A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
NCT ID: NCT00206284
Last Updated: 2013-01-04
Study Results
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Basic Information
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COMPLETED
PHASE2
1400 participants
INTERVENTIONAL
2004-05-31
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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AZD0865
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Locations
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Alabaster, Alabama, United States
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Huntsville, Alabama, United States
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Tucson, Arizona, United States
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North Little Rock, Arkansas, United States
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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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Wheat Ridge, Colorado, United States
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Manchester, Connecticut, United States
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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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West Palm Beach, Florida, United States
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Zephyrhills, Florida, United States
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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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Chicago, Illinois, United States
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Moline, Illinois, United States
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Rockford, Illinois, United States
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Clive, Iowa, United States
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Overland Park, Kansas, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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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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Picayune, Mississippi, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Butte, Montana, United States
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Willingboro, New Jersey, United States
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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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Canton, Ohio, United States
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Guthrie, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Duncansville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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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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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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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Christiansburg, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Abbotsford, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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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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Lévis, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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St. John's, , Canada
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Aalborg, , Denmark
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Århus C, , 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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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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Alès, , 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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Cologne, , Germany
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Dresden, , Germany
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Görlitz, , 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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Milan, , 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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Malmo, , Sweden
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Mora, , Sweden
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Nyköping, , Sweden
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Östersund, , Sweden
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Säffle, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Sundsvall, , Sweden
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Täby, , Sweden
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Varberg, , Sweden
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Värnamo, , 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
Countries
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References
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Kahrilas PJ, Jonsson A, Denison H, Wernersson B, Hughes N, Howden CW. Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy. Gut. 2014 May;63(5):720-6. doi: 10.1136/gutjnl-2013-304883. Epub 2013 Jul 5.
Other Identifiers
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D9770C00011
Identifier Type: -
Identifier Source: org_study_id
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