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Clinical Trials/NCT00841230
NCT00841230
Completed
Phase 4

Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

University Hospital, Antwerp1 site in 1 country50 target enrollmentFebruary 2009

Overview

Phase
Phase 4
Intervention
Lactose placebo
Conditions
Tinnitus
Sponsor
University Hospital, Antwerp
Enrollment
50
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
July 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • pure tone, narrow band noise or polyphonic tinnitus
  • unilateral or bilateral tinnitus
  • 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

  • pulsatile tinnitus
  • pregnancy or breast feeding
  • contra-indications Deanxit
  • recovery myocard infarct
  • conduction disorder His
  • untreated glaucoma
  • MAO inhibitors: 15d stop
  • otosclerosis
  • middle ear pathologies
  • somatic tinnitus

Arms & Interventions

Lactose placebo

1x/day

Intervention: Lactose placebo

Deanxit

Intervention: Deanxit

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: 3 weeks, 6 weeks

Study Sites (1)

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