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
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)
2 other identifiers
interventional
2,426
20 countries
189
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
February 13, 2012
CompletedJuly 16, 2012
July 1, 2012
1.5 years
February 27, 2007
August 28, 2009
July 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
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 Outcomes (5)
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
During 26 weeks
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
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.
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.
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Number of Participants With Gastric and/or Duodenal Erosions.
The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Study Arms (3)
Esomeprazole 40 mg
EXPERIMENTALEsomeprazole 40 mg
Esomeprazole 20 mg
EXPERIMENTALEsomeprazole 20 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (189)
Research Site
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Carlos, California, United States
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San Diego, California, United States
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Torrington, Connecticut, United States
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Boynton Beach, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
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New Smyrna Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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Zephyrhills, Florida, United States
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Fulton, Illinois, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Hollywood, Maryland, United States
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Prince Frederick, Maryland, United States
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Brockton, Massachusetts, United States
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Jackson, Mississippi, United States
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Las Vegas, Nevada, United States
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Egg Harbor, New Jersey, United States
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Albuquerque, New Mexico, United States
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Great Neck, New York, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Jacksonville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Centerville, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Guthrie, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Harrisburg, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Johnston, Rhode Island, United States
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Anderson, South Carolina, United States
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Simpsonville, South Carolina, United States
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Knoxville, Tennessee, United States
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Houston, Texas, United States
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Ogden, Utah, United States
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Burke, Virginia, United States
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Chesapeake, Virginia, United States
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Christiansburg, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Milwaukee, Wisconsin, United States
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Capital Federal, Buenos Aires, Argentina
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Loma Hermosa, Buenos Aires, Argentina
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Lomas de Zamora, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires- Argentina, Argentina
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Rosario, Santa Fe Province, Argentina
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Mendoza, Argentina
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Rosario, Argentina
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Caboolture, Queensland, Australia
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Carina Heights, Queensland, Australia
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Adelaide, South Australia, Australia
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Ballarat, Victoria, Australia
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Box Hill, Victoria, Australia
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Geelong, Victoria, Australia
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NSW, Australia
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Chirpan, Bulgaria
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Carbonear, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Hamilton, Ontario, Canada
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Niagara Falls, Ontario, Canada
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North York, Ontario, Canada
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Tillsonburg, Ontario, Canada
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Toronto, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Laval, Canada
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Longueuil, Canada
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Québec, Canada
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Beroun, Czechia
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Brno, Czechia
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Liberec, Czechia
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Litoměřice, Czechia
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Ostrava - Trebovice, Czechia
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Podbořany, Czechia
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Poobram, Czechia
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Prague, Czechia
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Praha 4 - Sporilov, Czechia
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Tábor, Czechia
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Jakobstad, Finland
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Joensuu, Finland
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Mikkeli, Finland
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Tampere, Finland
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Turku, Finland
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Vantaa, Finland
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Bochum, Germany
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Dresden, Germany
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Ludwigshafen, Germany
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Lüdenscheid, Germany
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Magdeburg, Germany
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München, Germany
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Oelde, Germany
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Potsdam, Germany
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Rodgau-dudenhofen, Germany
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Siegen, Germany
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Wangen, Germany
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Wolmirstedt, Germany
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Jakarta, Indonesia
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Semarang, Indonesia
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Surabaya, Indonesia
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Yogyakarta, Indonesia
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México, D.f., Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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D.F, Mexico
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Mexico City, Mexico
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Asker, Norway
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Bergen, Norway
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Elverum, Norway
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Gjøvik, Norway
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Hamar, Norway
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Levanger, Norway
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Lysaker, Norway
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Oslo, Norway
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Osteros, Norway
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Paradis, Norway
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Stavanger, Norway
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Tromsø, Norway
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Ølesund, Norway
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Manila, Philippines
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Quezon City, Philippines
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Bydgoszcz, Poland
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Chojnice, Poland
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Chrzanów, Poland
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Czechowice-Dziedzice, Poland
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Częstochowa, Poland
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Elblog, Poland
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Gdansk, Poland
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Gdynia, Poland
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Iława, Poland
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Kościerzyna, Poland
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Krakow, Poland
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Sopot, Poland
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Tczew, Poland
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Warsaw, Poland
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Angra Do Herosmo, Portugal
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Braga, Portugal
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Castelo Branco, Portugal
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Coimbra, Portugal
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Covilha, Portugal
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Lisbon, Portugal
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Setúbal, Portugal
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Vila Real, Portugal
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Brasov, Brașov County, Romania
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Iași, Iaşi, Romania
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Bucharest, Romania
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Satu Mare, Romania
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Tg. Mures, Romania
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Moscow, Russia
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Saint Petersburg, Russia
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Banska Bysterica, Slovakia
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Bánovce nad Bebravou, Slovakia
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Brastislava, Slovakia
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Liptovský Mikuláš, Slovakia
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Martin, Slovakia
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Nitra, Slovakia
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Nové Mesto nad Váhom, Slovakia
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Piešťany, Slovakia
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Považská Bystrica, Slovakia
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Trnava, Slovakia
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Seongnam-si, Kyeonggi-do, South Korea
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Seoul, South Korea
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Bangkok, Thailand
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Chiang Mai, Thailand
Related Publications (2)
Scheiman JM, Herlitz J, Veldhuyzen van Zanten SJ, Lanas A, Agewall S, Naucler EC, Svedberg LE, Nagy P. Esomeprazole for prevention and resolution of upper gastrointestinal symptoms in patients treated with low-dose acetylsalicylic acid for cardiovascular protection: the OBERON trial. J Cardiovasc Pharmacol. 2013 Mar;61(3):250-7. doi: 10.1097/FJC.0b013e31827cb626.
PMID: 23188121DERIVEDScheiman JM, Devereaux PJ, Herlitz J, Katelaris PH, Lanas A, Veldhuyzen van Zanten S, Naucler E, Svedberg LE. Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON). Heart. 2011 May;97(10):797-802. doi: 10.1136/hrt.2010.217547. Epub 2011 Mar 17.
PMID: 21415072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Not enough patients had peptic ulcer, gastric ulcer, or duodenal ulcer to report the intended primary endpoint of time to peptic ulcer and two secondary endpoints, time to gastric ulcer and time to duodenal ulcer. Percentage used instead.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tore Lind, MD, PhD
AstraZeneca
- PRINCIPAL INVESTIGATOR
James Scheiman, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2007
First Posted
March 1, 2007
Study Start
February 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 16, 2012
Results First Posted
February 13, 2012
Record last verified: 2012-07