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

Primary Purpose

Subjective Tinnitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Neramexane mesylate
Placebo
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Tinnitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • AZ Sint Lucas, ENT department
  • University Hospital Brussels, ENT department
  • Clinique Universitaire Saint-Luc
  • Dr. Henri HABERMAN
  • AZ Sint Lucas, ENT department
  • Centre hospitalier de jolimont
  • University Hospital Leuven, ENT Department
  • CHU Liege Service ORL
  • Medico
  • Prof. MUDr. Ivo Šlapák, CSc
  • Teaching University Hospital, ORL klinika
  • Nemocnice Havlíčkův Brod
  • ORL - Otorynolaryngologické oddělení
  • ORL oddělení, Karlovarská krajská nemocncie a.s.
  • Oblastní nemocnice Kladno a.s.
  • Pro-audio,s.r.o.-private ENT clinic
  • ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
  • ORL oddělení , Karlovarská krajská nemocnice a. s.
  • Dr. Ebbo
  • Dr. Sarfati
  • Centre Hospitalier de Bretagne Sud Service
  • Hopital Edouard Herriot
  • BONFILS
  • OHRESSER
  • Hopital Nord
  • FRAYSSE
  • Service ORL CHU
  • Hopital Paul BROUSSE Polyclinique
  • Andromed Breda
  • Andromed Leiden
  • Rijnland Ziekenhuis, ENT department
  • Adromed Nijmegen
  • Andromed Rotterdam
  • Andromed Rotterdam
  • Andromed Oost
  • Andromed Zoetermeer
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
  • Szpital Miejski im. J.Brudzinskiego
  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
  • NZOZ Specjalistyczne Centrum Medyczne Nowomed
  • Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
  • Niepubliczny Zaklad Opieki Zdrowotnej PROMED
  • Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi
  • Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Instytut Fizjologii i Patologii Sluchu
  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
  • Louis Leipoldt Mediclinic
  • Lakeview Hospital
  • Dr. A. Viljoen
  • GCT Eastmed Clinical Trial centre
  • Constantiaberg Medi Clinic
  • Dr. J. Steer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day

Drug: Placebo Double-blind treatment period of 17 weeks placebo

Outcomes

Primary Outcome Measures

TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handycap Inventory-12") total score change from baseline to end of treatment

Secondary Outcome Measures

TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
safety parameters

Full Information

First Posted
October 13, 2008
Last Updated
June 30, 2010
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00772980
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo Double-blind treatment period of 17 weeks placebo
Intervention Type
Drug
Intervention Name(s)
Neramexane mesylate
Intervention Description
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
Time Frame
29 weeks
Title
safety parameters
Time Frame
29 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.)
Facility Information:
Facility Name
AZ Sint Lucas, ENT department
City
Assebroek-Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
University Hospital Brussels, ENT department
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Clinique Universitaire Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Dr. Henri HABERMAN
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Sint Lucas, ENT department
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Centre hospitalier de jolimont
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
University Hospital Leuven, ENT Department
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Liege Service ORL
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Medico
City
Chodov
State/Province
Prague
Country
Czech Republic
Facility Name
Prof. MUDr. Ivo Šlapák, CSc
City
Brno
ZIP/Postal Code
60200
Country
Czech Republic
Facility Name
Teaching University Hospital, ORL klinika
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Nemocnice Havlíčkův Brod
City
Havlíčkův Brod
ZIP/Postal Code
58022
Country
Czech Republic
Facility Name
ORL - Otorynolaryngologické oddělení
City
Jihlava
ZIP/Postal Code
58633
Country
Czech Republic
Facility Name
ORL oddělení, Karlovarská krajská nemocncie a.s.
City
Karlovy Vary
ZIP/Postal Code
36066
Country
Czech Republic
Facility Name
Oblastní nemocnice Kladno a.s.
City
Kladno
ZIP/Postal Code
27259
Country
Czech Republic
Facility Name
Pro-audio,s.r.o.-private ENT clinic
City
Mladá Boleslav
ZIP/Postal Code
29301
Country
Czech Republic
Facility Name
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
City
Praha
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
ORL oddělení , Karlovarská krajská nemocnice a. s.
City
Sokolov
ZIP/Postal Code
35601
Country
Czech Republic
Facility Name
Dr. Ebbo
City
Issy les moulineaux
ZIP/Postal Code
92130
Country
France
Facility Name
Dr. Sarfati
City
La seyne sur Mer
ZIP/Postal Code
83500
Country
France
Facility Name
Centre Hospitalier de Bretagne Sud Service
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
BONFILS
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
OHRESSER
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Nord
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
FRAYSSE
City
Toulouse cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Service ORL CHU
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Hopital Paul BROUSSE Polyclinique
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Andromed Breda
City
Breda
ZIP/Postal Code
4811 VL
Country
Netherlands
Facility Name
Andromed Leiden
City
Leiderdorp
ZIP/Postal Code
2352 RA
Country
Netherlands
Facility Name
Rijnland Ziekenhuis, ENT department
City
Leiderdorp
ZIP/Postal Code
2353 GA
Country
Netherlands
Facility Name
Adromed Nijmegen
City
Nijmegen
ZIP/Postal Code
6533 HL
Country
Netherlands
Facility Name
Andromed Rotterdam
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Andromed Rotterdam
City
Rotterdam
ZIP/Postal Code
HC 3021
Country
Netherlands
Facility Name
Andromed Oost
City
Velp
ZIP/Postal Code
6883 ES
Country
Netherlands
Facility Name
Andromed Zoetermeer
City
Zoetermeer
ZIP/Postal Code
2724 EK
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-279
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
City
Gdansk
ZIP/Postal Code
80-288
Country
Poland
Facility Name
Szpital Miejski im. J.Brudzinskiego
City
Gdynia
ZIP/Postal Code
81-348
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
NZOZ Specjalistyczne Centrum Medyczne Nowomed
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
City
Krakow
ZIP/Postal Code
31-534
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
City
Krakow
ZIP/Postal Code
31-636
Country
Poland
Facility Name
Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
91-153
Country
Poland
Facility Name
Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi
City
Lodz
ZIP/Postal Code
91-348
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Instytut Fizjologii i Patologii Sluchu
City
Warszawa
ZIP/Postal Code
01-943
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-369
Country
Poland
Facility Name
Louis Leipoldt Mediclinic
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Lakeview Hospital
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Dr. A. Viljoen
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
GCT Eastmed Clinical Trial centre
City
Pretoria
ZIP/Postal Code
0186
Country
South Africa
Facility Name
Constantiaberg Medi Clinic
City
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Dr. J. Steer
City
Wynberg
ZIP/Postal Code
7800
Country
South Africa

12. IPD Sharing Statement

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

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