Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

NCT ID: NCT00591994

Last Updated: 2008-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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piribedil

50 mg once a day, after lunch 3 month therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Medicina de Valenca

OTHER

Sponsor Role lead

Responsible Party

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OTOSUL

Principal Investigators

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Ricardo R Figueiredo, M.D.,M.Sc

Role: STUDY_CHAIR

Faculdade de Medicina de Valença

Andréia A Azevedo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Otosul -Otorrinolaringologia Sul-Fluminense

Locations

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OTOSUL,Otorrinolaringologia Sul-Fluminense

Volta Redonda, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 19574947 (View on PubMed)

Other Identifiers

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FMV 01/2006

Identifier Type: -

Identifier Source: secondary_id

OTOSUL 01/2007

Identifier Type: -

Identifier Source: org_study_id

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