Deanxit and Rivotril in Tinnitus Patients

Phase 4

Completed

• Conditions: Tinnitus
• Interventions: Drug: Lactose placebo; Drug: Deanxit

• Registration Number: NCT00841230
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-30
• Study Start: 2009-02
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-10
• Last Update Posted: 2009-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• pure tone, narrow band noise or polyphonic tinnitus

• 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

• 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
• Ménière
• somatic tinnitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactose placebo	Lactose placebo	1x/day
Deanxit	Deanxit	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	3 weeks, 6 weeks

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium