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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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GERD Without Erosive Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AZD0865

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

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

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Countries

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United States Canada Denmark Finland France Germany Italy Norway Sweden United Kingdom

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.

Reference Type DERIVED
PMID: 23831734 (View on PubMed)

Other Identifiers

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D9770C00011

Identifier Type: -

Identifier Source: org_study_id

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