ASTERIX: Low Dose ASA and Nexium
Phase 3
Completed
- Conditions
- Gastroesophageal Reflux
- Registration Number
- NCT00251966
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 960
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.
Trial Locations
- Locations (1)
Research Site
🇬🇧Edinburgh, United Kingdom