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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00772980 |
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Date of registration:
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13/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00772980 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Czech Republic
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France
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Netherlands
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Poland
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South Africa
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Key inclusion & exclusion criteria
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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.)
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Subjective Tinnitus
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Intervention(s)
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Drug: Neramexane mesylate
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
[Time Frame: 29 weeks]
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safety parameters
[Time Frame: 29 weeks]
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Secondary ID(s)
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EudraCT Number 2008-000639-16
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MRZ 92579/TI/3002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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