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ASTERIX: Low Dose ASA and Nexium

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroesophageal Reflux focused on measuring Prevention of gastroduodenal lesions, erosive oesophagitis, upper GI symptoms

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

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 Outcome Measures

LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.

Full Information

First Posted
November 9, 2005
Last Updated
March 11, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00251966
Brief Title
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

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Prevention of gastroduodenal lesions, erosive oesophagitis, upper GI symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
960 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Neville Yeomans, MD
Organizational Affiliation
Perth Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Bondi Junction
State/Province
New South Wales
Country
Australia
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Research Site
City
Bracken Ridge
State/Province
Queensland
Country
Australia
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Carina Heights
State/Province
Queensland
Country
Australia
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Adelaide
State/Province
South Australia
Country
Australia
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Ashford
State/Province
South Australia
Country
Australia
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Wayville
State/Province
South Australia
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Australia
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Woodville
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South Australia
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Australia
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Ballarat
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Victoria
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Australia
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Malvern
State/Province
Victoria
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Australia
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Burgas
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Bulgaria
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City
Pleven
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Bulgaria
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Russe
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Edmonton
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Alberta
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Canada
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Winnipeg
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Manitoba
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Canada
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Bay Roberts
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Newfoundland and Labrador
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Canada
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Carbonear
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Newfoundland and Labrador
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Canada
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St. John's
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Newfoundland and Labrador
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Canada
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Halifax
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Nova Scotia
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Canada
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Hamilton
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Ontario
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Canada
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London
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Ontario
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Canada
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North York
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Ontario
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Canada
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Oakville
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Ontario
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Canada
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Sudbury
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Ontario
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Canada
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Thornhill
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Parkdale
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Prince Edward Island
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Canada
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Courcelette
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Quebec
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Canada
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Quebec
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Canada
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Stuttgart
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Baden-Württemberg
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Germany
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München
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Bayern
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Germany
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Cottbus
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Brandenburg
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Germany
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Frankfurt
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Hessen
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Germany
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Rostock
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Mecklenburg-Vorpommern
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Germany
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Hannover
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Niedersachsen
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Germany
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Düsseldorf
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Nordrhein-Westfalen
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Germany
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Münster
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Nordrhein-Westfalen
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Germany
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Mainz
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Rheinland-Pfalz
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Germany
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Halle
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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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Germany
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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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Greece
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Hong Kong
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Hong Kong
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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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Hungary
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Bologna
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BO
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Italy
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Genova
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GE
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Italy
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Parma
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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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Italy
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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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South Africa
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Santiago de Compostela
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A Coruña
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Spain
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Santiago
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A Coruña
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Spain
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San Sebastián
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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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Spain
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Irvine
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Ayrshire
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United Kingdom
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Glasgow
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Scotland
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United Kingdom
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Cardiff
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South Wales
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United Kingdom
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Edinburgh
Country
United Kingdom

12. IPD Sharing Statement

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ASTERIX: Low Dose ASA and Nexium

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