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

Primary Purpose

Gastrointestinal Hemorrhage

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo

Secondary Outcome Measures

Clinically Significant Rebleeding Within 7 Days
Clinically Significant Rebleeding Within 30 Days
Death Within 72 Hours
Death Within 30 Days
Death Related to Rebleeding Within 30 Days as Judged by the EpC
Requirement for Surgery Within 72 Hours
Requirement for Surgery Within 30 Days
Requirement for Endoscopic Re-treatment Within 72 Hours
Requirement for Endoscopic Re-treatment Within 30 Days
Number of Blood Units Transfused Within 72 Hours
Number of Blood Units Transfused Within 30 Days
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period

Full Information

First Posted
November 9, 2005
Last Updated
May 18, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00251979
Brief Title
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1312 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
Time Frame
Within 72 hours
Secondary Outcome Measure Information:
Title
Clinically Significant Rebleeding Within 7 Days
Time Frame
Within 7 days
Title
Clinically Significant Rebleeding Within 30 Days
Time Frame
Within 30 days
Title
Death Within 72 Hours
Time Frame
Within 72 hours
Title
Death Within 30 Days
Time Frame
Within 30 days
Title
Death Related to Rebleeding Within 30 Days as Judged by the EpC
Time Frame
Within 30 days
Title
Requirement for Surgery Within 72 Hours
Time Frame
Within 72 hours
Title
Requirement for Surgery Within 30 Days
Time Frame
Within 30 days
Title
Requirement for Endoscopic Re-treatment Within 72 Hours
Time Frame
Within 72 hours
Title
Requirement for Endoscopic Re-treatment Within 30 Days
Time Frame
Within 30 days
Title
Number of Blood Units Transfused Within 72 Hours
Time Frame
Within 72 hours
Title
Number of Blood Units Transfused Within 30 Days
Time Frame
within 30 days
Title
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
Time Frame
Within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Sciences Director
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joseph Sung, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Braunau/Inn
Country
Austria
Facility Name
Research Site
City
Feldbach
Country
Austria
Facility Name
Research Site
City
Graz
Country
Austria
Facility Name
Research Site
City
Krems
Country
Austria
Facility Name
Research Site
City
Wels
Country
Austria
Facility Name
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City
Wien
Country
Austria
Facility Name
Research Site
City
Aalborg
Country
Denmark
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City
Amager
Country
Denmark
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Research Site
City
Glostrup
Country
Denmark
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City
Holstebro
Country
Denmark
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City
Kobenhavn
Country
Denmark
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City
Odense
Country
Denmark
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City
Randers
Country
Denmark
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City
Slagelse
Country
Denmark
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City
Helsinki
Country
Finland
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City
Kuopio
Country
Finland
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City
Amiens
Country
France
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City
Bordeaux
Country
France
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City
Clermont-Ferrand CEDEX 1
Country
France
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City
Lille
Country
France
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Research Site
City
Nice Cedex 3
Country
France
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City
Paris Cedex 12
Country
France
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City
Paris Cedex 13
Country
France
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City
Rouen
Country
France
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Berlin
Country
Germany
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City
Bochum
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Germany
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Celle
Country
Germany
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Dresden
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Germany
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Karlsruhe
Country
Germany
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Leipzig
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Germany
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Ludwigshafen
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Germany
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Magdeburg
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Germany
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Weimar
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Germany
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Athens
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Greece
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Thessaloniki
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Greece
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Hong Kong
Country
Hong Kong
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Arnhem
Country
Netherlands
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Dordrecht
Country
Netherlands
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Hengelo
Country
Netherlands
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City
Nieuwegein
Country
Netherlands
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Rotterdam
Country
Netherlands
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Zwolle
Country
Netherlands
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Alesund
Country
Norway
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Drammen
Country
Norway
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Kristiansand
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Norway
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Lorenskog
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Norway
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Oslo
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Norway
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Tonsberg
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Norway
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Bucharest
Country
Romania
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Craiova
Country
Romania
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Iasi
Country
Romania
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Tg. Mures
Country
Romania
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Timisoara
Country
Romania
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Moscow
Country
Russian Federation
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Saint Petersburg
Country
Russian Federation
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Bloemfontein
Country
South Africa
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Cape Town
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South Africa
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Pietermaritzburg
Country
South Africa
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Barcelona
Country
Spain
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Madrid
Country
Spain
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Sabadell
Country
Spain
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Santiago
Country
Spain
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Goteborg
Country
Sweden
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Karlstad
Country
Sweden
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Kristianstad
Country
Sweden
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Linköping
Country
Sweden
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Norrkoping
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Sweden
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Ostersund
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Sweden
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Skövde
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Sweden
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Stockholm
Country
Sweden
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Sundsvall
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Sweden
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City
Trollhättan
Country
Sweden
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Ankara
Country
Turkey
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Bursa
Country
Turkey
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City
Izmir
Country
Turkey
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Izmit
Country
Turkey
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Birmingham
Country
United Kingdom
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Derby
Country
United Kingdom
Facility Name
Research Site
City
Leeds
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28070941
Citation
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.
Results Reference
derived
PubMed Identifier
21181319
Citation
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.
Results Reference
derived
PubMed Identifier
20151726
Citation
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.
Results Reference
derived
PubMed Identifier
19221370
Citation
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.
Results Reference
derived

Learn more about this trial

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

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