ASTERIX: Low Dose ASA and Nexium

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00251966

D9617C00011

Details and patient eligibility

About

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.

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind