Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole Clinical Trial
— NEXBAC| Verified date | May 2008 |
| Source | Technische Universität München |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | May 2008 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Technical University of Munich | Munich | Bavaria |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität München |
Germany,