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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461604
First Posted: April 18, 2007
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Technische Universität München, II. Medizinische Klinik, Technische Universität München
ClinicalTrials.gov Identifier: NCT00461604     History of Changes
Other Study ID Numbers: 1690/07
First Submitted: April 16, 2007
First Posted: April 18, 2007
Last Update Posted: May 20, 2008
Last Verified: May 2008

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