Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
NCT ID: NCT00955799
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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COMPLETED
PHASE3
455 participants
INTERVENTIONAL
2009-09-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neramexane mesylate
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Neramexane mesylate
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Placebo
Placebo: identical placebo tablets
Placebo
Double-blind treatment period of 29 weeks placebo
Interventions
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Neramexane mesylate
Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day
Placebo
Double-blind treatment period of 29 weeks placebo
Eligibility Criteria
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Inclusion Criteria
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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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals
Locations
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Horizon Clinical Research Associates PLLC
Gilbert, Arizona, United States
Phoenix Clinical
Phoenix, Arizona, United States
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
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
Tampa Bay Medical Research
Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Deerpath Physicians Group
Gurnee, Illinois, United States
Knight Center for Integrated Health
Peoria, Illinois, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Deaconess Clinic, Inc.
Newburgh, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 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
Somerville, New Jersey, United States
Erie County Medical Center, Department of Rehabilitation Medicine; State University of New York at Buffalo
Buffalo, New York, United States
Montefiore Medical 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 Carlolina, Otolaryngology
Charleston, South Carolina, United States
Austin Ear, Nose and Throat Clinic
Austin, Texas, 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
Kufstein, , Austria
A. ö. Krankenhaus der Elisabethinen Linz
Linz, , Austria
Clin Pharm International GmbH, Zentrum Wien
Vienna, , Austria
Consultório Dr. Marcelo Rates
Belo Horizonte, , Brazil
Instituto de Otorrinolaringologia Linhares
Rio de Janeiro, , Brazil
Hospital de Clinicas de Porto Alegre
Rio Grande, , Brazil
Faculdade de Medicina do ABC
Santo André/SP, , Brazil
Universidade Federal de São Paulo - UNIFESP
Sao Paulo/ SP, , Brazil
Instituto Ganz Sanchez
São Paulo/SP, , Brazil
Clínica OTOSUL
Valença, , Brazil
Klin. Forschung Berlin Buch GmbH
Berlin, , Germany
Praxis im Schlosscarree
Braunschweig, , Germany
Dr. Klaus Peter Jayme
Darmstadt, , Germany
Dr. Christian Dörr
Dresden, , Germany
Dr. Elisabeth Kühne
Halle, , Germany
Dr. Werner Gieselmann
Heiligenhaus, , Germany
Dr. Wolfgang Lotte
Iserlohn, , Germany
ClinPharm International GmbH
Leipzig, , Germany
HNO Praxis, Bamberger Str. 7
Lichtenfels, , Germany
Dr. Dannesberger
Lorsch, , Germany
LMU München, Klinikum Großhadern
München, , Germany
Dr. Susanne Wiedemann
Nuremberg, , Germany
Instituto Biomédico de Investigación A.C.
Aguascalientes, , Mexico
Hospital General de Chihuahua
Chihuahua City, , Mexico
Hospital Christus Muguerza del Parque
Chihuahua City, , Mexico
Clinical Research Instutute S.C.
Edo. de México, , Mexico
Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Otorrinolaringología; Hospital No. 278
Guadalajara Jalisco, , Mexico
Grupo Médico Terranova
Guadalajara Jalisco, , Mexico
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
Jalisco, , Mexico
Hospital General de México S.S. O.D.; Servicio de Otorrinolaringología
México D.F., , Mexico
Hospital OCA Monterrey International Research Center (MIRC)
Nuevo León, , Mexico
Hospital Universitario
Nuevo León, , Mexico
Unidad de Tratamientos Avanzados (UTRAV) S.C.
Nuevo León, , Mexico
Hospital Central "Dr. Ignacio Morones Prieto"; Servicio de Otorrinolaringología
San Luis Potosí City, , Mexico
Medicentro del Parque
San Luis Potosí City, , Mexico
Unidad Médica de Especialidades del Noroeste (UMEN)
Sinaloa, , Mexico
Countries
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Other Identifiers
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2009-011246-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRZ 92579/TI/3003
Identifier Type: -
Identifier Source: org_study_id