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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number 2008-000639-16 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day |
|
| 2 | Placebo Comparator | Drug: Placebo Double-blind treatment period of 17 weeks placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neramexane mesylate | Drug | Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment | Screening, Baseline, week 5, 13, 17 |
| Measure | Description | Time Frame |
|---|---|---|
| TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics | 29 weeks | |
| safety parameters | 29 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint Lucas, ENT department | Assebroek-Brugge | 8310 | Belgium | |||
| University Hospital Brussels, ENT department |
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| Placebo | Drug | Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up. |
|
| Brussels |
| 1090 |
| Belgium |
| Clinique Universitaire Saint-Luc | Brussels | 1200 | Belgium |
| Dr. Henri HABERMAN | Brussels | 1200 | Belgium |
| AZ Sint Lucas, ENT department | Ghent | 9000 | Belgium |
| Centre hospitalier de jolimont | La Louvière | 7100 | Belgium |
| University Hospital Leuven, ENT Department | Leuven | 3000 | Belgium |
| CHU Liege Service ORL | Liège | 4000 | Belgium |
| Medico | Chodov | Prague | Czechia |
| Prof. MUDr. Ivo Šlapák, CSc | Brno | 60200 | Czechia |
| Teaching University Hospital, ORL klinika | Brno | 65691 | Czechia |
| Nemocnice Havlíčkův Brod | Havlíčkův Brod | 58022 | Czechia |
| ORL - Otorynolaryngologické oddělení | Jihlava | 58633 | Czechia |
| ORL oddělení, Karlovarská krajská nemocncie a.s. | Karlovy Vary | 36066 | Czechia |
| Oblastní nemocnice Kladno a.s. | Kladno | 27259 | Czechia |
| Pro-audio,s.r.o.-private ENT clinic | Mladá Boleslav | 29301 | Czechia |
| ORL oddělení, Všeobecná Fakultní Nemocnice v Praze | Prague | 12808 | Czechia |
| ORL oddělení , Karlovarská krajská nemocnice a. s. | Sokolov | 35601 | Czechia |
| Dr. Ebbo | Issy-les-Moulineaux | 92130 | France |
| Dr. Sarfati | La Seyne-sur-Mer | 83500 | France |
| Centre Hospitalier de Bretagne Sud Service | Lorient | 56322 | France |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| BONFILS | Paris | 75015 | France |
| OHRESSER | Paris | 75015 | France |
| Hopital Nord | Saint-Etienne | 42055 | France |
| FRAYSSE | Toulouse | 31059 | France |
| Service ORL CHU | Tours | 37044 | France |
| Hopital Paul BROUSSE Polyclinique | Villejuif | 94800 | France |
| Andromed Breda | Breda | 4811 VL | Netherlands |
| Andromed Leiden | Leiderdorp | 2352 RA | Netherlands |
| Rijnland Ziekenhuis, ENT department | Leiderdorp | 2353 GA | Netherlands |
| Adromed Nijmegen | Nijmegen | 6533 HL | Netherlands |
| Andromed Rotterdam | Rotterdam | 3021 HC | Netherlands |
| Andromed Rotterdam | Rotterdam | HC 3021 | Netherlands |
| Andromed Oost | Velp | 6883 ES | Netherlands |
| Andromed Zoetermeer | Zoetermeer | 2724 EK | Netherlands |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | 15-279 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS | Gdansk | 80-288 | Poland |
| Szpital Miejski im. J.Brudzinskiego | Gdynia | 81-348 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | 40-027 | Poland |
| NZOZ Specjalistyczne Centrum Medyczne Nowomed | Krakow | 30-349 | Poland |
| Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz | Krakow | 31-534 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej PROMED | Krakow | 31-636 | Poland |
| Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii | Krakow | 31-913 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | 91-153 | Poland |
| Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi | Lodz | 91-348 | Poland |
| Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Lublin | 20-718 | Poland |
| Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | 10-561 | Poland |
| Instytut Fizjologii i Patologii Sluchu | Warsaw | 01-943 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu | Wroclaw | 50-369 | Poland |
| Louis Leipoldt Mediclinic | Bellville | 7530 | South Africa |
| Lakeview Hospital | Benoni | 1501 | South Africa |
| Dr. A. Viljoen | Pretoria | 0002 | South Africa |
| GCT Eastmed Clinical Trial centre | Pretoria | 0186 | South Africa |
| Constantiaberg Medi Clinic | Western Cape | 7800 | South Africa |
| Dr. J. Steer | Wynberg | 7800 | South Africa |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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