden
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Linköping, Sweden
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Norrköping, Sweden
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Östersund, 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 (Türkiye)
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Bursa, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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İzmit, Turkey (Türkiye)
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Birmingham, United Kingdom
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Derby, United Kingdom
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Leeds, United Kingdom
Related Publications (4)
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.
PMID: 28070941DERIVEDKuipers 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.
PMID: 21181319DERIVEDBarkun 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.
PMID: 20151726DERIVEDSung 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.
PMID: 19221370DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Sciences Director
AstraZeneca
- PRINCIPAL INVESTIGATOR
Joseph Sung, MD
Chinese University of Hong Kong
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
October 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
June 17, 2011
Results First Posted
June 17, 2011
Record last verified: 2011-05