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The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.
Tinnitus is the perception of sound in the absence of acoustic stimulation. It can be subjective or objective. .
Despite numerous researches,no effective treatment for people who suffer from tinnitus has yet been stablished.
As there are many evidences suggesting that loss of inhibition in the central nervous system may be responsible for many aspects of auditory dysfunction,including tinnitus; and as Gabapentin (Neurontin), a gama-aminobutyric acid (GABA) analogue, is an effective medication in conditions where inhibition in the CNS is impaired; we guess that Gabapentin might be useful for treating idiopathic subjective tinnitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Randomly,half of the subjects are given Gabapentin. |
|
| 2 | Placebo Comparator | Randomly,half of the subjects receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin, 600 mg bid for the first two weeks, increased to a maximum dose of 1800 mg per day during the next 6 weeks if necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin. | two months |
| Measure | Description | Time Frame |
|---|---|---|
| Relieve of complications of tinnitus, such as sleep difficulties. | two months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahboobeh Adami Dehkordi, MD | ENT department of Mashhad azad university of mashhad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT department of Mashhad Azad medical university | Mashhad | Razavi Khorasan Province | 91786 56553 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17960408 | Result | Bakhshaee M, Ghasemi M, Azarpazhooh M, Khadivi E, Rezaei S, Shakeri M, Tale M. Gabapentin effectiveness on the sensation of subjective idiopathic tinnitus: a pilot study. Eur Arch Otorhinolaryngol. 2008 May;265(5):525-30. doi: 10.1007/s00405-007-0504-9. Epub 2007 Oct 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 29, 2010 | |
| Reset | Jan 20, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 29, 2010 | Jan 20, 2011 |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| placebo | Drug | placebo is given with the same definition as Gabapentin |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |