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Clinical Trials/NCT00461604
NCT00461604
Completed
Not Applicable

High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

Technical University of Munich1 site in 1 country40 target enrollmentOctober 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole
Sponsor
Technical University of Munich
Enrollment
40
Locations
1
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
May 2008
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Technical University of Munich

Eligibility Criteria

Inclusion Criteria

  • age between 18-70 years
  • informed consent
  • patients with persistent reflux-associated symptoms despite PPI-therapy

Exclusion Criteria

  • synthetic liver diseases
  • renal failure
  • disability to understand informed consent

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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