ASTERIX: Low Dose ASA and Nexium

Condition(s) targeted: Gastroesophageal Reflux

Intervention: Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Neville Yeomans, MD, Principal Investigator, Affiliation: Perth Medical School

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.

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.

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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

Research Site, Burgas, Bulgaria

Research Site, Pleven, Bulgaria

Research Site, Russe, Bulgaria

Research Site, Sofia, Bulgaria

Research Site, Varna, Bulgaria

Research Site, Quebec, Canada

Research Site, Hamburg, Germany

Research Site, Herne, Germany

Research Site, Köln, Germany

Research Site, Künzing, Germany

Research Site, Lienen, Germany

Research Site, Lüdenscheid, Germany

Research Site, Ludwigshafen, Germany

Research Site, MÜNSTER, Germany

Research Site, Oelde, Germany

Research Site, Paderborn, Germany

Research Site, Potsdam, Germany

Research Site, Ribnitz-Damgarten, Germany

Research Site, Rostock, Germany

Research Site, Siegen, Germany

Research Site, Wangen, Germany

Research Site, Wiesbaden, Germany

Research Site, Wolfenbüttel, Germany

Research Site, Wolmirstedt, Germany

Research Site, Zeven, Germany

Research Site, Athens, Greece

Research Site, Ioannina, Greece

Research Site, Piraeus, Greece

Research Site, Thessaloniki, Greece

Research Site, Hong Kong, Hong Kong

Research Site, Budapest, Hungary

Research Site, Debrecen, Hungary

Research Site, Eger, Hungary

Research Site, Gy¿r, Hungary

Research Site, Gyula, Hungary

Research Site, Kecskemét, Hungary

Research Site, Miskolc, Hungary

Research Site, Vác, Hungary

Research Site, Napoli, Italy

Research Site, Roma, Italy

Research Site, Cape Town, South Africa

Research Site, Johannesurg, South Africa

Research Site, Lyttelton Manor, South Africa

Research Site, Parktown, South Africa

Research Site, Tygerberg, South Africa

Research Site, Granada, Spain

Research Site, Madrid, Spain

Research Site, Murcia, Spain

Research Site, Sevilla, Spain

Research Site, Edinburgh, United Kingdom

Research Site, Santiago, A Coruña, Spain

Research Site, Santiago de Compostela, A Coruña, Spain

Research Site, Edmonton, Alberta, Canada

Research Site, Irvine, Ayrshire, United Kingdom

Research Site, Bologna, BO, Italy

Research Site, Stuttgart, Baden-Württemberg, Germany

Research Site, München, Bayern, Germany

Research Site, Cottbus, Brandenburg, Germany

Research Site, Genova, GE, Italy

Research Site, San Sebastián, Guipuzcoa, Spain

Research Site, Frankfurt, Hessen, Germany

Research Site, Winnipeg, Manitoba, Canada

Research Site, Rostock, Mecklenburg-Vorpommern, Germany

Research Site, Bondi Junction, New South Wales, Australia

Research Site, Bay Roberts, Newfoundland and Labrador, Canada

Research Site, Carbonear, Newfoundland and Labrador, Canada

Research Site, St. John's, Newfoundland and Labrador, Canada

Research Site, Hannover, Niedersachsen, Germany

Research Site, Düsseldorf, Nordrhein-Westfalen, Germany

Research Site, MÜNSTER, Nordrhein-Westfalen, Germany

Research Site, Halifax, Nova Scotia, Canada

Research Site, Hamilton, Ontario, Canada

Research Site, London, Ontario, Canada

Research Site, North York, Ontario, Canada

Research Site, Sudbury, Ontario, Canada

Research Site, Thornhill, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Oakville, Ontario, Canada

Research Site, Parma, PR, Italy

Research Site, Parkdale, Prince Edward Island, Canada

Research Site, Courcelette, Quebec, Canada

Research Site, Bracken Ridge, Queensland, Australia

Research Site, Carina Heights, Queensland, Australia

Research Site, Mainz, Rheinland-Pfalz, Germany

Research Site, Halle, Sachsen-Anhalt, Germany

Research Site, Glasgow, Scotland, United Kingdom

Research Site, Adelaide, South Australia, Australia

Research Site, Ashford, South Australia, Australia

Research Site, Wayville, South Australia, Australia

Research Site, Woodville, South Australia, Australia

Research Site, Cardiff, South Wales, United Kingdom

Research Site, Ballarat, Victoria, Australia

Research Site, Malvern, Victoria, Australia

Starting date: May 2004
Last updated: November 9, 2005