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High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00461604
Acronym
NEXBAC
Enrollment
40
Registered
2007-04-18
Start date
2006-10-31
Completion date
2008-05-31
Last updated
2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole

Keywords

gastroesophageal reflux disease, baclofen, impedance

Brief 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.

Interventions

None listed

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026