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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00251966




Registration number
NCT00251966
Ethics application status
Date submitted
9/11/2005
Date registered
11/11/2005
Date last updated
12/03/2009

Titles & IDs
Public title
ASTERIX: Low Dose ASA and Nexium
Scientific 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.
Secondary ID [1] 0 0
D9617C00011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Esomeprazole

Treatment: Drugs: Esomeprazole
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Upper GI symptoms

- Erosive oesophagitis

- Malignancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Bondi Junction
Recruitment hospital [2] 0 0
Research Site - Bracken Ridge
Recruitment hospital [3] 0 0
Research Site - Carina Heights
Recruitment hospital [4] 0 0
Research Site - Adelaide
Recruitment hospital [5] 0 0
Research Site - Ashford
Recruitment hospital [6] 0 0
Research Site - Wayville
Recruitment hospital [7] 0 0
Research Site - Woodville
Recruitment hospital [8] 0 0
Research Site - Ballarat
Recruitment hospital [9] 0 0
Research Site - Malvern
Recruitment postcode(s) [1] 0 0
- Bondi Junction
Recruitment postcode(s) [2] 0 0
- Bracken Ridge
Recruitment postcode(s) [3] 0 0
- Carina Heights
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Ashford
Recruitment postcode(s) [6] 0 0
- Wayville
Recruitment postcode(s) [7] 0 0
- Woodville
Recruitment postcode(s) [8] 0 0
- Ballarat
Recruitment postcode(s) [9] 0 0
- Malvern
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Burgas
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Pleven
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Russe
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sofia
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Varna
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Manitoba
Country [8] 0 0
Canada
State/province [8] 0 0
Newfoundland and Labrador
Country [9] 0 0
Canada
State/province [9] 0 0
Nova Scotia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Prince Edward Island
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Germany
State/province [13] 0 0
Baden-Württemberg
Country [14] 0 0
Germany
State/province [14] 0 0
Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Mecklenburg-Vorpommern
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Germany
State/province [18] 0 0
Niedersachsen
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Germany
State/province [19] 0 0
Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen-Anhalt
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Köln
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Germany
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Künzing
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Germany
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Lienen
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Germany
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Ludwigshafen
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Germany
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Lüdenscheid
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Germany
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Münster
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Germany
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Oelde
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Germany
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Paderborn
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Germany
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Potsdam
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Germany
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Ribnitz-Damgarten
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Germany
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Rostock
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Germany
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Siegen
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Germany
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Wangen
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Germany
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Wiesbaden
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Germany
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Wolfenbüttel
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Germany
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Wolmirstedt
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Germany
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Zeven
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Piraeus
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Eger
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Hungary
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Gyula
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Hungary
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Gy¿r
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Hungary
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Kecskemét
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Hungary
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Miskolc
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Hungary
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Vác
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Italy
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BO
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Italy
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GE
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Italy
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PR
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Italy
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Napoli
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Italy
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Roma
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South Africa
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Cape Town
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South Africa
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Johannesurg
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South Africa
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Lyttelton Manor
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South Africa
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Parktown
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South Africa
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Tygerberg
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Spain
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A Coruña
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Spain
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Guipuzcoa
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Spain
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Granada
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Sevilla
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United Kingdom
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Ayrshire
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United Kingdom
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Scotland
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United Kingdom
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South Wales
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United Kingdom
State/province [73] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00251966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Nexium Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00251966