Gastroesophageal RefluxPhase 3NCT00251966
ASTERIX: Low Dose ASA and Nexium
A Phase 3 study testing Esomeprazole in people with Gastroesophageal Reflux, run by AstraZeneca at 94 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Esomeprazole
- How many people
- 960 participants
- Where
- 94 sitesin 11 countries
- Study dates
- May 2004to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Upper GI symptoms
- Erosive oesophagitis
- Malignancy
Trial locations and contacts
94 sites in 11 countries.
94 sites in 11 countries
Germany30 sites
Research Site
Cologne
Research Site
Cottbus, Brandenburg
Research Site
Düsseldorf, North Rhine-Westphalia
Research Site
Frankfurt am Main, Hesse
Research Site
Halle, Saxony-Anhalt
Research Site
Hamburg, Free and Hanseatic City of Hamburg
Research Site
Hamburg
Research Site
Hanover, Lower Saxony
Research Site
Herne
Research Site
Künzing
Research Site
Lienen
Research Site
Lüdenscheid
Research Site
Ludwigshafen
Research Site
Mainz, Rhineland-Palatinate
Research Site
München, Bavaria
Research Site
Münster, North Rhine-Westphalia
Research Site
Münster
Research Site
Oelde
Research Site
Paderborn
Research Site
Potsdam
Research Site
Ribnitz-Damgarten
Research Site
Rostock, Mecklenburg-Vorpommern
Research Site
Rostock
Research Site
Siegen
Research Site
Stuttgart, Baden-Wurttemberg
Research Site
Wangen
Research Site
Wiesbaden
Research Site
Wolfenbüttel
Research Site
Wolmirstedt
Research Site
Zeven
Canada16 sites
Research Site
Bay Roberts, Newfoundland and Labrador
Research Site
Carbonear, Newfoundland and Labrador
Research Site
Courcelette, Quebec
Research Site
Edmonton, Alberta
Research Site
Greater Sudbury, Ontario
Research Site
Halifax, Nova Scotia
Research Site
Hamilton, Ontario
Research Site
London, Ontario
Research Site
North York, Ontario
Research Site
Oakville, Ontario
Research Site
Parkdale, Prince Edward Island
Research Site
Québec, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Thornhill, Ontario
Research Site
Toronto, Ontario
Research Site
Winnipeg, Manitoba
Australia9 sites
Research Site
Adelaide, South Australia
Research Site
Ashford, South Australia
Research Site
Ballarat, Victoria
Research Site
Bondi Junction, New South Wales
Research Site
Bracken Ridge, Queensland
Research Site
Carina Heights, Queensland
Research Site
Malvern, Victoria
Research Site
Wayville, South Australia
Research Site
Woodville, South Australia
Hungary8 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Eger
Research Site
Gy¿r
Research Site
Gyula
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Vác
Spain7 sites
Research Site
Granada, Granada
Research Site
Madrid, Madrid
Research Site
Murcia, Murcia
Research Site
San Sebastián, Guipuzcoa
Research Site
Santiago, A Coruña
Research Site
Santiago de Compostela, A Coruña
Research Site
Seville, Sevilla
Bulgaria5 sites
Research Site
Burgas
Research Site
Pleven
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Italy5 sites
Research Site
Bologna, BO
Research Site
Genova, GE
Research Site
Naples
Research Site
Parma, PR
Research Site
Roma, Roma
South Africa5 sites
Research Site
Cape Town
Research Site
Johannesurg
Research Site
Lyttelton Manor
Research Site
Parktown
Research Site
Tygerberg
Greece4 sites
Research Site
Athens
Research Site
Ioannina
Research Site
Piraeus
Research Site
Thessaloniki
United Kingdom4 sites
Research Site
Cardiff, South Wales
Research Site
Edinburgh
Research Site
Glasgow, Scotland
Research Site
Irvine, Ayrshire
About this study
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.
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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Esomeprazole
- Keywords
- Prevention of gastroduodenal lesions, erosive oesophagitis, upper GI symptoms
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startMay 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 960 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Nexium Medical Science Director, MD, Study director, AstraZenecaNeville Yeomans, MD, Principal investigator, Perth Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251966
- Sponsor's protocol ID
- D9617C00011
- Status last verified
- Mar 2009
- First submitted
- 9 Nov 2005
- Last updated
- 12 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00251966
- Acronym / sponsor ID
- D9617C00011
- Conditions
- Gastroesophageal Reflux
- Keywords
- Prevention of gastroduodenal lesions, erosive oesophagitis, upper GI symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Upper GI symptoms
- Erosive oesophagitis
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
Primary outcome
The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA.
1 secondary outcome
LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Nexium Medical Science Director, MD study director
AstraZeneca
Neville Yeomans, MD principal investigator
Perth Medical School
94 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with Gastroesophageal Reflux, run by AstraZeneca at 94 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Germany, Canada, Australia, Hungary, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2009; AzTrials last refreshed its copy on 27 Oct 2026.