ASTERIX: Low Dose ASA and Nexium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251966
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : March 12, 2009
Information provided by:

November 9, 2005
November 11, 2005
March 12, 2009
May 2004
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The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA.
Same as current
Complete list of historical versions of study NCT00251966 on Archive Site
LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.
Same as current
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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.
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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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Gastroesophageal Reflux
Drug: Esomeprazole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2005
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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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Bulgaria,   Canada,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   South Africa,   Spain,   United Kingdom
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Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
Principal Investigator: Neville Yeomans, MD Perth Medical School
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP