ASTERIX: Low Dose ASA and Nexium

A Randomized Double-Blind Placebo-Controlled Study to Assess the Prevention of Low-Dose Acetylsalicylic Acid (ASA) Associated Gastroduodenal Lesions and Upper Gastrointestinal Symptoms in Patients Taking Esomeprazole 20 mg Once Daily for 26 Weeks.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00251966

Enrollment

960

Registered

2005-11-11

Start date

2004-05-31

Completion date

2005-09-30

Last updated

2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Prevention of gastroduodenal lesions, erosive oesophagitis, upper GI symptoms

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.

Interventions

DRUGEsomeprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Australia, Bulgaria, Canada, Germany, Greece, Hong Kong, Hungary, Italy, South Africa, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026