Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus
NCT ID: NCT00827008
Last Updated: 2012-11-28
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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TERMINATED
PHASE3
821 participants
INTERVENTIONAL
2009-01-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1, verum
Neramexane mesylate
Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance
Interventions
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Neramexane mesylate
Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance
Eligibility Criteria
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Inclusion Criteria
* patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study
Exclusion Criteria
* Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Meniére´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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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals
Locations
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Paradigm Clinical Research
Tucson, Arizona, United States
Providence Clinical Research
Burbank, California, United States
Central California Clinical Research
Fresno, California, United States
UC Davis Health System Department of Otolaryngology
Sacramento, California, United States
Colorado Otolaryngology Associates
Colorado Springs, Colorado, United States
New West Physicians
Golden, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Deerpath Physicians Group
Gurnee, Illinois, United States
Knight Center for Integrated Health,
Peoria, Illinois, United States
University of Kansas Department of Otolaryngology Head & Neck Surgery
Kansas City, Kansas, United States
Heartland Research Associates, LLC.
Wichita, Kansas, United States
Heartland Research Associates, LLC.
Wichita, Kansas, United States
Commonwealth Ear, Nose & Throat
Louisville, Kentucky, United States
Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
Kalispell, Montana, United States
Immedicenter
Bloomfield, New Jersey, United States
David L. Bortniker, M.D, FACS
Somerville, New Jersey, United States
Erie County Medical Center, Department of Rehabilitation Medicine
Buffalo, New York, United States
Montefiore Medical Center Attn: Anxiety and Depression Center
The Bronx, New York, United States
Cary Medical Research
Cary, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Wilmington Medical Research
Wilmington, North Carolina, United States
Piedmont Medical Research
Winston-Salem, North Carolina, United States
Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery
Charleston, South Carolina, United States
Future Search Trials of Neurology
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
South Texas Research Alliance LLC
Laredo, Texas, United States
Research Across America
Plano, Texas, United States
Advanced Clinical Research
West Jordon, Utah, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Krankenhaus der Elisabethinen
Graz, , Austria
Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
Kufstein, , Austria
Clin Pharm International GmbH, Zentrum Wien
Vienna, , Austria
University Hospital Brussels
Brussels, , Belgium
Clinique Universitaire Saint-luc
Brussels, , Belgium
AZ Sint Lucas, ENT department
Ghent, , Belgium
University Hospital Leuven, ENT Department
Leuven, , Belgium
Consultório Dr. Marcelo Rates
Belo Horizonte/Mimaf Gerais, , Brazil
Osmar Clayton Person
Santo André/SP, , Brazil
Instituto Ganz Sanchez
São Paulo/SP, , Brazil
Clínica OTOSUL
Valenca/RJ, , Brazil
Medico
Chodov, Prague, Czechia
prof. MUDr. Ivo Šlapák
Brno, , Czechia
Teaching University Hospital, ORL klinika
Brno, , Czechia
ORL oddělení, Karlovarská krajská nemocncie a.s.
Karlovy Vary, , Czechia
Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje
Kladno, , Czechia
Pro-audio,s.r.o.-private ENT clinic
Mladá Boleslav, , Czechia
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
Prague, , Czechia
ORL oddělení , Karlovarská krajská nemocnice a. s.
