ASTERIX: Low Dose ASA and Nexium

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251966
First received: November 9, 2005
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
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 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.

Estimated Enrollment: 960
Study Start Date: May 2004
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251966

  Hide Study Locations
Locations
Australia, New South Wales
Research Site
Bondi Junction, New South Wales, Australia
Australia, Queensland
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Bracken Ridge, Queensland, Australia
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Carina Heights, Queensland, Australia
Australia, South 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
Australia, Victoria
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Ballarat, Victoria, Australia
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Malvern, Victoria, Australia
Bulgaria
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Burgas, Bulgaria
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Pleven, Bulgaria
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Russe, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
Canada, Alberta
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Edmonton, Alberta, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
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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
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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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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Sudbury, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Prince Edward Island
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Parkdale, Prince Edward Island, Canada
Canada, Quebec
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Courcelette, Quebec, Canada
Canada
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Quebec, Canada
Germany
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Stuttgart, Baden-Württemberg, Germany
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München, Bayern, Germany
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Cottbus, Brandenburg, Germany
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Frankfurt, Hessen, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Hannover, Niedersachsen, Germany
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Düsseldorf, Nordrhein-Westfalen, Germany
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Münster, Nordrhein-Westfalen, Germany
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Mainz, Rheinland-Pfalz, Germany
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Halle, Sachsen-Anhalt, Germany
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Hamburg, Germany
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Herne, Germany
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Köln, 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
Greece
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Athens, Greece
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Ioannina, Greece
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Piraeus, Greece
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Thessaloniki, Greece
Hong Kong
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Hong Kong, Hong Kong
Hungary
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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
Italy
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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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Napoli, Italy
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Roma, Italy
South Africa
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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
Spain
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Santiago, A Coruña, Spain
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Santiago de Compostela, A Coruña, Spain
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San Sebastián, Guipuzcoa, Spain
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Granada, Spain
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Madrid, Spain
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Murcia, Spain
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Sevilla, Spain
United Kingdom
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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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
Principal Investigator: Neville Yeomans, MD Perth Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00251966     History of Changes
Other Study ID Numbers: D9617C00011
Study First Received: November 9, 2005
Last Updated: March 11, 2009
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
Prevention of gastroduodenal lesions
erosive oesophagitis
upper GI symptoms

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014