Clinical trial NCT00772980: Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus
Official title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Subjective Tinnitus
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.


Eligibility criteria: Inclusion Criteria:

* patients aged 18 to 75 years with a clinical diagnosis of first onset, persistent (i.e. tinnitus sghould never be absent for \>24 hours in a row), subjective, uni-or bilateral tinntius present for at least 3 months but not more than 12 months.

Exclusion Criteria:

* Clinical diagnosis of intermittent or pulsatile tinnitus
* Patients who have tinnitus as a concomitant symptom of an otological/neurological disease(such as otitis media, Meniére´s disease, otosclerosis, etc.)

Primary outcomes:
measure: TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment
timeFrame: Screening, Baseline, week 5, 13, 17
Secondary outcomes:
measure: TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
timeFrame: 29 weeks
measure: safety parameters
timeFrame: 29 weeks
Other outcomes:
Locations:
city: Assebroek-Brugge
country: Belgium
facility: AZ Sint Lucas, ENT department
city: Brussels
country: Belgium
facility: University Hospital Brussels, ENT department
city: Brussels
country: Belgium
facility: Clinique Universitaire Saint-Luc
city: Bruxelles
country: Belgium
facility: Dr. Henri HABERMAN
city: Gent
country: Belgium
facility: AZ Sint Lucas, ENT department
city: La Louvière
country: Belgium
facility: Centre hospitalier de jolimont
city: Leuven
country: Belgium
facility: University Hospital Leuven, ENT Department
city: Liège
country: Belgium
facility: CHU Liege Service ORL
city: Chodov
country: Czech Republic
facility: Medico
state: Prague
city: Brno
country: Czech Republic
facility: Prof. MUDr. Ivo Šlapák, CSc
city: Brno
country: Czech Republic
facility: Teaching University Hospital, ORL klinika
city: Havlíčkův Brod
country: Czech Republic
facility: Nemocnice Havlíčkův Brod
city: Jihlava
country: Czech Republic
facility: ORL - Otorynolaryngologické oddělení
city: Karlovy Vary
country: Czech Republic
facility: ORL oddělení, Karlovarská krajská nemocncie a.s.
city: Kladno
country: Czech Republic
facility: Oblastní nemocnice Kladno a.s.
city: Mladá Boleslav
country: Czech Republic
facility: Pro-audio,s.r.o.-private ENT clinic
city: Praha
country: Czech Republic
facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
city: Sokolov
country: Czech Republic
facility: ORL oddělení , Karlovarská krajská nemocnice a. s.
city: Issy les moulineaux
country: France
facility: Dr. Ebbo
city: La seyne sur Mer
country: France
facility: Dr. Sarfati
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud Service
city: Lyon cedex 03
country: France
facility: Hopital Edouard Herriot
city: Paris
country: France
facility: BONFILS
city: Paris
country: France
facility: OHRESSER
city: Saint-Etienne
country: France
facility: Hopital Nord
city: Toulouse cedex
country: France
facility: FRAYSSE
city: Tours
country: France
facility: Service ORL CHU
city: Villejuif
country: France
facility: Hopital Paul BROUSSE Polyclinique
city: Breda
country: Netherlands
facility: Andromed Breda
city: Leiderdorp
country: Netherlands
facility: Andromed Leiden
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis, ENT department
city: Nijmegen
country: Netherlands
facility: Adromed Nijmegen
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Velp
country: Netherlands
facility: Andromed Oost
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Gdansk
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
city: Gdynia
country: Poland
facility: Szpital Miejski im. J.Brudzinskiego
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
city: Krakow
country: Poland
facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
city: Krakow
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
city: Lodz
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Lodz
country: Poland
facility: Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Warszawa
country: Poland
facility: Instytut Fizjologii i Patologii Sluchu
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
city: Bellville
country: South Africa
facility: Louis Leipoldt Mediclinic
city: Benoni
country: South Africa
facility: Lakeview Hospital
city: Pretoria
country: South Africa
facility: Dr. A. Viljoen
city: Pretoria
country: South Africa
facility: GCT Eastmed Clinical Trial centre
city: Western Cape
country: South Africa
facility: Constantiaberg Medi Clinic
city: Wynberg
country: South Africa
facility: Dr. J. Steer
Study officials:
References: