ASTERIX: Low Dose ASA and Nexium

Gastroesophageal Reflux Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251966
• Other study ID #: D9617C00011
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: March 11, 2009
• Start date: May 2004
• Est. completion date: September 2005

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Ashford	South Australia
Australia	Research Site	Ballarat	Victoria
Australia	Research Site	Bondi Junction	New South Wales
Australia	Research Site	Bracken Ridge	Queensland
Australia	Research Site	Carina Heights	Queensland
Australia	Research Site	Malvern	Victoria
Australia	Research Site	Wayville	South Australia
Australia	Research Site	Woodville	South Australia
Bulgaria	Research Site	Burgas
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Canada	Research Site	Bay Roberts	Newfoundland and Labrador
Canada	Research Site	Carbonear	Newfoundland and Labrador
Canada	Research Site	Courcelette	Quebec
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	North York	Ontario
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Parkdale	Prince Edward Island
Canada	Research Site	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Thornhill	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Germany	Research Site	Cottbus	Brandenburg
Germany	Research Site	Düsseldorf	Nordrhein-Westfalen
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Halle	Sachsen-Anhalt
Germany	Research Site	Hamburg
Germany	Research Site	Hannover	Niedersachsen
Germany	Research Site	Herne
Germany	Research Site	Köln
Germany	Research Site	Künzing
Germany	Research Site	Lienen
Germany	Research Site	Lüdenscheid
Germany	Research Site	Ludwigshafen
Germany	Research Site	Mainz	Rheinland-Pfalz
Germany	Research Site	München	Bayern
Germany	Research Site	Münster	Nordrhein-Westfalen
Germany	Research Site	Münster
Germany	Research Site	Oelde
Germany	Research Site	Paderborn
Germany	Research Site	Potsdam
Germany	Research Site	Ribnitz-Damgarten
Germany	Research Site	Rostock
Germany	Research Site	Rostock	Mecklenburg-Vorpommern
Germany	Research Site	Siegen
Germany	Research Site	Stuttgart	Baden-Württemberg
Germany	Research Site	Wangen
Germany	Research Site	Wiesbaden
Germany	Research Site	Wolfenbüttel
Germany	Research Site	Wolmirstedt
Germany	Research Site	Zeven
Greece	Research Site	Athens
Greece	Research Site	Ioannina
Greece	Research Site	Piraeus
Greece	Research Site	Thessaloniki
Hong Kong	Research Site	Hong Kong
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Eger
Hungary	Research Site	Gy¿r
Hungary	Research Site	Gyula
Hungary	Research Site	Kecskemét
Hungary	Research Site	Miskolc
Hungary	Research Site	Vác
Italy	Research Site	Bologna	BO
Italy	Research Site	Genova	GE
Italy	Research Site	Napoli
Italy	Research Site	Parma	PR
Italy	Research Site	Roma
South Africa	Research Site	Cape Town
South Africa	Research Site	Johannesurg
South Africa	Research Site	Lyttelton Manor
South Africa	Research Site	Parktown
South Africa	Research Site	Tygerberg
Spain	Research Site	Granada
Spain	Research Site	Madrid
Spain	Research Site	Murcia
Spain	Research Site	San Sebastián	Guipuzcoa
Spain	Research Site	Santiago	A Coruña
Spain	Research Site	Santiago de Compostela	A Coruña
Spain	Research Site	Sevilla
United Kingdom	Research Site	Cardiff	South Wales
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow	Scotland
United Kingdom	Research Site	Irvine	Ayrshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Bulgaria,  Canada,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.