Status:
COMPLETED
Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo 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 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
- 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.)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00772980
Start Date
November 1 2008
End Date
June 1 2010
Last Update
July 1 2010
Active Locations (56)
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1
AZ Sint Lucas, ENT department
Assebroek-Brugge, Belgium, 8310
2
University Hospital Brussels, ENT department
Brussels, Belgium, 1090
3
Clinique Universitaire Saint-Luc
Brussels, Belgium, 1200
4
Dr. Henri HABERMAN
Brussels, Belgium, 1200