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Sponsored by: |
Technische Universität München |
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Information provided by: | Technische Universität München |
ClinicalTrials.gov Identifier: | NCT00461604 |
It has been reported that Baclofen is an appropriate tool in the therapeutic management of Gastroesophageal Reflux Disease. To objectify gastroesophageal reflux combined pH-metry/impedance monitoring was applied to patients with persistent reflux-associated symptoms despite PPI-therapy (40mg esomeprazole for 2 weeks). After provement of pathological findings in the test PPI-dosage was escalated to double standard-dosage for another for weeks. In case of persistent symptoms another ph-metry/impedance monitoring was performed. In case of pathological findings additional baclofen was administered to the therapeutic regime. After 3 months another ph-metry/impedance monitoring was performed. At the time point of the tests a questionnaire was completed.
Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional baclofen in patients with persistent symptoms and objectified gastroesophageal reflux.
Condition |
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Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy
With 40mg Esomeprazole |
Study Type: | Observational |
Study Design: | Prospective |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Bavaria | |
Technical University of Munich | |
Munich, Bavaria, Germany, 81675 |
Principal Investigator: | Alexander Meining, MD | Technische University Munich |
Responsible Party: | Technische Universität München ( Technische Universität München, II. Medizinische Klinik ) |
Study ID Numbers: | 1690/07 |
Study First Received: | April 16, 2007 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00461604 History of Changes |
Health Authority: | Germany: Ethics Commission |
gastroesophageal reflux disease baclofen impedance |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal Disorder Gastrointestinal Diseases |
Baclofen Omeprazole Esophageal Diseases Gastroesophageal Reflux |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux |