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

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ClinicalTrials.gov Identifier: NCT00461604
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : May 20, 2008
Information provided by:
Technische Universität München

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.

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

Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Prospective
Study Start Date : October 2006
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

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

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

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

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

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 Posted: April 18, 2007    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 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