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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251979
First received: November 9, 2005
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinically Significant Rebleeding Within 7 Days [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • Clinically Significant Rebleeding Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Death Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
  • Death Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Death Related to Rebleeding Within 30 Days as Judged by the EpC [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Requirement for Surgery Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
  • Requirement for Surgery Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Requirement for Endoscopic Re-treatment Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
  • Requirement for Endoscopic Re-treatment Within 30 Days [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Number of Blood Units Transfused Within 72 Hours [ Time Frame: Within 72 hours ] [ Designated as safety issue: No ]
  • Number of Blood Units Transfused Within 30 Days [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
  • Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00251979

  Hide Study Locations
Locations
Austria
Research Site
Braunau/Inn, Austria
Research Site
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
Denmark
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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
Finland
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Helsinki, Finland
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Kuopio, Finland
France
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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
Germany
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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
Greece
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Athens, Greece
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Thessaloniki, Greece
Hong Kong
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Hong Kong, Hong Kong
Netherlands
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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
Norway
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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
Romania
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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
Spain
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Barcelona, Spain
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Madrid, Spain
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Sabadell, Spain
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Santiago, Spain
Sweden
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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
Turkey
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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
Research Site
Birmingham, United Kingdom
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Derby, United Kingdom
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Leeds, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director AstraZeneca
Principal Investigator: Joseph Sung, MD Chinese University of Hong Kong
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Hemostatics
Esomeprazole
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014