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ASTERIX: Low Dose ASA and Nexium

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

November 9, 2005
March 11, 2009
May 2004
Not Provided
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.
Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
September 2005
Not Provided

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
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