ASTERIX: Low Dose ASA and Nexium
A Randomized Double-Blind Placebo-Controlled Study to Assess the Prevention of Low-Dose Acetylsalicylic Acid (ASA) Associated Gastroduodenal Lesions and Upper Gastrointestinal Symptoms in Patients Taking Esomeprazole 20 mg Once Daily for 26 Weeks.
1 other identifier
interventional
960
11 countries
94
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Shorter than P25 for phase_3
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedMarch 12, 2009
March 1, 2009
November 9, 2005
March 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA.
Secondary Outcomes (1)
LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Upper GI symptoms
- Erosive oesophagitis
- Malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (94)
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, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Science Director, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Neville Yeomans, MD
Perth Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
May 1, 2004
Study Completion
September 1, 2005
Last Updated
March 12, 2009
Record last verified: 2009-03