Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus
NCT ID: NCT00772980
Last Updated: 2010-07-01
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
400 participants
INTERVENTIONAL
2008-11-30
2010-06-30
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
TRIPLE
Study Groups
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1
Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
2
Drug: Placebo Double-blind treatment period of 17 weeks placebo
Placebo
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
Interventions
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Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
Placebo
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
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, 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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Merz Pharmaceuticals GmbH
Locations
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AZ Sint Lucas, ENT department
Assebroek-Brugge, , Belgium
University Hospital Brussels, ENT department
Brussels, , Belgium
Clinique Universitaire Saint-Luc
Brussels, , Belgium
Dr. Henri HABERMAN
Brussels, , Belgium
AZ Sint Lucas, ENT department
Ghent, , Belgium
Centre hospitalier de jolimont
La Louvière, , Belgium
University Hospital Leuven, ENT Department
Leuven, , Belgium
CHU Liege Service ORL
Liège, , Belgium
Medico
Chodov, Prague, Czechia
Prof. MUDr. Ivo Šlapák, CSc
Brno, , Czechia
Teaching University Hospital, ORL klinika
Brno, , Czechia
Nemocnice Havlíčkův Brod
Havlíčkův Brod, , Czechia
ORL - Otorynolaryngologické oddělení
Jihlava, , Czechia
ORL oddělení, Karlovarská krajská nemocncie a.s.
Karlovy Vary, , Czechia
Oblastní nemocnice Kladno a.s.
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
Lorient, , France
Hopital Edouard Herriot
Lyon, , France
BONFILS
Paris, , France
OHRESSER
Paris, , France
Hopital Nord
Saint-Etienne, , France
FRAYSSE
Toulouse, , France
Service ORL CHU
Tours, , France
Hopital Paul BROUSSE Polyclinique
Villejuif, , France
Andromed Breda
Breda, , Netherlands
Andromed Leiden
Leiderdorp, , Netherlands
Rijnland Ziekenhuis, ENT department
Leiderdorp, , Netherlands
Adromed Nijmegen
Nijmegen, , Netherlands
Andromed Rotterdam
Rotterdam, , Netherlands
Andromed Rotterdam
Rotterdam, , Netherlands
Andromed Oost
Velp, , Netherlands
Andromed Zoetermeer
Zoetermeer, , 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
Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
Krakow, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
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
Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera 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
Louis Leipoldt Mediclinic
Bellville, , South Africa
Lakeview Hospital
Benoni, , South Africa
Dr. A. Viljoen
Pretoria, , South Africa
GCT Eastmed Clinical Trial centre
Pretoria, , South Africa
Constantiaberg Medi Clinic
Western Cape, , South Africa
Dr. J. Steer
Wynberg, , South Africa
Countries
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Other Identifiers
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EudraCT Number 2008-000639-16
Identifier Type: -
Identifier Source: secondary_id
MRZ 92579/TI/3002
Identifier Type: -
Identifier Source: org_study_id
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