High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease (NEXBAC)
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|ClinicalTrials.gov Identifier: NCT00461604|
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : May 20, 2008
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 or disease|
|Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461604
|Technical University of Munich|
|Munich, Bavaria, Germany, 81675|
|Principal Investigator:||Alexander Meining, MD||Technische University Munich|