A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
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.
1 other identifier
interventional
1,400
10 countries
202
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2004
Shorter than P25 for phase_2
202 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedJanuary 4, 2013
January 1, 2013
September 15, 2005
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to sustained absence of patient-reported heartburn.
Secondary Outcomes (7)
The Quality of Life in Reflux and Dyspepsia (QOLRAD).
Patient-reported symptoms.
Investigator-reported symptoms.
Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
pH monitoring.
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (202)
Research Site
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
Related Publications (1)
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.
PMID: 23831734DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 21, 2005
Study Start
May 1, 2004
Study Completion
April 1, 2005
Last Updated
January 4, 2013
Record last verified: 2013-01