ASTERIX: Low Dose ASA and Nexium

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole

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