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High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

NCT ID: NCT00461604

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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gastroesophageal reflux disease baclofen impedance

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Technische Universität München

Principal Investigators

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Alexander Meining, MD

Role: PRINCIPAL_INVESTIGATOR

Technische University Munich

Locations

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Technical University of Munich

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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1690/07

Identifier Type: -

Identifier Source: org_study_id