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.
Sponsor study identifier
interventional
1,312
16 countries
78
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
November 9, 2005
Actual (reported)November 11, 2005
Actual (reported)December 2007
Actual (reported)December 2007
Actual (reported)June 17, 2011
Actual (reported)Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
Within 72 hours
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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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.
AstraZeneca Nexium Medical Sciences Director
AstraZeneca
Joseph Sung, MD
Chinese University of Hong Kong
1,312 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
Contact the study team to confirm eligibility.
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
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.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)Last Updated
June 17, 2011
Results First Posted
June 17, 2011
Record last verified: 2011-05
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Source: ClinicalTrials.gov.
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