Clinical trial NCT00251966: ASTERIX: Low Dose ASA and Nexium
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Prevention of gastroduodenal lesions
erosive oesophagitis
upper GI symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 960
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: 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:
measure: LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.
Other outcomes:
Locations:
city: Bondi Junction
country: Australia
facility: Research Site
state: New South Wales
city: Bracken Ridge
country: Australia
facility: Research Site
state: Queensland
city: Carina Heights
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Ashford
country: Australia
facility: Research Site
state: South Australia
city: Wayville
country: Australia
facility: Research Site
state: South Australia
city: Woodville
country: Australia
facility: Research Site
state: South Australia
city: Ballarat
country: Australia
facility: Research Site
state: Victoria
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Burgas
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Bay Roberts
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Carbonear
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
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state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
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state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Thornhill
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Parkdale
country: Canada
facility: Research Site
state: Prince Edward Island
city: Courcelette
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
state: Baden-Württemberg
city: München
country: Germany
facility: Research Site
state: Bayern
city: Cottbus
country: Germany
facility: Research Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: Research Site
state: Hessen
city: Rostock
country: Germany
facility: Research Site
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: Research Site
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Research Site
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Hamburg
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Künzing
country: Germany
facility: Research Site
city: Lienen
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Lüdenscheid
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Oelde
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Ribnitz-Damgarten
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Wolfenbüttel
country: Germany
facility: Research Site
city: Wolmirstedt
country: Germany
facility: Research Site
city: Zeven
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Gy¿r
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Vác
country: Hungary
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Genova
country: Italy
facility: Research Site
state: GE
city: Parma
country: Italy
facility: Research Site
state: PR
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Johannesurg
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Parktown
country: South Africa
facility: Research Site
city: Tygerberg
country: South Africa
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
state: A Coruña
city: Santiago
country: Spain
facility: Research Site
state: A Coruña
city: San Sebastián
country: Spain
facility: Research Site
state: Guipuzcoa
city: Granada
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Irvine
country: United Kingdom
facility: Research Site
state: Ayrshire
city: Glasgow
country: United Kingdom
facility: Research Site
state: Scotland
city: Cardiff
country: United Kingdom
facility: Research Site
state: South Wales
city: Edinburgh
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Science Director, MD
role: STUDY_DIRECTOR
affiliation: Perth Medical School
name: Neville Yeomans, MD
role: PRINCIPAL_INVESTIGATOR
References: