A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
January 3, 2013 updated by: AstraZeneca
A 4-week, Randomised, Double-blind, Multicentre, Dose-finding Phase IIb Study With AZD0865 25, 50, 75 mg and Esomeprazole 20 mg, Given Orally Once Daily for the Treatment of GERD Without 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 20 mg and to evaluate the safety and tolerability of AZD0865.
Study Overview
Study Type
Interventional
Enrollment
1400
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada
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St. John's, Canada
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British Columbia
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Abbotsford, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Levis, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
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Aalborg, Denmark
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Birkerød, Denmark
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Esbjerg, Denmark
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Herning, Denmark
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Holbæk, Denmark
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Hvidovre, Denmark
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Kolding, Denmark
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København K, Denmark
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København NV, Denmark
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Odense, Denmark
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Randers, Denmark
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Vejle, Denmark
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Viborg, Denmark
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Århus C, Denmark
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Espoo, Finland
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Helsinki, Finland
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Lahti, Finland
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Mikkeli, Finland
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Pori, Finland
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Tampere, Finland
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Turku, Finland
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Vantaa, Finland
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Ales, France
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Angers, France
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Beausoleil, France
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Bordeaux, France
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Caen, France
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Cannes La Bocca, France
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Choisy Le Roi, France
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Dreux, France
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Hazebrouck, France
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Issoire, France
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Marseille, France
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Narbonne, France
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Paris, France
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Saint Quentin, France
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Talence, France
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Vitry Sur Seine, France
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Berlin, Germany
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Celle, Germany
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Dresden, Germany
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Görlitz, Germany
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Köln, Germany
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Leipzig, Germany
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Ludwigshafen, Germany
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Magdeburg, Germany
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Mainz, Germany
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München, Germany
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Oelde, Germany
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Potsdam, Germany
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Ribnitz-Damgarten, Germany
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Wolmirstedt, Germany
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Bologna, Italy
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Brescia, Italy
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Genova, Italy
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Mestre, Italy
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Milano, Italy
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Napoli, Italy
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Palermo, Italy
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Parma, Italy
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Pisa, Italy
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Roma, Italy
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Bergen, Norway
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Bodø, Norway
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Drammen, Norway
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Gjøvik, Norway
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Levanger, Norway
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Nesttun, Norway
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Oslo, Norway
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Stavanger, Norway
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Tromsø, Norway
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Trondheim, Norway
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Karlskrona, Sweden
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Kristianstad, Sweden
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Kungälv, Sweden
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Malmö, Sweden
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Mora, Sweden
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Nyköping, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Säffle, Sweden
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Täby, Sweden
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Varberg, Sweden
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Värnamo, Sweden
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Östersund, Sweden
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Ashford, United Kingdom
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Atherstone, United Kingdom
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Cambridge, United Kingdom
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Cheltenham, United Kingdom
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Coventry, United Kingdom
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Derby, United Kingdom
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Dundee, United Kingdom
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Dunfermline, United Kingdom
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Epsom, United Kingdom
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Glasgow, United Kingdom
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Hamilton, United Kingdom
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Kent, United Kingdom
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Lancaster, United Kingdom
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Manchester, United Kingdom
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Slough, United Kingdom
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Somerset, United Kingdom
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Stafford, United Kingdom
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Stockport, United Kingdom
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Telford, United Kingdom
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Torquay, United Kingdom
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West Bromwich, United Kingdom
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West Yorks, United Kingdom
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Woking, United Kingdom
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Alabama
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Alabaster, Alabama, United States
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Huntsville, Alabama, United States
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Arizona
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Tucson, Arizona, United States
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Arkansas
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North Little Rock, Arkansas, United States
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California
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Anaheim, California, United States
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Cypress, California, United States
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Garden Grove, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Orange, California, United States
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Rancho Cucamonga, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Colorado
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Wheat Ridge, Colorado, United States
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Connecticut
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Manchester, Connecticut, United States
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Florida
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Davie, Florida, United States
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Gainesville, Florida, United States
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Hialeah, 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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Ocoee, Florida, United States
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W Palm Beach, Florida, United States
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Zephyr Hills, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Austell, Georgia, United States
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Conyers, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Moline, Illinois, United States
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Rockford, Illinois, United States
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Iowa
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Clive, Iowa, United States
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Kansas
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Overland Park, Kansas, United States
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Louisiana
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Maryland
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Hollywood, Maryland, United States
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Laurel, Maryland, United States
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Towson, Maryland, United States
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Mississippi
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Picayune, Mississippi, United States
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Missouri
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Montana
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Butte, Montana, United States
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New Jersey
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Willingboro, New Jersey, United States
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North Carolina
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Charlotte, North Carolina, United States
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Elkin, North Carolina, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Ohio
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Canton, Ohio, United States
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Oklahoma
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Guthrie, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Pennsylvania
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Duncansville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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South Carolina
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Anderson, South Carolina, United States
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Georgetown, South Carolina, United States
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Mt Pleasant, South Carolina, United States
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Simpsonville, South Carolina, United States
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Tennessee
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Utah
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Virginia
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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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Washington
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Have an absence of mucosal breaks in the esophagus, as defined by the LA classification, 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:
- Erosive esophagitis.
- Esophageal columnar metaplasia (Barrett's esophagus) of 1.0 cm or greater.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time to sustained absence of patient-reported heartburn.
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Secondary Outcome Measures
Outcome Measure |
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The Quality of Life in Reflux and Dyspepsia (QOLRAD).
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Patient-reported symptoms.
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Investigator-reported symptoms.
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Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
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pH monitoring.
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Histology.
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Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
September 15, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
January 4, 2013
Last Update Submitted That Met QC Criteria
January 3, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D9770C00011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.