Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
431 participants
INTERVENTIONAL
2005-10-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neramexane 25mg/d
Neramexane
Oral tablets, duration: 16 weeks
Neramexane 50mg/d
Neramexane
Oral tablets, duration: 16 weeks
Neramexane 75mg/d
Neramexane
Oral tablets, duration: 16 weeks
Placebo
Placebo
Oral tablets, duration: 16 weeks
Interventions
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Neramexane
Oral tablets, duration: 16 weeks
Placebo
Oral tablets, duration: 16 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Merz Pharmaceuticals GmbH
Principal Investigators
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Markus Suckfüll, MD PhD Ass. Prof.
Role: STUDY_CHAIR
Ludwig-Maximilians - University of Munich
Locations
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Vienna, , Austria
Munich, , Germany
Countries
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References
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Suckfull M, Althaus M, Ellers-Lenz B, Gebauer A, Gortelmeyer R, Jastreboff PJ, Moebius HJ, Rosenberg T, Russ H, Wirth Y, Krueger H. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus. BMC Ear Nose Throat Disord. 2011 Jan 11;11:1. doi: 10.1186/1472-6815-11-1.
Gortelmeyer R, Schmidt J, Suckfull M, Jastreboff P, Gebauer A, Kruger H, Wittmann W. Assessment of tinnitus-related impairments and disabilities using the German THI-12: sensitivity and stability of the scale over time. Int J Audiol. 2011 Aug;50(8):523-9. doi: 10.3109/14992027.2011.578591.
Other Identifiers
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MRZ 92579-0508/1
Identifier Type: -
Identifier Source: org_study_id
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