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A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 9, 2005
Last updated: May 18, 2011
Last verified: May 2011
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

Condition Intervention Phase
Gastrointestinal Hemorrhage Drug: Esomeprazole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo [ Time Frame: Within 72 hours ]

Secondary Outcome Measures:
  • Clinically Significant Rebleeding Within 7 Days [ Time Frame: Within 7 days ]
  • Clinically Significant Rebleeding Within 30 Days [ Time Frame: Within 30 days ]
  • Death Within 72 Hours [ Time Frame: Within 72 hours ]
  • Death Within 30 Days [ Time Frame: Within 30 days ]
  • Death Related to Rebleeding Within 30 Days as Judged by the EpC [ Time Frame: Within 30 days ]
  • Requirement for Surgery Within 72 Hours [ Time Frame: Within 72 hours ]
  • Requirement for Surgery Within 30 Days [ Time Frame: Within 30 days ]
  • Requirement for Endoscopic Re-treatment Within 72 Hours [ Time Frame: Within 72 hours ]
  • Requirement for Endoscopic Re-treatment Within 30 Days [ Time Frame: Within 30 days ]
  • Number of Blood Units Transfused Within 72 Hours [ Time Frame: Within 72 hours ]
  • Number of Blood Units Transfused Within 30 Days [ Time Frame: within 30 days ]
  • Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period [ Time Frame: Within 30 days ]

Enrollment: 1312
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00251979

  Hide Study Locations
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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Wels, Austria
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Wien, Austria
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Aalborg, Denmark
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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
Hong Kong
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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
Russian Federation
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Moscow, Russian Federation
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Saint Petersburg, Russian Federation
South Africa
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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
United Kingdom
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Birmingham, United Kingdom
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Derby, United Kingdom
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Leeds, United Kingdom
Sponsors and Collaborators
Study Director: AstraZeneca Nexium Medical Sciences Director AstraZeneca
Principal Investigator: Joseph Sung, MD Chinese University of Hong Kong
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00251979     History of Changes
Other Study ID Numbers: D961DC00001
Study First Received: November 9, 2005
Results First Received: December 12, 2008
Last Updated: May 18, 2011

Additional relevant MeSH terms:
Peptic Ulcer
Gastrointestinal Hemorrhage
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on September 21, 2017