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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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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
State/province [57] 0 0
Napoli
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Italy
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Roma
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South Africa
State/province [59] 0 0
Cape Town
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South Africa
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Johannesurg
Country [61] 0 0
South Africa
State/province [61] 0 0
Lyttelton Manor
Country [62] 0 0
South Africa
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Parktown
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South Africa
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Tygerberg
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Spain
State/province [64] 0 0
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
State/province [72] 0 0
South Wales
Country [73] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00251966