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

High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease (NEXBAC)

This study has been completed.

First Received on April 16, 2007. Last Updated on May 19, 2008 History of Changes

Sponsor:	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

Study Type:	Observational
Study Design:	Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Baclofen

U.S. FDA Resources

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
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

No publications provided

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

Keywords provided by Technische Universität München:

gastroesophageal reflux disease
baclofen
impedance

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012