Gastric UlcerPhase 3OberonNCT00441727

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)

A Phase 3 study testing Esomeprazole 40 mg and Esomeprazole 20 mg in people with Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 189 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastric Ulcer, Duodenal Ulcer
What is being tested?: Esomeprazole 40 mg and Esomeprazole 20 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,426 participants
Where: 189 sitesin 20 countries
Study dates: Feb 2007to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

189 sites in 20 countries.

Country

City, postcode or hospital

189 sites in 20 countries

United States55 sites

Research Site
Albuquerque, New Mexico
Research Site
Anaheim, California
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Anderson, South Carolina
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Baltimore, Maryland
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Birmingham, Alabama
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Boynton Beach, Florida
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Brockton, Massachusetts
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Burke, Virginia
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Centerville, Ohio
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Chesapeake, Virginia
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Christiansburg, Virginia
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Cincinnati, Ohio
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Cranston, Rhode Island
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Dayton, Ohio
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Egg Harbor, New Jersey
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Fayetteville, North Carolina
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Fulton, Illinois
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Great Neck, New York
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Greensboro, North Carolina
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Guthrie, Oklahoma
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Harrisburg, Pennsylvania
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Hollywood, Florida
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Hollywood, Maryland
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Houston, Texas
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Jackson, Mississippi
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Jacksonville, Florida
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Jacksonville, North Carolina
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Johnston, Rhode Island
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Jupiter, Florida
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Knoxville, Tennessee
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Lancaster, California
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Las Vegas, Nevada
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Los Angeles, California
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Miami, Florida
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Milwaukee, Wisconsin
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New Smyrna Beach, Florida
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Norfolk, Virginia
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Ogden, Utah
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Oklahoma City, Oklahoma
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Orange, California
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Pembroke Pines, Florida
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Plantation, Florida
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Prince Frederick, Maryland
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Richmond, Virginia
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San Carlos, California
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San Diego, California
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Shreveport, Louisiana
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Simpsonville, South Carolina
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South Miami, Florida
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Tampa, Florida
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Torrington, Connecticut
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Tucson, Arizona
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Wichita, Kansas
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Winston-Salem, North Carolina
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Zephyrhills, Florida

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Canada17 sites

Research Site
Bay Roberts, Newfoundland and Labrador
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Brampton, Ontario
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Calgary, Alberta
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Cambridge, Ontario
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Carbonear, Newfoundland and Labrador
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Edmonton, Alberta
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Hamilton, Ontario
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Laval
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Longueuil
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Mount Pearl, Newfoundland and Labrador
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Niagara Falls, Ontario
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North York, Ontario
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Pointe-Claire, Quebec
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Québec
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St. John's, Newfoundland and Labrador
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Tillsonburg, Ontario
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Toronto, Ontario

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Poland14 sites

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Bydgoszcz
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Chojnice
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Chrzanów
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Czechowice-Dziedzice
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Częstochowa
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Elblog
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Gdansk
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Gdynia
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Iława
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Kościerzyna
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Krakow
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Sopot
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Tczew
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Warsaw

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Norway13 sites

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Asker
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Bergen
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Elverum
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Gjøvik
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Hamar
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Levanger
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Lysaker
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Ølesund
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Oslo
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Osteros
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Paradis
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Stavanger
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Tromsø

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Germany12 sites

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Bochum
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Dresden
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Lüdenscheid
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Ludwigshafen
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Magdeburg
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München
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Oelde
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Potsdam
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Rodgau-dudenhofen
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Siegen
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Wangen
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Wolmirstedt

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Czechia10 sites

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Beroun
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Brno
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Liberec
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Litoměřice
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Podbořany
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Poobram
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Prague
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Praha 4 - Sporilov
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Slovakia10 sites

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Bánovce nad Bebravou
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Banska Bysterica
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Brastislava
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Liptovský Mikuláš
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Martin
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Nitra
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Nové Mesto nad Váhom
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Piešťany
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Považská Bystrica
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Trnava

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Portugal8 sites

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Angra Do Herosmo
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Braga
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Castelo Branco
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Coimbra
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Covilha
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Lisbon
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Setúbal
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Vila Real

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Argentina7 sites

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Buenos Aires, Buenos Aires- Argentina
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Capital Federal, Buenos Aires
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Loma Hermosa, Buenos Aires
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Lomas de Zamora, Buenos Aires
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Mendoza
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Rosario, Santa Fe Province
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Rosario

