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ClinicalTrials.gov Identifier: NCT00317850
Recruitment Status :
First Posted : April 25, 2006
Last Update Posted : March 2, 2012
Washington University School of Medicine
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
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.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adults, between the ages of 18 and 70
Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater
Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.
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.
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.
Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone
Patients with any serious or unstable medical or psychiatric condition.
Patients whose ability to give informed consent is in question.