Clinical trial NCT00739635: Efficacy, Safety and Tolerability of Neramexane 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: 2008-08-22
Enrollment: 411
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 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:

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

Primary outcomes:
measure: TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap 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 responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
timeFrame: 17 weeks
measure: safety parameters
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Kufstein
country: Austria
facility: Bezirkskrankenhaus Kufstein
city: Linz
country: Austria
facility: A. ö. Krankenhaus der Elisabethinen Linz
city: Salzburg
country: Austria
facility: Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
city: Vienna
country: Austria
facility: Clin Pharm International GmbH, Zentrum Wien
city: Halle
country: Germany
facility: Dr. Elisabeth Kühne
state: Saale
city: Aachen
country: Germany
facility: Dr. med. Nobert Pasch
city: Augsburg
country: Germany
facility: Dr. Peter Küppers
city: Berlin
country: Germany
facility: Charité, Universitätsmedizin Berlin-Tinnituszentrum
city: Berlin
country: Germany
facility: Klin. Forschung Berlin Buch GmbH
city: Braunschweig
country: Germany
facility: Dr. med. Frank Reintjes
city: Chemnitz
country: Germany
facility: ClinPharm International
city: Darmstadt
country: Germany
facility: Dr. Klaus Peter Jayme
city: Dresden
country: Germany
facility: Dr. Christian Dörr
city: Duisburg
country: Germany
facility: HNO-Praxis im Gesundheitszentrum Walsum
city: Frankfurt
country: Germany
facility: ClinPharm International GmbH
city: Görlitz
country: Germany
facility: ClinPharm International GmbH
city: Heiligenhaus
country: Germany
facility: Dr. Werner Gieselmann
city: Iserlohn
country: Germany
facility: Dr. Wolfgang Lotte
city: Leipzig
country: Germany
facility: ClinPharm International GmbH
city: Lichtenfels
country: Germany
facility: HNO Praxis
city: Lorsch
country: Germany
facility: Dr. Dannesberger
city: Magdeburg
country: Germany
facility: ClinPharm International
city: Meppen
country: Germany
facility: HNO Gemeinschaftpraxis
city: Munich
country: Germany
facility: LMU München Klinik Großhadern
city: Nürnberg
country: Germany
facility: Dr. med. Ulrike Walter
city: Nürnberg
country: Germany
facility: Dr. Susanne Wiedemann
city: Schlüchtern
country: Germany
facility: Dr. Norbert Staab
city: Wiesbaden
country: Germany
facility: Dr. Hannelore Neumaier
city: Worms
country: Germany
facility: Dr. med. Stephanie Göbel
city: Porto
country: Portugal
facility: Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
city: Porto
country: Portugal
facility: Clínica ORL Dr. Eurico de Almeida
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra, Dept. ORL
state: Navarra
city: Sagunto
country: Spain
facility: Hospital Sagunto
state: Valencia
city: Alcorcón - Madrid
country: Spain
facility: Fundación Hospital de Alcorcón, Otorhinolaryngology
city: Barcelona
country: Spain
facility: Hospital Clínico Barcelona, Dept. Of ORL
city: Jaén
country: Spain
facility: Clinica Clivina, Private Consultancy
city: Linares, Jaén
country: Spain
facility: Hospital Comarcal San Agustin
city: Lugo
country: Spain
facility: Hospital Xeral-Calde
city: Madrid
country: Spain
facility: Hospital Puerta del Hierro, Madrid- Servicio de OR
city: Madrid
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Universtiario Son Dureta
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca- Hospital Virgen de la Vega
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
city: Bath
country: United Kingdom
facility: Oldfield Surgery
city: Chesterfield
country: United Kingdom
facility: Avondale Surgery Research office
city: East Horsley, Leatherhead, Surrey
country: United Kingdom
facility: The Horsley Medical Practice
city: Leicestershire
country: United Kingdom
facility: Burbage Surgery
city: Leicester
country: United Kingdom
facility: The university Hospitals of Leicester, Leicester Royal Infirmary
city: Newcastle upon Tyne
country: United Kingdom
facility: The Freeman Hospital
city: Petereborough
country: United Kingdom
facility: Wansford and Kings Cliffe Practice
city: Somerset
country: United Kingdom
facility: Frome Medical Practice
city: Warwick Shire
country: United Kingdom
facility: Dr. Trevor Gooding
city: Warwickshire
country: United Kingdom
facility: Sherbourne Medical Centre
Study officials:
References: