Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
NCT ID: NCT00739635
Last Updated: 2016-02-04
Study Results
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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COMPLETED
PHASE3
411 participants
INTERVENTIONAL
2008-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
2
Placebo
Double-blind treatment period of 17 weeks placebo
Interventions
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Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Placebo
Double-blind treatment period of 17 weeks placebo
Eligibility Criteria
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Inclusion Criteria
* Persistent (i.e. tinnitus should never be absent for \> 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months
Exclusion Criteria
* Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)
18 Years
75 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Locations
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Krankenhaus der Elisabethinen
Graz, , Austria
Bezirkskrankenhaus Kufstein
Kufstein, , Austria
A. ö. Krankenhaus der Elisabethinen Linz
Linz, , Austria
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, , Austria
Clin Pharm International GmbH, Zentrum Wien
Vienna, , Austria
Dr. Elisabeth Kühne
Halle, Saale, Germany
Dr. med. Nobert Pasch
Aachen, , Germany
Dr. Peter Küppers
Augsburg, , Germany
Charité, Universitätsmedizin Berlin-Tinnituszentrum
Berlin, , Germany
Klin. Forschung Berlin Buch GmbH
Berlin, , Germany
Dr. med. Frank Reintjes
Braunschweig, , Germany
ClinPharm International
Chemnitz, , Germany
Dr. Klaus Peter Jayme
Darmstadt, , Germany
Dr. Christian Dörr
Dresden, , Germany
HNO-Praxis im Gesundheitszentrum Walsum
Duisburg, , Germany
ClinPharm International GmbH
Frankfurt, , Germany
ClinPharm International GmbH
Görlitz, , Germany
Dr. Werner Gieselmann
Heiligenhaus, , Germany
Dr. Wolfgang Lotte
Iserlohn, , Germany
ClinPharm International GmbH
Leipzig, , Germany
HNO Praxis
Lichtenfels, , Germany
Dr. Dannesberger
Lorsch, , Germany
ClinPharm International
Magdeburg, , Germany
HNO Gemeinschaftpraxis
Meppen, , Germany
LMU München Klinik Großhadern
Munich, , Germany
Dr. med. Ulrike Walter
Nuremberg, , Germany
Dr. Susanne Wiedemann
Nuremberg, , Germany
Dr. Norbert Staab
Schlüchtern, , Germany
Dr. Hannelore Neumaier
Wiesbaden, , Germany
Dr. med. Stephanie Göbel
Worms, , Germany
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
Porto, , Portugal
Clínica ORL Dr. Eurico de Almeida
Porto, , Portugal
Clínica Universitaria de Navarra, Dept. ORL
Pamplona, Navarre, Spain
Hospital Sagunto
Sagunto, Valencia, Spain
Fundación Hospital de Alcorcón, Otorhinolaryngology
Alcorcón - Madrid, , Spain
Hospital Clínico Barcelona, Dept. Of ORL
Barcelona, , Spain
Clinica Clivina, Private Consultancy
Jaén, , Spain
Hospital Comarcal San Agustin
Linares, Jaén, , Spain
Hospital Xeral-Calde
Lugo, , Spain
Hospital Puerta del Hierro, Madrid- Servicio de OR
Madrid, , Spain
Hospital Universitario Príncipe de Asturias
Madrid, , Spain
Hospital Universtiario Son Dureta
Palma de Mallorca, , Spain
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
Salamanca, , Spain
Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
Seville, , Spain
Oldfield Surgery
Bath, , United Kingdom
Avondale Surgery Research office
Chesterfield, , United Kingdom
The Horsley Medical Practice
East Horsley, Leatherhead, Surrey, , United Kingdom
The university Hospitals of Leicester, Leicester Royal Infirmary
Leicester, , United Kingdom
Burbage Surgery
Leicestershire, , United Kingdom
The Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Wansford and Kings Cliffe Practice
Petereborough, , United Kingdom
Frome Medical Practice
Somerset, , United Kingdom
Dr. Trevor Gooding
Warwick Shire, , United Kingdom
Sherbourne Medical Centre
Warwickshire, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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EudraCT Number 2007-007835-16
Identifier Type: -
Identifier Source: secondary_id
MRZ 92579/TI/3001
Identifier Type: -
Identifier Source: org_study_id
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