High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

NCT ID: NCT00461604

Last Updated: 2008-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-05-31

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.

Conditions

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

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Technische Universität München

Principal Investigators

Alexander Meining, MD

Role: PRINCIPAL_INVESTIGATOR

Technische University Munich

Locations

Technical University of Munich

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

1690/07

Identifier Type: -

Identifier Source: org_study_id