Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA) (Oberon)

July 12, 2012 updated by: AstraZeneca

A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2426

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Mendoza, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
        • Research Site
      • Loma Hermosa, Buenos Aires, Argentina
        • Research Site
      • Lomas de Zamora, Buenos Aires, Argentina
        • Research Site
    • Buenos Aires- Argentina
      • Buenos Aires, Buenos Aires- Argentina, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
  • Australia
      • NSW, Australia
        • Research Site
    • Queensland
      • Caboolture, Queensland, Australia
        • Research Site
      • Carina Heights, Queensland, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
    • Victoria
      • Ballarat, Victoria, Australia
        • Research Site
      • Box Hill, Victoria, Australia
        • Research Site
      • Geelong, Victoria, Australia
        • Research Site
  • Bulgaria
      • Chirpan, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Rousse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
      • Laval, Canada
        • Research Site
      • Longueuil, Canada
        • Research Site
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • Research Site
      • Carbonear, Newfoundland and Labrador, Canada
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada
        • Research Site
      • Cambridge, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Niagara Falls, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Tillsonburg, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Pointe-claire, Quebec, Canada
        • Research Site
  • Czech Republic
      • Beroun, Czech Republic
        • Research Site
      • Brno, Czech Republic
        • Research Site
      • Liberec, Czech Republic
        • Research Site
      • Litomerice, Czech Republic
        • Research Site
      • Ostrava - Trebovice, Czech Republic
        • Research Site
      • Podborany, Czech Republic
        • Research Site
      • Poobram, Czech Republic
        • Research Site
      • Praha 1, Czech Republic
        • Research Site
      • Praha 4 - Sporilov, Czech Republic
        • Research Site
      • Praha 6, Czech Republic
        • Research Site
      • Praha 9, Czech Republic
        • Research Site
      • Tabor, Czech Republic
        • Research Site
  • Finland
      • Joensuu, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Pietarsaari, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
      • Vantaa, Finland
        • Research Site
  • Germany
      • Bochum, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Luedenscheid, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Oelde, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Rodgau-dudenhofen, Germany
        • Research Site
      • Siegen, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
      • Wolmirstedt, Germany
        • Research Site
  • Indonesia
      • Jakarta, Indonesia
        • Research Site
      • Semarang, Indonesia
        • Research Site
      • Surabaya, Indonesia
        • Research Site
      • Yogyakarta, Indonesia
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
    • Kyeonggi-do
      • Seongnam-si, Kyeonggi-do, Korea, Republic of
        • Research Site
  • Mexico
      • D.F, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
    • D.f.
      • Mexico, D.f., Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
      • Zapopan, Jalisco, Mexico
        • Research Site
  • Norway
      • Asker, Norway
        • Research Site
      • Bergen, Norway
        • Research Site
      • Elverum, Norway
        • Research Site
      • Gjovik, Norway
        • Research Site
      • Hamar, Norway
        • Research Site
      • Levanger, Norway
        • Research Site
      • Lysaker, Norway
        • Research Site
      • Olesund, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Osteros, Norway
        • Research Site
      • Paradis, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Tromso, Norway
        • Research Site
  • Philippines
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Bydgoszcz, Poland
        • Research Site
      • Chojnice, Poland
        • Research Site
      • Chrzanow, Poland
        • Research Site
      • Czechowice-dziedzice, Poland
        • Research Site
      • Czestochowa, Poland
        • Research Site
      • Elblog, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Gdynia, Poland
        • Research Site
      • Ilawa, Poland
        • Research Site
      • Koscierzyna, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Sopot, Poland
        • Research Site
      • Tczew, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Portugal
      • Angra Do Herosmo, Portugal
        • Research Site
      • Braga, Portugal
        • Research Site
      • Castelo Branco, Portugal
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Covilha, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Setubal, Portugal
        • Research Site
      • Vila Real, Portugal
        • Research Site
  • Romania
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Satu-mare, Romania
        • Research Site
      • Tg. Mures, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Saint- Petersburg, Russian Federation
        • Research Site
  • Slovakia
      • Banovce Nad Bebravou, Slovakia
        • Research Site
      • Banska Bysterica, Slovakia
        • Research Site
      • Brastislava, Slovakia
        • Research Site
      • Liptovsky Mikulas, Slovakia
        • Research Site
      • Martin, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Nove Mesto Nad Vahom, Slovakia
        • Research Site
      • Piestany, Slovakia
        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Lancaster, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • San Carlos, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Connecticut
      • Torrington, Connecticut, United States
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States
        • Research Site
      • Hollywood, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Jupiter, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • New Smyrna Beach, Florida, United States
        • Research Site
      • Pembroke Pines, Florida, United States
        • Research Site
      • Plantation, Florida, United States
        • Research Site
      • South Miami, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Zephyrhills, Florida, United States
        • Research Site
    • Illinois
      • Fulton, Illinois, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Hollywood, Maryland, United States
        • Research Site
      • Prince Frederick, Maryland, United States
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Great Neck, New York, United States
        • Research Site
    • North Carolina
      • Fayetteville, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
      • Jacksonville, North Carolina, United States
        • Research Site
      • Winston-salem, North Carolina, United States
        • Research Site
    • Ohio
      • Centerville, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Oklahoma
      • Guthrie, Oklahoma, United States
        • Research Site
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Cranston, Rhode Island, United States
        • Research Site
      • Johnston, Rhode Island, United States
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States
        • Research Site
      • Simpsonville, South Carolina, United States
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site
    • Utah
      • Ogden, Utah, United States
        • Research Site
    • Virginia
      • Burke, Virginia, United States
        • Research Site
      • Chesapeake, Virginia, United States
        • Research Site
      • Christiansburg, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):
  • Aged ≥65 years.
  • Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
  • Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
  • Aged ≥60 years and with stable coronary artery disease.
  • Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion Criteria:

  • Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
  • Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
  • History of peptic ulcer complications such as clinically significant bleeding and/or perforation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo once daily
Experimental: Esomeprazole 40 mg
Drug: Esomeprazole 40 mg
Esomeprazole 40 mg once daily
Experimental: Esomeprazole 20 mg
Drug: Esomeprazole 20 mg
Esomeprazole 20 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
Time Frame: During 26 weeks
The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
During 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
Time Frame: During 26 weeks
The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
During 26 weeks
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
Time Frame: During 26 weeks
The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
During 26 weeks
Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.
Time Frame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.
Time Frame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Number of Participants With Gastric and/or Duodenal Erosions.
Time Frame: The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Tore Lind, MD, PhD, AstraZeneca
  • Principal Investigator: James Scheiman, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961FC00003
  • EudraCT No. 2006-005073-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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