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Sponsored by: |
Merz Pharmaceuticals GmbH |
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Information provided by: | Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00739635 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus |
Estimated Enrollment: | 400 |
Study Start Date: | September 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
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2: Placebo Comparator |
Drug: Placebo
Double-blind treatment period of 17 weeks placebo
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clariness Clariness | tinnitus@clinlife.net |
Austria | |
Dr. Heger | Recruiting |
Linz, Austria | |
Germany | |
Recruiting | |
Munich, Germany | |
Spain | |
Recruiting | |
Barcelona, Spain | |
United Kingdom | |
Recruiting | |
Leicester, United Kingdom |
Study ID Numbers: | MRZ 92579/TI/3001, EudraCT Number 2007-007835-16 |
Study First Received: | August 21, 2008 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00739635 History of Changes |
Health Authority: | Austria: Federal Office for Safety in Health Care |
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Neurologic Manifestations Ear Diseases Tinnitus |
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Nervous System Diseases Neurologic Manifestations Ear Diseases Tinnitus |