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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00272701 |
The purpose of this study is to assess how PPI treated GERD patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.
Condition | Intervention | Phase |
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Gastroesophageal Reflux Disease |
Drug: Esomeprazole Drug: Other PPI marketed in Sweden |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised, Open, Phase IV, Parallel Group Multicentre Study to Evaluate a Change of Management in Gastroesophageal Reflux Disease (GERD) Patients by Treatment With Esomeprazole 40 mg or Any Other Proton Pump Inhibitor (PPI), After Initial Treatment Failure, in Ordinary Clinical Practice During 4 Weeks. |
Estimated Enrollment: | 450 |
Study Start Date: | December 2005 |
Study Completion Date: | February 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)
Exclusion Criteria:
Sweden | |
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Akersberga, Sweden | |
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Arlov, Sweden | |
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Boras, Sweden | |
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Bromma, Sweden | |
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Bromolla, Sweden | |
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DALBY, Sweden | |
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Harnosand, Sweden | |
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Helsingborg, Sweden | |
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Jarfalla, Sweden | |
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Kil, Sweden | |
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Knäred, Sweden | |
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Ludvika, Sweden | |
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Lund, Sweden | |
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Malmo, Sweden | |
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Pitea, Sweden | |
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Partille, Sweden | |
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Solna, Sweden | |
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Stockholm, Sweden | |
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Täby, Sweden | |
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Trollhättan, Sweden | |
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Varberg, Sweden | |
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SANDVIKEN, Sweden | |
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Vasteras, Sweden | |
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Djursholm, Sweden | |
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Enskededalen, Sweden | |
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Goteborg, Sweden | |
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Grangesberg, Sweden | |
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Hollviken, Sweden | |
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Koping, Sweden | |
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Kristinehamn, Sweden | |
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Lulea, Sweden | |
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Marsta, Sweden | |
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Orebro, Sweden | |
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Stenstorp, Sweden | |
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Sunne, Sweden | |
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Uppsala, Sweden | |
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Vannas, Sweden | |
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Balsta, Sweden | |
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LINKOPING, Sweden | |
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NACKA, Sweden | |
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NYKOPING, Sweden | |
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Varekil, Sweden |
Study Director: | AstraZeneca Sweden Medical Director, MD | AstraZeneca |
Study ID Numbers: | D9612L00085, IMPROVE, EudraCT-number 2005-000458-57 |
Study First Received: | January 4, 2006 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00272701 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Proton Pump Inhibitors Esophageal Disorder |
Gastrointestinal Diseases Omeprazole Esophageal Diseases Gastroesophageal Reflux |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Omeprazole Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions |
Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Esophageal Diseases |