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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)

12. juli 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2426

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
      • NSW, Australien
        • Research Site
    • Queensland
      • Caboolture, Queensland, Australien
        • Research Site
      • Carina Heights, Queensland, Australien
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australien
        • Research Site
    • Victoria
      • Ballarat, Victoria, Australien
        • Research Site
      • Box Hill, Victoria, Australien
        • Research Site
      • Geelong, Victoria, Australien
        • Research Site
  • Bulgarien
      • Chirpan, Bulgarien
        • Research Site
      • Pleven, Bulgarien
        • Research Site
      • Rousse, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
      • Varna, Bulgarien
        • 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
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • Research Site
      • Saint- Petersburg, Den Russiske Føderation
        • Research Site
  • Filippinerne
      • Manila, Filippinerne
        • Research Site
      • Quezon City, Filippinerne
        • 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
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • Research Site
    • Arizona
      • Tucson, Arizona, Forenede Stater
        • Research Site
    • California
      • Anaheim, California, Forenede Stater
        • Research Site
      • Lancaster, California, Forenede Stater
        • Research Site
      • Los Angeles, California, Forenede Stater
        • Research Site
      • Orange, California, Forenede Stater
        • Research Site
      • San Carlos, California, Forenede Stater
        • Research Site
      • San Diego, California, Forenede Stater
        • Research Site
    • Connecticut
      • Torrington, Connecticut, Forenede Stater
        • Research Site
    • Florida
      • Boynton Beach, Florida, Forenede Stater
        • Research Site
      • Hollywood, Florida, Forenede Stater
        • Research Site
      • Jacksonville, Florida, Forenede Stater
        • Research Site
      • Jupiter, Florida, Forenede Stater
        • Research Site
      • Miami, Florida, Forenede Stater
        • Research Site
      • New Smyrna Beach, Florida, Forenede Stater
        • Research Site
      • Pembroke Pines, Florida, Forenede Stater
        • Research Site
      • Plantation, Florida, Forenede Stater
        • Research Site
      • South Miami, Florida, Forenede Stater
        • Research Site
      • Tampa, Florida, Forenede Stater
        • Research Site
      • Zephyrhills, Florida, Forenede Stater
        • Research Site
    • Illinois
      • Fulton, Illinois, Forenede Stater
        • Research Site
    • Kansas
      • Wichita, Kansas, Forenede Stater
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater
        • Research Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • Research Site
      • Hollywood, Maryland, Forenede Stater
        • Research Site
      • Prince Frederick, Maryland, Forenede Stater
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, Forenede Stater
        • Research Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater
        • Research Site
    • New Jersey
      • Egg Harbor Township, New Jersey, Forenede Stater
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
        • Research Site
    • New York
      • Great Neck, New York, Forenede Stater
        • Research Site
    • North Carolina
      • Fayetteville, North Carolina, Forenede Stater
        • Research Site
      • Greensboro, North Carolina, Forenede Stater
        • Research Site
      • Jacksonville, North Carolina, Forenede Stater
        • Research Site
      • Winston-salem, North Carolina, Forenede Stater
        • Research Site
    • Ohio
      • Centerville, Ohio, Forenede Stater
        • Research Site
      • Cincinnati, Ohio, Forenede Stater
        • Research Site
      • Dayton, Ohio, Forenede Stater
        • Research Site
    • Oklahoma
      • Guthrie, Oklahoma, Forenede Stater
        • Research Site
      • Oklahoma City, Oklahoma, Forenede Stater
        • Research Site
    • Pennsylvania
      • Harrisburg, Pennsylvania, Forenede Stater
        • Research Site
    • Rhode Island
      • Cranston, Rhode Island, Forenede Stater
        • Research Site
      • Johnston, Rhode Island, Forenede Stater
        • Research Site
    • South Carolina
      • Anderson, South Carolina, Forenede Stater
        • Research Site
      • Simpsonville, South Carolina, Forenede Stater
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater
        • Research Site
    • Texas
      • Houston, Texas, Forenede Stater
        • Research Site
    • Utah
      • Ogden, Utah, Forenede Stater
        • Research Site
    • Virginia
      • Burke, Virginia, Forenede Stater
        • Research Site
      • Chesapeake, Virginia, Forenede Stater
        • Research Site
      • Christiansburg, Virginia, Forenede Stater
        • Research Site
      • Norfolk, Virginia, Forenede Stater
        • Research Site
      • Richmond, Virginia, Forenede Stater
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater
        • Research Site
  • Indonesien
      • Jakarta, Indonesien
        • Research Site
      • Semarang, Indonesien
        • Research Site
      • Surabaya, Indonesien
        • Research Site
      • Yogyakarta, Indonesien
        • Research Site
  • Korea, Republikken
      • Seoul, Korea, Republikken
        • Research Site
    • Kyeonggi-do
      • Seongnam-si, Kyeonggi-do, Korea, Republikken
        • 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
  • Norge
      • Asker, Norge
        • Research Site
      • Bergen, Norge
        • Research Site
      • Elverum, Norge
        • Research Site
      • Gjovik, Norge
        • Research Site
      • Hamar, Norge
        • Research Site
      • Levanger, Norge
        • Research Site
      • Lysaker, Norge
        • Research Site
      • Olesund, Norge
        • Research Site
      • Oslo, Norge
        • Research Site
      • Osteros, Norge
        • Research Site
      • Paradis, Norge
        • Research Site
      • Stavanger, Norge
        • Research Site
      • Tromso, Norge
        • Research Site
  • Polen
      • Bydgoszcz, Polen
        • Research Site
      • Chojnice, Polen
        • Research Site
      • Chrzanow, Polen
        • Research Site
      • Czechowice-dziedzice, Polen
        • Research Site
      • Czestochowa, Polen
        • Research Site
      • Elblog, Polen
        • Research Site
      • Gdansk, Polen
        • Research Site
      • Gdynia, Polen
        • Research Site
      • Ilawa, Polen
        • Research Site
      • Koscierzyna, Polen
        • Research Site
      • Krakow, Polen
        • Research Site
      • Sopot, Polen
        • Research Site
      • Tczew, Polen
        • Research Site
      • Warszawa, Polen
        • 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
  • Rumænien
      • Brasov, Rumænien
        • Research Site
      • Bucharest, Rumænien
        • Research Site
      • Iasi, Rumænien
        • Research Site
      • Satu-mare, Rumænien
        • Research Site
      • Tg. Mures, Rumænien
        • Research Site
  • Slovakiet
      • Banovce Nad Bebravou, Slovakiet
        • Research Site
      • Banska Bysterica, Slovakiet
        • Research Site
      • Brastislava, Slovakiet
        • Research Site
      • Liptovsky Mikulas, Slovakiet
        • Research Site
      • Martin, Slovakiet
        • Research Site
      • Nitra, Slovakiet
        • Research Site
      • Nove Mesto Nad Vahom, Slovakiet
        • Research Site
      • Piestany, Slovakiet
        • Research Site
      • Povazska Bystrica, Slovakiet
        • Research Site
      • Trnava, Slovakiet
        • Research Site
  • Sydafrika
      • Cape Town, Sydafrika
        • Research Site
      • Durban, Sydafrika
        • Research Site
      • Johannesburg, Sydafrika
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
  • Tjekkiet
      • Beroun, Tjekkiet
        • Research Site
      • Brno, Tjekkiet
        • Research Site
      • Liberec, Tjekkiet
        • Research Site
      • Litomerice, Tjekkiet
        • Research Site
      • Ostrava - Trebovice, Tjekkiet
        • Research Site
      • Podborany, Tjekkiet
        • Research Site
      • Poobram, Tjekkiet
        • Research Site
      • Praha 1, Tjekkiet
        • Research Site
      • Praha 4 - Sporilov, Tjekkiet
        • Research Site
      • Praha 6, Tjekkiet
        • Research Site
      • Praha 9, Tjekkiet
        • Research Site
      • Tabor, Tjekkiet
        • Research Site
  • Tyskland
      • Bochum, Tyskland
        • Research Site
      • Dresden, Tyskland
        • Research Site
      • Ludwigshafen, Tyskland
        • Research Site
      • Luedenscheid, Tyskland
        • Research Site
      • Magdeburg, Tyskland
        • Research Site
      • Munchen, Tyskland
        • Research Site
      • Oelde, Tyskland
        • Research Site
      • Potsdam, Tyskland
        • Research Site
      • Rodgau-dudenhofen, Tyskland
        • Research Site
      • Siegen, Tyskland
        • Research Site
      • Wangen, Tyskland
        • Research Site
      • Wolmirstedt, Tyskland
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Placebo én gang dagligt
Eksperimentel: Esomeprazole 40 mg
Medicin: Esomeprazole 40 mg
Esomeprazole 40 mg once daily
Eksperimentel: Esomeprazole 20 mg
Medicin: Esomeprazole 20 mg
Esomeprazole 20 mg once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Tore Lind, MD, PhD, AstraZeneca
  • Ledende efterforsker: James Scheiman, MD, University of Michigan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2007

Primær færdiggørelse (Faktiske)

1. august 2008

Studieafslutning (Faktiske)

1. august 2008

Datoer for studieregistrering

Først indsendt

27. februar 2007

Først indsendt, der opfyldte QC-kriterier

27. februar 2007

Først opslået (Skøn)

1. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D961FC00003
  • EudraCT No. 2006-005073-22

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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