Sokolov, , Czechia
Dr. Ebbo
Issy-les-Moulineaux, , France
Dr. Sarfati
La Seyne-sur-Mer, , France
Centre Hospitalier de Bretagne Sud Service ORL-B9
Lorient, , France
Dr. Bonfils
Paris, , France
Dr. Ohresser
Paris, , France
Hopital Nord
Saint-Etienne, , France
Dr. Fraysse
Toulouse, , France
Service ORL CHU Bretonneau
Tours, , France
Hopital Paul BROUSSE Polyclinique
Villejuif, , France
Dr. Kühne, Elisabeth
Halle, Saale, Germany
Dr. med. Norbert Pasch
Aachen, , Germany
Charité, Universitätsmedizin Berlin-Tinnituszentrum
Berlin, , Germany
Klin. Forschung Berlin Buch GmbH
Berlin, , Germany
Dr. med. Frank Reintjes
Braunschweig, , Germany
DM Helena Sigal
Chemnitz, , Germany
Dr. Klaus Peter Jayme
Darmstadt, , Germany
Dr. Christian Dörr
Dresden, , Germany
HNO-Praxis im Gesundheitszentrum
Duisburg, , Germany
Dr. Gieselmann, Werner
Heiligenhaus, , Germany
Dr. Wolfgang Lotte
Iserlohn, , Germany
Dr. Dr. med. Hans-Detlev Stahl
Leipzig, , Germany
HNO Praxis
Lichtenfels, , Germany
Dr. Dannesberger
Lorsch, , Germany
ClinPharm International
Magdeburg, , Germany
HNO Gemeinschaftpraxis
Meppen, , Germany
Martin Canis, MD
Munich, , Germany
Dr. med. Ulrike Walter
Nuremberg, , Germany
Dr. Susanne Wiedemann
Nuremberg, , Germany
Dr. Norbert Staab
Schlüchtern, , Germany
Dr. Hannelore Neumaier
Wiesbaden, , Germany
Unidad Médica de Especialidades del Noroeste (UMEN)
Centro Culiacán Sinaloa, , Mexico
Hospital General de Chihuahua. "Dr. Salvador Anchondo"
Chihuahua C.P. 31000, , Mexico
Hospital Christus Muguerza del Parque
Chihuahua CP 3100, , Mexico
Internal Medicine Clin Trials (IMED)
Col Obispado, Monterrey , N.L. C.P. 64060, , Mexico
Hospital Civil de Guadalajara
Col. El Retiro CP 44280 Cuadalajara Jalis, , Mexico
Grupo Médico Terranova
CP 44630 Guadalajara Jalisco, , Mexico
Clinical Research Instutute S.C.
Edo. de México CP 54055, , Mexico
Instituto Biomédico de Investigación A.C.
Fracc. Bosques Del Prado Norte Aguascalientes, , Mexico
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
Jalisco, , Mexico
Monterrey International Research Center (MIRC)
Nuevo León CP 64000, , Mexico
Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología
Nuevo León CP 64400, , Mexico
Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología
San Luis Potosí, SLP, México, 78240, , Mexico
Andromed Zoetermeer
Zoetermeer, EK, Netherlands
Andromed Oost
Velp, ES, Netherlands
Rijnland Ziekenhuis, ENT department
Leiderdorp, GA, Netherlands
Andromed Rotterdam
Rotterdam, HC, Netherlands
Adromed Nijmegen
Nijmegen, HL, Netherlands
Andromed Leiden
Leiderdorp, RA, Netherlands
Andromed Breda
Breda, VL, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
Gdansk, , Poland
Szpital Miejski im. J.Brudzinskiego
Gdynia, , Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, , Poland
NZOZ Specjalistyczne Centrum Medyczne Nowomed
Krakow, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
Krakow, , Poland
Specjalistyczny Gabinet Otolaryngologiczny
Krakow, , Poland
Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Lublin, , Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, , Poland
Instytut Fizjologii i Patologii Sluchu
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, , Poland
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
Porto, , Portugal
Louis Leipoldt Mediclinic
Bellville, , South Africa
Lakeview Hospital
Benoni, , South Africa
1007 Louis Pasteur Building
Pretoria, , South Africa
GCT Eastmed Clinical Trial centre
Pretoria, , South Africa
Constantiaberg Medi Clinic,
Western Cape, , South Africa
Prince Alfred House
Wynberg, , South Africa
Hospital Sagunto
Sagunto, Valencia, Spain
Fundación Hospital de Alcorcón, Otorhinolaryngology
Alcorcon - Madrid, , Spain
Hospital Clínico Barcelona, Dept. Of ORL
Barcelona, , Spain
Hospital Puerta del Hierro, Madrid- Servicio de ORL
Madrid, , Spain
Hospital Universitario Príncipe de Asturias
Madrid, , Spain
Clínica Universitaria de Navarra, Dept. ORL
Pamplona, Navarra, , Spain
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
Salamanca, , Spain
Oldfield Surgery
Bath, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Avondale Surgery, Research Office
Chesterfield, , 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
Sherbourne Medical Centre
Warwickshire, , United Kingdom
Countries
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Other Identifiers
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2008-001432-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRZ 92579/TI/3004
Identifier Type: -
Identifier Source: org_study_id