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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA. |
| Measure | Description | Time Frame |
|---|---|---|
| LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Nexium Medical Science Director, MD | AstraZeneca | Study Director |
| Neville Yeomans, MD | Perth Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bondi Junction | New South Wales | Australia | |||
| Research Site |
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| Bracken Ridge |
| Queensland |
| Australia |
| Research Site | Carina Heights | Queensland | Australia |
| 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 | Ballarat | Victoria | Australia |
| Research Site | Malvern | Victoria | Australia |
| Research Site | Burgas | Bulgaria |
| Research Site | Pleven | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| 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 | Halifax | Nova Scotia | Canada |
| Research Site | Greater Sudbury | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | North York | Ontario | Canada |
| Research Site | Oakville | Ontario | Canada |
| Research Site | Thornhill | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Parkdale | Prince Edward Island | Canada |
| Research Site | Courcelette | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Stuttgart | Baden-Wurttemberg | Germany |
| Research Site | München | Bavaria | Germany |
| Research Site | Cottbus | Brandenburg | Germany |
| Research Site | Hamburg | Free and Hanseatic City of Hamburg | Germany |
| Research Site | Frankfurt am Main | Hesse | Germany |
| Research Site | Hanover | Lower Saxony | Germany |
| Research Site | Rostock | Mecklenburg-Vorpommern | Germany |
| Research Site | Düsseldorf | North Rhine-Westphalia | Germany |
| Research Site | Münster | North Rhine-Westphalia | Germany |
| Research Site | Mainz | Rhineland-Palatinate | Germany |
| Research Site | Halle | Saxony-Anhalt | Germany |
| Research Site | Cologne | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Herne | Germany |
| Research Site | Künzing | Germany |
| Research Site | Lienen | Germany |
| Research Site | Ludwigshafen | Germany |
| Research Site | Lüdenscheid | 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 | Gyula | Hungary |
| Research Site | Gy¿r | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Vác | Hungary |
| Research Site | Bologna | BO | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Parma | PR | Italy |
| Research Site | Roma | Roma | Italy |
| Research Site | Naples | 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 | Santiago | A Coruña | Spain |
| Research Site | Santiago de Compostela | A Coruña | Spain |
| Research Site | Granada | Granada | Spain |
| Research Site | San Sebastián | Guipuzcoa | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | Murcia | Murcia | Spain |
| Research Site | Seville | Sevilla | Spain |
| Research Site | Irvine | Ayrshire | United Kingdom |
| Research Site | Glasgow | Scotland | United Kingdom |
| Research Site | Cardiff | South Wales | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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