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

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:

MedlinePlus related topics: Endoscopy Gastrointestinal Bleeding Peptic Ulcer

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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

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
Research Site
Graz, Austria
Research Site
Krems, Austria
Research Site
Wels, Austria
Research Site
Wien, Austria
Denmark
Research Site
Aalborg, Denmark
Research Site
Amager, Denmark
Research Site
Glostrup, Denmark
Research Site
Holstebro, Denmark
Research Site
Kobenhavn, Denmark
Research Site
Odense, Denmark
Research Site
Randers, Denmark
Research Site
Slagelse, Denmark
Finland
Research Site
Helsinki, Finland
Research Site
Kuopio, Finland
France
Research Site
Amiens, France
Research Site
Bordeaux, France
Research Site
Clermont-Ferrand CEDEX 1, France
Research Site
Lille, France
Research Site
Nice Cedex 3, France
Research Site
Paris Cedex 12, France
Research Site
Paris Cedex 13, France
Research Site
Rouen, France
Germany
Research Site
Berlin, Germany
Research Site
Bochum, Germany
Research Site
Celle, Germany
Research Site
Dresden, Germany
Research Site
Karlsruhe, Germany
Research Site
Leipzig, Germany
Research Site
Ludwigshafen, Germany
Research Site
Magdeburg, Germany
Research Site
Weimar, Germany
Greece
Research Site
Athens, Greece
Research Site
Thessaloniki, Greece
Hong Kong
Research Site
Hong Kong, Hong Kong
Netherlands
Research Site
Arnhem, Netherlands
Research Site
Dordrecht, Netherlands
Research Site
Hengelo, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Zwolle, Netherlands
Norway
Research Site
Alesund, Norway
Research Site
Drammen, Norway
Research Site
Kristiansand, Norway
Research Site
Lorenskog, Norway
Research Site
Oslo, Norway
Research Site
Tonsberg, Norway
Romania
Research Site
Bucharest, Romania
Research Site
Craiova, Romania
Research Site
Iasi, Romania
Research Site
Tg. Mures, Romania
Research Site
Timisoara, Romania
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Saint Petersburg, Russian Federation
South Africa
Research Site
Bloemfontein, South Africa
Research Site
Cape Town, South Africa
Research Site
Pietermaritzburg, South Africa
Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Sabadell, Spain
Research Site
Santiago, Spain
Sweden
Research Site
Goteborg, Sweden
Research Site
Karlstad, Sweden
Research Site
Kristianstad, Sweden
Research Site
Linköping, Sweden
Research Site
Norrkoping, Sweden
Research Site
Ostersund, Sweden
Research Site
Skövde, Sweden
Research Site
Stockholm, Sweden
Research Site
Sundsvall, Sweden
Research Site
Trollhättan, Sweden
Turkey
Research Site
Ankara, Turkey
Research Site
Bursa, Turkey
Research Site
Izmir, Turkey
Research Site
Izmit, Turkey
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Derby, United Kingdom
Research Site
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):

Kuipers EJ, Sung JJ, Barkun A, Mössner 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. Epub 2010 Dec 15.

Sung JJ, Barkun A, Kuipers EJ, Mössner 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. Epub 2009 Feb 16.

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
Omeprazole
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013