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Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00772980
First received: October 13, 2008
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Subjective Tinnitus
Drug: Neramexane mesylate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment [ Time Frame: Screening, Baseline, week 5, 13, 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 29 weeks ] [ Designated as safety issue: No ]
  • safety parameters [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
Placebo Comparator: 2
Drug: Placebo Double-blind treatment period of 17 weeks placebo
Drug: Placebo
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772980

  Hide Study Locations
Locations
Belgium
AZ Sint Lucas, ENT department
Assebroek-Brugge, Belgium, 8310
Clinique Universitaire Saint-Luc
Brussels, Belgium, 1200
University Hospital Brussels, ENT department
Brussels, Belgium, 1090
Dr. Henri HABERMAN
Bruxelles, Belgium, 1200
AZ Sint Lucas, ENT department
Gent, Belgium, 9000
Centre hospitalier de jolimont
La Louvière, Belgium, 7100
University Hospital Leuven, ENT Department
Leuven, Belgium, 3000
CHU Liege Service ORL
Liège, Belgium, 4000
Czech Republic
Medico
Chodov, Prague, Czech Republic
Prof. MUDr. Ivo Šlapák, CSc
Brno, Czech Republic, 60200
Teaching University Hospital, ORL klinika
Brno, Czech Republic, 65691
Nemocnice Havlíčkův Brod
Havlíčkův Brod, Czech Republic, 58022
ORL - Otorynolaryngologické oddělení
Jihlava, Czech Republic, 58633
ORL oddělení, Karlovarská krajská nemocncie a.s.
Karlovy Vary, Czech Republic, 36066
Oblastní nemocnice Kladno a.s.
Kladno, Czech Republic, 27259
Pro-audio,s.r.o.-private ENT clinic
Mladá Boleslav, Czech Republic, 29301
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
Praha, Czech Republic, 12808
ORL oddělení , Karlovarská krajská nemocnice a. s.
Sokolov, Czech Republic, 35601
France
Dr. Ebbo
Issy les moulineaux, France, 92130
Dr. Sarfati
La seyne sur Mer, France, 83500
Centre Hospitalier de Bretagne Sud Service
Lorient, France, 56322
Hopital Edouard Herriot
Lyon cedex 03, France, 69437
BONFILS
Paris, France, 75015
OHRESSER
Paris, France, 75015
Hopital Nord
Saint-Etienne, France, 42055
FRAYSSE
Toulouse cedex, France, 31059
Service ORL CHU
Tours, France, 37044
Hopital Paul BROUSSE Polyclinique
Villejuif, France, 94800
Netherlands
Andromed Breda
Breda, Netherlands, 4811 VL
Rijnland Ziekenhuis, ENT department
Leiderdorp, Netherlands, 2353 GA
Andromed Leiden
Leiderdorp, Netherlands, 2352 RA
Adromed Nijmegen
Nijmegen, Netherlands, 6533 HL
Andromed Rotterdam
Rotterdam, Netherlands, 3021 HC
Andromed Rotterdam
Rotterdam, Netherlands, HC 3021
Andromed Oost
Velp, Netherlands, 6883 ES
Andromed Zoetermeer
Zoetermeer, Netherlands, 2724 EK
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15-279
Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
Gdansk, Poland, 80-288
Szpital Miejski im. J.Brudzinskiego
Gdynia, Poland, 81-348
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland, 40-027
Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
Krakow, Poland, 31-534
Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
Krakow, Poland, 31-913
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
Krakow, Poland, 31-636
NZOZ Specjalistyczne Centrum Medyczne Nowomed
Krakow, Poland, 30-349
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 91-153
Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi
Lodz, Poland, 91-348
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Lublin, Poland, 20-718
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland, 10-561
Instytut Fizjologii i Patologii Sluchu
Warszawa, Poland, 01-943
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, Poland, 50-369
South Africa
Louis Leipoldt Mediclinic
Bellville, South Africa, 7530
Lakeview Hospital
Benoni, South Africa, 1501
GCT Eastmed Clinical Trial centre
Pretoria, South Africa, 0186
Dr. A. Viljoen
Pretoria, South Africa, 0002
Constantiaberg Medi Clinic
Western Cape, South Africa, 7800
Dr. J. Steer
Wynberg, South Africa, 7800
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
  More Information

No publications provided

Responsible Party: Dr. Irena Pulte, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00772980     History of Changes
Other Study ID Numbers: MRZ 92579/TI/3002, EudraCT Number 2008-000639-16
Study First Received: October 13, 2008
Last Updated: June 30, 2010
Health Authority: South Africa: The Registrar of Medicines, Department of Health, Medicines Control Council
Belgium: DGM - Research & Development, Eurostation, blok 2
Czech Republic: Státní Ústav pro Kontrolu Léčiv (SÚKL)
France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), DEMEB - Unité, ssais Cliniques
Netherlands: De Centrale Commissie Mensgebonden Onderzoek
Poland: Centralna Ewidencja Badań Klinicznych (CEBK)

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014