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Sponsors and Collaborators: |
University of Zurich AstraZeneca |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00574925 |
The primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (GERD).
A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25.
The secondary objectives are
Secondary endpoints will be analyzed by the following parameters and their interactions:
NSAID/ASA intake (for histological results)
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Disease (GERD) |
Drug: Esomeprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients With Gastroesophageal Reflux Disease (GERD) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
For inclusion in the study the subject must fulfill all of the following criteria:
Table 2: Lead GERD criteria
For inclusion in the study, all of the following lead GERD criteria should hold:
Exclusion criteria:
Any of the following is regarded as a criterion for exclusion from the study:
Study ID Numbers: | ACH-QBE-0201 |
Study First Received: | December 13, 2007 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00574925 History of Changes |
Health Authority: | Switzerland: Swissmedic |
H. pylori |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases 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 |