Status:
COMPLETED
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Subjective Tinnitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT00739635
Start Date
September 1 2008
End Date
February 1 2010
Last Update
February 4 2016
Active Locations (54)
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1
Krankenhaus der Elisabethinen
Graz, Austria, A-8020
2
Bezirkskrankenhaus Kufstein
Kufstein, Austria, A-6330
3
A. ö. Krankenhaus der Elisabethinen Linz
Linz, Austria, A-4010
4
Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, Austria, A-5020