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Gabapentin for the Treatment of Tinnitus
This study has been terminated.
Study NCT00317850   Information provided by National Institute on Deafness and Other Communication Disorders (NIDCD)
First Received: April 21, 2006   Last Updated: May 12, 2006   History of Changes

April 21, 2006
May 12, 2006
April 2004
 
Tinnitus Handicap Inventory Score from Baseline to Week 8
Same as current
Complete list of historical versions of study NCT00317850 on ClinicalTrials.gov Archive Site
  • Beck Depression Inventory Score from Baseline to Week 8
  • Brief Symptom Inventory Score from Baseline to Week 8
  • Epworth Sleepiness Scale Score from Baseline to Week 8
Same as current
 
Gabapentin for the Treatment of Tinnitus
Gabapentin for the Relief of Idiopathic Subjective Tinnitus

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.

 
Phase II, Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Tinnitus
Drug: Gabapentin (Neurontin)
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
160
February 2006
 

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00317850
 
R01 DC006253-01
National Institute on Deafness and Other Communication Disorders (NIDCD)
 
Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
National Institute on Deafness and Other Communication Disorders (NIDCD)
May 2006

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