NCT00461604

High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-04-18
• Last updated: 2008-05-20

Locations

1 site across 1 country: Germany