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

This study has been completed.
Information provided by:
Technische Universität München Identifier:
First received: April 16, 2007
Last updated: May 19, 2008
Last verified: May 2008

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.

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:

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)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00461604

Technical University of Munich
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Principal Investigator: Alexander Meining, MD Technische University Munich
  More Information

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

Keywords provided by Technische Universität München:
gastroesophageal reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on May 25, 2017