ASTERIX: Low Dose ASA and Nexium

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.

Official Title

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.

Conditions

Gastroesophageal Reflux

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• 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:

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

Study Start

May 2004

Eligibility & Criteria

• Ages Eligible for Study: 60 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

960

Contact Details

Australian locations:

• Bondi Junction, New South Wales, Australia
• Bracken Ridge, Queensland, Australia
• Carina Heights, Queensland, Australia
• Adelaide, South Australia, Australia
• Ashford, South Australia, Australia
• Wayville, South Australia, Australia
• Woodville, South Australia, Australia
• Ballarat, Victoria, Australia
• Malvern, Victoria, Australia

Contact AstraZeneca for more details.