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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

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE January 11, 2008
Last Update Posted Date March 7, 2008
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
THI - Tinnitus Handicap Inventory [ Time Frame: Months 3 and 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00591994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
VAS - Visual Analog Scale [ Time Frame: Months 3 and 6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
Official Title  ICMJE Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE Drug: piribedil
50 mg once a day, after lunch 3 month therapy
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2007)
100
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00591994
Other Study ID Numbers  ICMJE OTOSUL 01/2007
FMV 01/2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andréia Aparecida de Azevedo, M.D., OTOSUL
Study Sponsor  ICMJE Faculdade de Medicina de Valenca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Faculdade de Medicina de Valenca
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP