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A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.

3. januar 2013 opdateret af: AstraZeneca

A Randomised, Double-blind, Multicentre Dose-finding Phase IIb Study for up to 8 Weeks' Treatment With AZD0865 25, 50, 75 mg and Esomeprazole 40 mg, Given Orally Once Daily for the Healing of Erosive Esophagitis in Adult Subjects With GERD With Erosive Esophagitis According to the LA Classification in Adult Subjects.

The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg).

The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

1400

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
      • Quebec, Canada
        • Research Site
    • British Columbia
      • Abbotsford, British Columbia, Canada
        • Research Site
      • Vancouver, British Columbia, Canada
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Guelph, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Thornhill, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Levis, Quebec, Canada
        • Research Site
      • Longueuil, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Research Site
  • Danmark
      • Aalborg, Danmark
        • Research Site
      • Birkerød, Danmark
        • Research Site
      • Esbjerg, Danmark
        • Research Site
      • Herning, Danmark
        • Research Site
      • Holbæk, Danmark
        • Research Site
      • Hvidovre, Danmark
        • Research Site
      • Kolding, Danmark
        • Research Site
      • København K, Danmark
        • Research Site
      • København NV, Danmark
        • Research Site
      • Odense, Danmark
        • Research Site
      • Randers, Danmark
        • Research Site
      • Vejle, Danmark
        • Research Site
      • Viborg, Danmark
        • Research Site
      • Århus C, Danmark
        • Research Site
  • Det Forenede Kongerige
      • Ashford, Det Forenede Kongerige
        • Research Site
      • Atherstone, Det Forenede Kongerige
        • Research Site
      • Cambridge, Det Forenede Kongerige
        • Research Site
      • Cheltenham, Det Forenede Kongerige
        • Research Site
      • Coventry, Det Forenede Kongerige
        • Research Site
      • Derby, Det Forenede Kongerige
        • Research Site
      • Dundee, Det Forenede Kongerige
        • Research Site
      • Dunfermline, Det Forenede Kongerige
        • Research Site
      • Epsom, Det Forenede Kongerige
        • Research Site
      • Glasgow, Det Forenede Kongerige
        • Research Site
      • Hamilton, Det Forenede Kongerige
        • Research Site
      • Kent, Det Forenede Kongerige
        • Research Site
      • Lancaster, Det Forenede Kongerige
        • Research Site
      • Manchester, Det Forenede Kongerige
        • Research Site
      • Slough, Det Forenede Kongerige
        • Research Site
      • Somerset, Det Forenede Kongerige
        • Research Site
      • Stafford, Det Forenede Kongerige
        • Research Site
      • Stockport, Det Forenede Kongerige
        • Research Site
      • Telford, Det Forenede Kongerige
        • Research Site
      • Torquay, Det Forenede Kongerige
        • Research Site
      • West Bromwich, Det Forenede Kongerige
        • Research Site
      • West Yorks, Det Forenede Kongerige
        • Research Site
      • Woking, Det Forenede Kongerige
        • Research Site
  • Finland
      • Espoo, Finland
        • Research Site
      • Helsinki, Finland
        • Research Site
      • Lahti, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Pori, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
      • Vantaa, Finland
        • Research Site
  • Forenede Stater
    • Alabama
      • Alabaster, Alabama, Forenede Stater
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      • Huntsville, Alabama, Forenede Stater
        • Research Site
    • Arizona
      • Tucson, Arizona, Forenede Stater
        • Research Site
    • Arkansas
      • North Little Rock, Arkansas, Forenede Stater
        • Research Site
    • California
      • Anaheim, California, Forenede Stater
        • Research Site
      • Cypress, California, Forenede Stater
        • Research Site
      • Garden Grove, California, Forenede Stater
        • Research Site
      • Lancaster, California, Forenede Stater
        • Research Site
      • Los Angeles, California, Forenede Stater
        • Research Site
      • Mission Hills, California, Forenede Stater
        • Research Site
      • Orange, California, Forenede Stater
        • Research Site
      • Rancho Cucamonga, California, Forenede Stater
        • Research Site
      • San Diego, California, Forenede Stater
        • Research Site
      • Torrance, California, Forenede Stater
        • Research Site
    • Colorado
      • Wheat Ridge, Colorado, Forenede Stater
        • Research Site
    • Connecticut
      • Manchester, Connecticut, Forenede Stater
        • Research Site
    • Florida
      • Davie, Florida, Forenede Stater
        • Research Site
      • Gainesville, Florida, Forenede Stater
        • Research Site
      • Hialeah, Florida, Forenede Stater
        • Research Site
      • Jacksonville, Florida, Forenede Stater
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      • Jupiter, Florida, Forenede Stater
        • Research Site
      • Miami, Florida, Forenede Stater
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      • Ocoee, Florida, Forenede Stater
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      • W Palm Beach, Florida, Forenede Stater
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      • Zephyr Hills, Florida, Forenede Stater
        • Research Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater
        • Research Site
      • Austell, Georgia, Forenede Stater
        • Research Site
      • Conyers, Georgia, Forenede Stater
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • Research Site
      • Moline, Illinois, Forenede Stater
        • Research Site
      • Rockford, Illinois, Forenede Stater
        • Research Site
    • Iowa
      • Clive, Iowa, Forenede Stater
        • Research Site
    • Kansas
      • Overland Park, Kansas, Forenede Stater
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater
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      • Shreveport, Louisiana, Forenede Stater
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    • Maryland
      • Annapolis, Maryland, Forenede Stater
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      • Baltimore, Maryland, Forenede Stater
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      • Hollywood, Maryland, Forenede Stater
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      • Laurel, Maryland, Forenede Stater
        • Research Site
      • Towson, Maryland, Forenede Stater
        • Research Site
    • Mississippi
      • Picayune, Mississippi, Forenede Stater
        • Research Site
    • Missouri
      • Jefferson City, Missouri, Forenede Stater
        • Research Site
      • Kansas City, Missouri, Forenede Stater
        • Research Site
    • Montana
      • Butte, Montana, Forenede Stater
        • Research Site
    • New Jersey
      • Willingboro, New Jersey, Forenede Stater
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
        • Research Site
      • Elkin, North Carolina, Forenede Stater
        • Research Site
      • Fayetteville, North Carolina, Forenede Stater
        • Research Site
      • Greensboro, North Carolina, Forenede Stater
        • Research Site
      • Greenville, North Carolina, Forenede Stater
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      • High Point, North Carolina, Forenede Stater
        • Research Site
      • Raleigh, North Carolina, Forenede Stater
        • Research Site
    • Ohio
      • Canton, Ohio, Forenede Stater
        • Research Site
    • Oklahoma
      • Guthrie, Oklahoma, Forenede Stater
        • Research Site
      • Oklahoma City, Oklahoma, Forenede Stater
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Research Site
    • South Carolina
      • Anderson, South Carolina, Forenede Stater
        • Research Site
      • Georgetown, South Carolina, Forenede Stater
        • Research Site
      • Mt Pleasant, South Carolina, Forenede Stater
        • Research Site
      • Simpsonville, South Carolina, Forenede Stater
        • Research Site
    • Tennessee
      • Bristol, Tennessee, Forenede Stater
        • Research Site
      • Chattanooga, Tennessee, Forenede Stater
        • Research Site
      • Jackson, Tennessee, Forenede Stater
        • Research Site
      • Knoxville, Tennessee, Forenede Stater
        • Research Site
      • Nashville, Tennessee, Forenede Stater
        • Research Site
    • Texas
      • Austin, Texas, Forenede Stater
        • Research Site
      • Dallas, Texas, Forenede Stater
        • Research Site
      • Houston, Texas, Forenede Stater
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    • Utah
      • Ogden, Utah, Forenede Stater
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      • Salt Lake City, Utah, Forenede Stater
        • Research Site
    • Virginia
      • Christiansburg, Virginia, Forenede Stater
        • Research Site
      • Norfolk, Virginia, Forenede Stater
        • Research Site
      • Richmond, Virginia, Forenede Stater
        • Research Site
    • Washington
      • Spokane, Washington, Forenede Stater
        • Research Site
      • Tacoma, Washington, Forenede Stater
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater
        • Research Site
  • Frankrig
      • Ales, Frankrig
        • Research Site
      • Angers, Frankrig
        • Research Site
      • Beausoleil, Frankrig
        • Research Site
      • Bordeaux, Frankrig
        • Research Site
      • Caen, Frankrig
        • Research Site
      • Cannes La Bocca, Frankrig
        • Research Site
      • Choisy Le Roi, Frankrig
        • Research Site
      • Dreux, Frankrig
        • Research Site
      • Hazebrouck, Frankrig
        • Research Site
      • Issoire, Frankrig
        • Research Site
      • Marseille, Frankrig
        • Research Site
      • Narbonne, Frankrig
        • Research Site
      • Paris, Frankrig
        • Research Site
      • Saint Quentin, Frankrig
        • Research Site
      • Talence, Frankrig
        • Research Site
      • Vitry Sur Seine, Frankrig
        • Research Site
  • Italien
      • Bologna, Italien
        • Research Site
      • Brescia, Italien
        • Research Site
      • Genova, Italien
        • Research Site
      • Mestre, Italien
        • Research Site
      • Milano, Italien
        • Research Site
      • Napoli, Italien
        • Research Site
      • Palermo, Italien
        • Research Site
      • Parma, Italien
        • Research Site
      • Pisa, Italien
        • Research Site
      • Roma, Italien
        • Research Site
  • Norge
      • Bergen, Norge
        • Research Site
      • Bodø, Norge
        • Research Site
      • Drammen, Norge
        • Research Siteq
      • Gjøvik, Norge
        • Research Site
      • Levanger, Norge
        • Research Site
      • Nesttun, Norge
        • Research Site
      • Oslo, Norge
        • Research Site
      • Stavanger, Norge
        • Research Site
      • Tromsø, Norge
        • Research Site
      • Trondheim, Norge
        • Research Site
  • Sverige
      • Karlskrona, Sverige
        • Research Site
      • Kristianstad, Sverige
        • Research Site
      • Kungälv, Sverige
        • Research Site
      • Malmö, Sverige
        • Research Site
      • Mora, Sverige
        • Research Site
      • Nyköping, Sverige
        • Research Site
      • Skövde, Sverige
        • Research Site
      • Stockholm, Sverige
        • Research Site
      • Sundsvall, Sverige
        • Research Site
      • Säffle, Sverige
        • Research Site
      • Täby, Sverige
        • Research Site
      • Varberg, Sverige
        • Research Site
      • Värnamo, Sverige
        • Research Site
      • Östersund, Sverige
        • Research Siteq
  • Tyskland
      • Berlin, Tyskland
        • Research Site
      • Celle, Tyskland
        • Research Site
      • Dresden, Tyskland
        • Research Site
      • Görlitz, Tyskland
        • Research Site
      • Köln, Tyskland
        • Research Site
      • Leipzig, Tyskland
        • Research Site
      • Ludwigshafen, Tyskland
        • Research Site
      • Magdeburg, Tyskland
        • Research Site
      • Mainz, Tyskland
        • Research Site
      • München, Tyskland
        • Research Site
      • Oelde, Tyskland
        • Research Site
      • Potsdam, Tyskland
        • Research Site
      • Ribnitz-Damgarten, 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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone.
  • Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1.
  • Erosive esophagitis according to LA classification Grade A, B, C or D, at the visit 1 endoscopy.
  • Have provided Informed consent.

Exclusion Criteria:

Subjects with current or historical evidence of the following conditions are excluded from the study:

  • Esophageal stricture.
  • Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
  • Systemic Sclerosis (scleroderma).
  • Irritable Bowel Syndrome (IBS), i.e. upper abdominal discomfort or pain that in the opinion of the Investigator is likely to be due to IBS or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools.
  • Inflammatory bowel disease.
  • Zollinger-Ellison syndrome.
  • Gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months

Subjects with i) history of significant or ii) current significant or unstable:

  • Cardiovascular diseases or cardiac chest pain.
  • Cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus.
  • Diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable.
  • Pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study.
  • Malignant disease (except for minor superficial skin disease).
  • Generalised bleeding disorders.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Healing of erosive esophagitis at 4 weeks.

Sekundære resultatmål

Resultatmål
Livskvaliteten ved refluks og dyspepsi (QOLRAD).
Patientrapporterede symptomer.
Efterforsker-rapporterede symptomer.
Populationsfarmakokinetik (PK). Areal under koncentration-tid-kurven (AUC) og den orale clearance beregnet ved dosis/AUC (CL/F).
pH-overvågning.
Histologi.
Sikkerhed (Uønskede hændelser, Laboratorievariable, BP, puls, EKG og fysisk undersøgelse).
Healing of erosive esophagitis at 2 and 8 weeks.

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

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. maj 2004

Studieafslutning (Faktiske)

1. marts 2005

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

20. september 2005

Først opslået (Skøn)

21. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D9770C00012

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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