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

NCT ID: NCT00251979

Last Updated: 2011-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-12-31

Brief Summary

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This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

Detailed Description

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Conditions

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Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Esomeprazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Nexium Medical Sciences Director

Role: STUDY_DIRECTOR

AstraZeneca

Joseph Sung, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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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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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

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Countries

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Austria Denmark Finland France Germany Greece Hong Kong Netherlands Norway Romania Russia South Africa Spain Sweden Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 28070941 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21181319 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20151726 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19221370 (View on PubMed)

Other Identifiers

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D961DC00001

Identifier Type: -

Identifier Source: org_study_id

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