ASTERIX: Low Dose ASA and Nexium

Phase 3CompletedNCT00251966

AstraZeneca960 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

960

Conditions

Gastroesophageal Reflux

Interventions

EsomeprazoleDRUG

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (94)

Outcomes

Primary Outcomes

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 Outcomes

LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.

Data from ClinicalTrials.gov

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Research Site

Bondi Junction, New South Wales, Australia

Research Site

Bracken Ridge, Queensland, Australia

Research Site

Carina Heights, Queensland, Australia

Research Site

Adelaide, South Australia, Australia

Research Site

Ashford, South Australia, Australia

Research Site

Wayville, South Australia, Australia

Research Site

Woodville, South Australia, Australia

Research Site

Ballarat, Victoria, Australia

Research Site

Malvern, Victoria, Australia

Research Site

Burgas, Bulgaria

...and 84 more locations