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
PHASE4
50 participants
INTERVENTIONAL
2009-02-28
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Lactose placebo
1x/day
Lactose placebo
Lactose used as placebo
Deanxit
Deanxit
Deanxit 1x/day
Interventions
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Deanxit
Deanxit 1x/day
Lactose placebo
Lactose used as placebo
Eligibility Criteria
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Inclusion Criteria
* unilateral or bilateral tinnitus
* VAS ≥ 4
* cochleair origin tinnitus
* tinnitus present 3 months or more
* age 18y or more
* intake Rivotril 1mg/d
* patient 'able to cooperate'
* patient able to fill in TQ en VAS
* No pontine angle pathology on MRI
Exclusion Criteria
* pregnancy or breast feeding
* contra-indications Deanxit
* recovery myocard infarct
* conduction disorder His
* untreated glaucoma
* MAO inhibitors: 15d stop
* otosclerosis
* middle ear pathologies
* Ménière
* somatic tinnitus
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Antwerp University Hospital
Principal Investigators
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Olivier Meeus, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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Antwerp University Hospital
Antwerp, Antwerp, Belgium
Countries
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Other Identifiers
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8/46/260
Identifier Type: -
Identifier Source: org_study_id
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