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Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography (piribedil)

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
piribedil
Sponsored by
Faculdade de Medicina de Valenca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, piribedil, acoustic otoemissions, ECoG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • tinnitus for more than 6 months
  • THI > 38
  • no central acting drugs in the last 6 months
  • tympanogram type A-n

Exclusion Criteria:

  • vascular and muscular tinnitus
  • concomitant TMJ disorders
  • abnormal otoscopy
  • mixed and conductive hearing losses

Sites / Locations

  • OTOSUL,Otorrinolaringologia Sul-Fluminense

Outcomes

Primary Outcome Measures

THI - Tinnitus Handicap Inventory

Secondary Outcome Measures

VAS - Visual Analog Scale

Full Information

First Posted
December 26, 2007
Last Updated
March 6, 2008
Sponsor
Faculdade de Medicina de Valenca
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1. Study Identification

Unique Protocol Identification Number
NCT00591994
Brief Title
Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
Acronym
piribedil
Official Title
Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Faculdade de Medicina de Valenca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, piribedil, acoustic otoemissions, ECoG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
piribedil
Intervention Description
50 mg once a day, after lunch 3 month therapy
Primary Outcome Measure Information:
Title
THI - Tinnitus Handicap Inventory
Time Frame
Months 3 and 6
Secondary Outcome Measure Information:
Title
VAS - Visual Analog Scale
Time Frame
Months 3 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: tinnitus for more than 6 months THI > 38 no central acting drugs in the last 6 months tympanogram type A-n Exclusion Criteria: vascular and muscular tinnitus concomitant TMJ disorders abnormal otoscopy mixed and conductive hearing losses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo R Figueiredo, M.D.,M.Sc
Organizational Affiliation
Faculdade de Medicina de Valença
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andréia A Azevedo, M.D.
Organizational Affiliation
Otosul -Otorrinolaringologia Sul-Fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
OTOSUL,Otorrinolaringologia Sul-Fluminense
City
Volta Redonda
State/Province
RJ
ZIP/Postal Code
27255-650
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19574947
Citation
de Azevedo AA, Langguth B, de Oliveira PM, Rodrigues Figueiredo R. Tinnitus treatment with piribedil guided by electrocochleography and acoustic otoemissions. Otol Neurotol. 2009 Aug;30(5):676-80. doi: 10.1097/MAO.0b013e3181ab8fd5.
Results Reference
derived

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Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

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