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Australia7 sites

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Adelaide, South Australia
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Ballarat, Victoria
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Box Hill, Victoria
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Caboolture, Queensland
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Carina Heights, Queensland
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Geelong, Victoria
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NSW

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Finland6 sites

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Jakobstad
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Joensuu
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Mikkeli
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Tampere
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Turku
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Vantaa

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Bulgaria5 sites

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Chirpan
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Pleven
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Rousse
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Sofia
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Mexico5 sites

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Guadalajara, Jalisco
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Romania5 sites

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Indonesia4 sites

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South Africa3 sites

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Philippines2 sites

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Russia2 sites

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South Korea2 sites

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Thailand2 sites

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About this study

Official title: 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)

Conditions: Gastric Ulcer, Duodenal Ulcer
Being tested: Esomeprazole 40 mg, Esomeprazole 20 mg, Placebo
Keywords: Peptic ulcer, low-dose ASA
Medical subject headings: Stomach Ulcer, Duodenal Ulcer, Peptic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Esomeprazole 40 mgDrug
Esomeprazole 40 mg once daily
Esomeprazole 20 mgDrug
Esomeprazole 20 mg once daily
PlaceboDrug
Placebo once daily

Study groups in NCT00441727
Study group	Role	What they receive
Esomeprazole 40 mg	Experimental	Esomeprazole 40 mg Receives: Drug: Esomeprazole 40 mg
Esomeprazole 20 mg	Experimental	Esomeprazole 20 mg Receives: Drug: Esomeprazole 20 mg
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During 26 weeks

Secondary outcomes (5)

Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
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.
Measured: During 26 weeks
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
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.
Measured: 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 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.
Measured: 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 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.
Measured: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Number of Participants With Gastric and/or Duodenal Erosions.
Measured: The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Aug 2008

First posted1 Mar 2007 (estimated)
Study startFeb 2007
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gastric UlcerStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00441727
Sponsor's protocol ID: D961FC00003
Other IDs: EudraCT No. 2006-005073-22
Acronym: Oberon
Status last verified: Jul 2012
First submitted: 27 Feb 2007
Last updated: 16 Jul 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23188121
Scheiman 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.
PubMed 21415072

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
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To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
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Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
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SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
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All Gastric Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT00441727
Acronym / sponsor ID: Oberon / D961FC00003
Conditions: Gastric Ulcer, Duodenal Ulcer
Keywords: Peptic ulcer, low-dose ASA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,426 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 1 Mar 2007 (estimated)
Results: Posted 13 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Esomeprazole 40 mg	Experimental	Drug: Esomeprazole 40 mgEsomeprazole 40 mg
Esomeprazole 20 mg	Experimental	Drug: Esomeprazole 20 mgEsomeprazole 20 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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.

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 40 mgEsomeprazole 40 mg once daily	Drug	Esomeprazole 40 mg
Esomeprazole 20 mgEsomeprazole 20 mg once daily	Drug	Esomeprazole 20 mg
PlaceboPlacebo once daily	Drug	Placebo

Primary outcome

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.

5 secondary outcomes

Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
Time frame: During 26 weeks
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
Time frame: 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.
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.
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.

Results and safety

Results posted to the registry on 13 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esomeprazole 40	817	711
Esomeproazole 20	804	686
Placebo	805	637

Primary outcome: Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).

Time frame: During 26 weeks. Number. Unit: percentage of participants

Measure	Esomeprazole 40 n = 817	Esomeproazole 20 n = 804	Placebo n = 805
Value	1.35	1	6.58

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole 40	46 of ?	32 of ?	Not reported
Esomeproazole 20	40 of ?	42 of ?	Not reported
Placebo	35 of ?	31 of ?	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23188121Scheiman 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.
Derived from this study: PubMed 21415072Scheiman 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.

Related trials for Gastric Ulcer

Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 4
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Ulcers, Gastric
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes

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.

Tore Lind, MD, PhD study director

AstraZeneca

James Scheiman, MD principal investigator

University of Michigan

189 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esomeprazole 40 mg and Esomeprazole 20 mg in people with Gastric Ulcer and Duodenal Ulcer, run by AstraZeneca at 189 sites in 20 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 6 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 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Canada, Poland, Norway, Germany and 15 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 13 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). (time frame: During 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00441727, which also lists 2 linked publications.

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 16 Jul 2012.