High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease - Full Text View

Sponsored by:	Technische Universität München
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00461604

Purpose

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.

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

MedlinePlus related topics: GERD

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Baclofen

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

Further study details as provided by Technische Universität München:

Estimated Enrollment:	40
Study Start Date:	October 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461604

Locations

Germany, Bavaria
Technical University of Munich
Munich, Bavaria, Germany, 81675

Sponsors and Collaborators

Technische Universität München

Investigators

Principal Investigator:

Alexander Meining, MD

Technische University Munich

More Information

Responsible Party:	Technische Universität München ( Technische Universität München, II. Medizinische Klinik )
Study ID Numbers:	1690/07
Study First Received:	April 16, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00461604
Health Authority:	Germany: Ethics Commission

Keywords provided by Technische Universität München:

gastroesophageal reflux disease
baclofen
impedance

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Baclofen
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 16, 2009