Deanxit and Rivotril in Tinnitus Patients

August 10, 2009 updated by: University Hospital, Antwerp

Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Lactose placebo
1x/day
Drug: Lactose placebo
Lactose used as placebo
Experimental: Deanxit
Drug: Deanxit
Deanxit 1x/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale
Time Frame: 3 weeks, 6 weeks
3 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Olivier Meeus, MD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2009

Last Update Submitted That Met QC Criteria

August 10, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8/46/260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe