Status:
COMPLETED
ASTERIX: Low Dose ASA and Nexium
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- Upper GI symptoms
- Erosive oesophagitis
- Malignancy
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT00251966
Start Date
May 1 2004
End Date
September 1 2005
Last Update
March 12 2009
Active Locations (94)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Bondi Junction, New South Wales, Australia
2
Research Site
Bracken Ridge, Queensland, Australia
3
Research Site
Carina Heights, Queensland, Australia
4
Research Site
Adelaide, South Australia, Australia