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

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ClinicalTrials.gov Identifier: NCT00591994
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : March 7, 2008
Sponsor:
Information provided by:
Faculdade de Medicina de Valenca

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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: piribedil Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
Study Start Date : November 2006
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources


Intervention Details:
    Drug: piribedil
    50 mg once a day, after lunch 3 month therapy


Primary Outcome Measures :
  1. THI - Tinnitus Handicap Inventory [ Time Frame: Months 3 and 6 ]

Secondary Outcome Measures :
  1. VAS - Visual Analog Scale [ Time Frame: Months 3 and 6 ]


Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00591994


Locations
Brazil
OTOSUL,Otorrinolaringologia Sul-Fluminense
Volta Redonda, RJ, Brazil, 27255-650
Sponsors and Collaborators
Faculdade de Medicina de Valenca
Investigators
Study Chair: Ricardo R Figueiredo, M.D.,M.Sc Faculdade de Medicina de Valença
Principal Investigator: Andréia A Azevedo, M.D. Otosul -Otorrinolaringologia Sul-Fluminense

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andréia Aparecida de Azevedo, M.D., OTOSUL
ClinicalTrials.gov Identifier: NCT00591994     History of Changes
Other Study ID Numbers: OTOSUL 01/2007
FMV 01/2006
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: December 2007

Keywords provided by Faculdade de Medicina de Valenca:
tinnitus
piribedil
acoustic otoemissions
ECoG

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Piribedil
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs