Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-06 @ 10:53 PM
Study NCT ID:
NCT00591994
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010891', 'term': 'Piribedil'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'lastUpdateSubmitDate': '2008-03-06', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'THI - Tinnitus Handicap Inventory', 'timeFrame': 'Months 3 and 6'}], 'secondaryOutcomes': [{'measure': 'VAS - Visual Analog Scale', 'timeFrame': 'Months 3 and 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tinnitus', 'piribedil', 'acoustic otoemissions', 'ECoG'], 'conditions': ['Tinnitus']}, 'referencesModule': {'references': [{'pmid': '19574947', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tinnitus for more than 6 months\n* THI \\> 38\n* no central acting drugs in the last 6 months\n* tympanogram type A-n\n\nExclusion Criteria:\n\n* vascular and muscular tinnitus\n* concomitant TMJ disorders\n* abnormal otoscopy\n* mixed and conductive hearing losses'}, 'identificationModule': {'nctId': 'NCT00591994', 'acronym': 'piribedil', 'briefTitle': 'Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Medicina de Valenca'}, 'officialTitle': 'Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography', 'orgStudyIdInfo': {'id': 'OTOSUL 01/2007'}, 'secondaryIdInfos': [{'id': 'FMV 01/2006'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'piribedil', 'type': 'DRUG', 'description': '50 mg once a day, after lunch 3 month therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27255-650', 'city': 'Volta Redonda', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'OTOSUL,Otorrinolaringologia Sul-Fluminense', 'geoPoint': {'lat': -22.52306, 'lon': -44.10417}}], 'overallOfficials': [{'name': 'Ricardo R Figueiredo, M.D.,M.Sc', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculdade de Medicina de Valença'}, {'name': 'Andréia A Azevedo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Otosul -Otorrinolaringologia Sul-Fluminense'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Medicina de Valenca', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Andréia Aparecida de Azevedo, M.D.', 'oldOrganization': 'OTOSUL'}}}}