Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT00317850
Status:
TERMINATED
Last Update Posted:
2012-03-02
First Post:
2006-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gabapentin for the Treatment of Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 160}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2012-02-29', 'studyFirstSubmitDate': '2006-04-21', 'studyFirstSubmitQcDate': '2006-04-21', 'lastUpdatePostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus Handicap Inventory Score from Baseline to Week 8'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory Score from Baseline to Week 8'}, {'measure': 'Brief Symptom Inventory Score from Baseline to Week 8'}, {'measure': 'Epworth Sleepiness Scale Score from Baseline to Week 8'}]}, 'conditionsModule': {'conditions': ['Tinnitus']}, 'referencesModule': {'references': [{'pmid': '17438255', 'type': 'DERIVED', 'citation': 'Piccirillo JF, Finnell J, Vlahiotis A, Chole RA, Spitznagel E Jr. Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7. doi: 10.1001/archotol.133.4.390.'}]}, 'descriptionModule': {'briefSummary': "The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults, between the ages of 18 and 70\n* Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater\n* Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.\n\nExclusion Criteria:\n\n* The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled.\n* Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = \\[(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)\\] X 0.85,whereCcr indicates creatinine clearance.\n* Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone\n* Patients with any serious or unstable medical or psychiatric condition.\n* Patients whose ability to give informed consent is in question."}, 'identificationModule': {'nctId': 'NCT00317850', 'briefTitle': 'Gabapentin for the Treatment of Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Gabapentin for the Relief of Idiopathic Subjective Tinnitus', 'orgStudyIdInfo': {'id': 'R01DC006253-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DC006253-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DC006253', 'link': 'https://reporter.nih.gov/quickSearch/R01DC006253', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Gabapentin (Neurontin)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jay F Piccirillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology, Director of Clinical Outcomes Research Office', 'investigatorFullName': 'Jay F. Piccirillo, MD', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}