Study Results
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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COMPLETED
PHASE4
450 participants
INTERVENTIONAL
2005-12-31
2007-02-28
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
NONE
Interventions
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Esomeprazole
Other PPI marketed in Sweden
Eligibility Criteria
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Inclusion Criteria
* Male or female, aged 18-65 years
* History of GERD symptoms during, at least, six months prior to enrolment
* PPI as maintenance treatment during the last 30 days prior to enrolment
* Heartburn as predominant GERD symptom, as judged by the investigator
* Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)
Exclusion Criteria
* Current or historical evidence of the following diseases/conditions, as judged by the investigator:Zollinger-Ellison syndrome,Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm,
* Gastric or duodenal ulcers within the last three months, Malabsorbtion
* Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study
* Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable
* Patients with severe diseases or disorders which may interfere with the conduct of the study
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Sweden Medical Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Arlöv, , Sweden
Research Site
Åkersberga, , Sweden
Research site
Bålsta, , Sweden
Research Site
Borås, , Sweden
Research Site
Bromma, , Sweden
Research Site
Bromölla, , Sweden
Research Site
Dalby, , Sweden
Research Site
Djursholm, , Sweden
Research Site
Enskededalen, , Sweden
Research Site
Gothenburg, , Sweden
Research Site
Grängesberg, , Sweden
Research Site
Härnösand, , Sweden
Research Site
Helsingborg, , Sweden
Research Site
Höllviken, , Sweden
Research Site
Jarfalla, , Sweden
Research Site
Kil, , Sweden
Research Site
Knäred, , Sweden
Research Site
Köping, , Sweden
Research Site
Kristinehamn, , Sweden
Research Site
Linköping, , Sweden
Research Site
Ludvika, , Sweden
Research Site
Luleå, , Sweden
Research Site
Lund, , Sweden
Research Site
Malmo, , Sweden
Research Site
Märsta, , Sweden
Research Site
Nacka, , Sweden
Research Site
Nyköping, , Sweden
Research Site
Örebro, , Sweden
Research Site
Partille, , Sweden
Research Site
Piteå, , Sweden
Research Site
Sandviken, , Sweden
Research Site
Solna, , Sweden
Research Site
Stenstorp, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Sunne, , Sweden
Research Site
Täby, , Sweden
Research Site
Trollhättan, , Sweden
Research Site
Uppsala, , Sweden
Research Site
Varberg, , Sweden
Research Site
Varekil, , Sweden
Research Site
Vännäs, , Sweden
Research Site
Västerås, , Sweden
Countries
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References
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Ekesbo R, Sjostedt S, Sorngard H. Effects of structured follow-up and of more effective acid inhibitory treatment in the management of GORD patients in a Swedish primary-care setting: a randomized, open-label study. Clin Drug Investig. 2011;31(3):181-9. doi: 10.2165/11586330-000000000-00000.
Other Identifiers
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IMPROVE
Identifier Type: -
Identifier Source: secondary_id
EudraCT-number 2005-000458-57
Identifier Type: -
Identifier Source: secondary_id
D9612L00085
Identifier Type: -
Identifier Source: org_study_id
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