Gabapentin for the Treatment of Tinnitus
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| ClinicalTrials.gov Identifier: NCT00317850 |
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Recruitment Status :
Terminated
First Posted : April 25, 2006
Last Update Posted : March 2, 2012
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Sponsor:
Washington University School of Medicine
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tinnitus | Drug: Gabapentin (Neurontin) | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Gabapentin for the Relief of Idiopathic Subjective Tinnitus |
| Study Start Date : | April 2004 |
| Study Completion Date : | February 2006 |
Primary Outcome Measures :
- Tinnitus Handicap Inventory Score from Baseline to Week 8
Secondary Outcome Measures :
- 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
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317850
Sponsors and Collaborators
Washington University School of Medicine
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
| Principal Investigator: | Jay F Piccirillo, MD | Washington University School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jay F. Piccirillo, MD, Professor of Otolaryngology, Director of Clinical Outcomes Research Office, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00317850 |
| Other Study ID Numbers: |
R01DC006253-01 ( U.S. NIH Grant/Contract ) R01DC006253 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 25, 2006 Key Record Dates |
| Last Update Posted: | March 2, 2012 |
| Last Verified: | February 2012 |
Additional relevant MeSH terms:
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Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents |