High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease
Information source: Technische Universität München
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole
Phase: N/A
Status: Completed
Sponsored by: Technische Universität München Official(s) and/or principal investigator(s):
Alexander Meining, MD, Principal Investigator, Affiliation: Technische University Munich
Summary
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.
Clinical Details
Study design: Prospective
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age between 18-70 years
- informed consent
- patients with persistent reflux-associated symptoms despite PPI-therapy
Exclusion Criteria:
- epilepsy
- synthetic liver diseases
- renal failure
- disability to understand informed consent
Locations and Contacts
Technical University of Munich, Munich, Bavaria 81675, Germany
Additional Information
Starting date: October 2006
Ending date: May 2008
Last updated: May 19, 2008
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