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
43 participants
INTERVENTIONAL
2006-10-31
2007-05-31
Brief Summary
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Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic tinnitus.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
Arm 2
Placebo
Placebo BID p.o. for 12 weeks + 4 weeks follow-up
Interventions
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Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
Placebo
Placebo BID p.o. for 12 weeks + 4 weeks follow-up
Eligibility Criteria
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Inclusion Criteria
* No treatment of tinnitus within 4 weeks prior to study entry
* Duration of tinnitus \> 3 months
Exclusion Criteria
* Intermittent tinnitus
* History of M. Menieré
* History of conductive deafness
* History of psychogenic deafness
* History of tumors of the middle ear, inner ear or cerebella-pontine angle (malignant and non malignant)
* Patients diagnosed of multiple sclerosis
* History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
* Nitrates or nitric oxide donors
* Any other concurrent treatment of tinnitus during study
* pregnant and breast-feeding women
* women with child-bearing potential not using adequate birth control method (Note: as adequate method of birth control oral contraception, spiral or sexual abstinence is recommended)
18 Years
64 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Berlin, Berlin / 285, Germany
Countries
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Related Links
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click here and search for Bayer product information provided by the EMA
Other Identifiers
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2006-000463-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12049
Identifier Type: -
Identifier Source: org_study_id