Full Text View
Tabular View
No Study Results Posted
Related Studies
High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease (NEXBAC)
This study has been completed.
First Received: April 16, 2007   Last Updated: May 19, 2008   History of Changes
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

Study Type: Observational
Study Design: 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

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

No publications provided

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     History of Changes
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

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on September 04, 2009