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Deanxit and Rivotril in Tinnitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841230
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : August 11, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Deanxit Drug: Lactose placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril
Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Placebo Comparator: Lactose placebo
Drug: Lactose placebo
Lactose used as placebo

Experimental: Deanxit Drug: Deanxit
Deanxit 1x/day

Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 3 weeks, 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00841230

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Antwerp University Hospital
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
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Principal Investigator: Olivier Meeus, MD University Hospital, Antwerp
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Responsible Party: Prof Dr P H Van de Heyning, Antwerp University Hospital Identifier: NCT00841230    
Other Study ID Numbers: 8/46/260
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009
Keywords provided by University Hospital, Antwerp:
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases