ASTERIX: Low Dose ASA and Nexium

NCT ID: NCT00251966

Last Updated: 2009-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-09-30

Brief Summary

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The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.

Detailed Description

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Conditions

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Gastroesophageal Reflux

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

* A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week).
* Age \>= 60 years.
* No gastric and/or duodenal ulcer at the baseline endoscopy.
* H. pylori negative by serology test at screening.

Exclusion Criteria

* Upper GI symptoms
* Erosive oesophagitis
* Malignancy
Minimum Eligible Age

60 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 Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Neville Yeomans, MD

Role: PRINCIPAL_INVESTIGATOR

Perth Medical School

Locations

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Research Site

Bondi Junction, New South Wales, Australia

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Bracken Ridge, Queensland, Australia

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Carina Heights, Queensland, Australia

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Adelaide, South Australia, Australia

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Ashford, South Australia, Australia

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Wayville, South Australia, Australia

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Woodville, South Australia, Australia

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Ballarat, Victoria, Australia

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Malvern, Victoria, Australia

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Burgas, , Bulgaria

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Pleven, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Carbonear, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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North York, Ontario, Canada

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Oakville, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Parkdale, Prince Edward Island, Canada

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Courcelette, Quebec, Canada

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Québec, Quebec, Canada

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Stuttgart, Baden-Wurttemberg, Germany

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München, Bavaria, Germany

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Cottbus, Brandenburg, Germany

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Hamburg, City state of Hamburg, Germany

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Frankfurt am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Rostock, Mecklenburg-Vorpommern, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Halle, Saxony-Anhalt, Germany

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Cologne, , Germany

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Hamburg, , Germany

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Herne, , Germany

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Künzing, , Germany

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Lienen, , Germany

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Ludwigshafen, , Germany

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Lüdenscheid, , Germany

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Münster, , Germany

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Oelde, , Germany

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Paderborn, , Germany

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Potsdam, , Germany

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Ribnitz-Damgarten, , Germany

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Rostock, , Germany

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Siegen, , Germany

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Wangen, , Germany

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Wiesbaden, , Germany

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Wolfenbüttel, , Germany

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Wolmirstedt, , Germany

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Zeven, , Germany

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Athens, , Greece

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Ioannina, , Greece

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Piraeus, , Greece

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Thessaloniki, , Greece

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Hong Kong, , Hong Kong

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Budapest, , Hungary

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Debrecen, , Hungary

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Eger, , Hungary

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Gyula, , Hungary

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Gy¿r, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Vác, , Hungary

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Bologna, BO, Italy

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Genova, GE, Italy

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Parma, PR, Italy

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Roma, Roma, Italy

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Napoli, , Italy

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Cape Town, , South Africa

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Johannesurg, , South Africa

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Lyttelton Manor, , South Africa

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Parktown, , South Africa

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Tygerberg, , South Africa

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Santiago, A Coruña, Spain

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Santiago de Compostela, A Coruña, Spain

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Granada, Granada, Spain

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San Sebastián, Guipuzcoa, Spain

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Madrid, Madrid, Spain

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Murcia, Murcia, Spain

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Seville, Sevilla, Spain

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Irvine, Ayrshire, United Kingdom

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Glasgow, Scotland, United Kingdom

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Cardiff, South Wales, United Kingdom

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Edinburgh, , United Kingdom

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Countries

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Australia Bulgaria Canada Germany Greece Hong Kong Hungary Italy South Africa Spain United Kingdom

Other Identifiers

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D9617C00011

Identifier Type: -

Identifier Source: org_study_id

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