Effect of Gabapentin on Idiopathic Subjective Tinnitus
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus. |
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Condition | Subjective Tinnitus |
Intervention | Drug: Gabapentin Drug: placebo |
Phase | Phase 2 |
Sponsor | Islamic Azad University of Mashhad |
Responsible Party | Islamic Azad University of Mashhad |
ClinicalTrials.gov Identifier | NCT00555776 |
First Received | November 8, 2007 |
Last Updated | January 5, 2009 |
Last verified | August 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | November 8, 2007 |
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Last Updated Date | January 5, 2009 |
Start Date | January 2007 |
Estimated Primary Completion Date | October 2008 |
Current Primary Outcome Measures | 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. [Time Frame: two months] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Relieve of complications of tinnitus, such as sleep difficulties. [Time Frame: two months] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Effect of Gabapentin on Idiopathic Subjective Tinnitus |
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Official Title | Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus |
Brief Summary | The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Subjective Tinnitus |
Intervention | Drug: Gabapentin 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. Other Names: NeurontineDrug: placebo placebo is given with the same definition as Gabapentin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 70 |
Estimated Completion Date | October 2008 |
Estimated Primary Completion Date | April 2008 |
Eligibility Criteria | Inclusion Criteria: - patients with subjective idiopathic tinnitus Exclusion Criteria: - tinnitus with known underlying cause - pregnant women and patients younger than 18 or older than 75 years - patients with impaired renal function |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Iran, Islamic Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00555776 |
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Other Study ID Numbers | Gaba-tinntus-145 |
Has Data Monitoring Committee | Yes |
Information Provided By | Islamic Azad University of Mashhad |
Study Sponsor | Islamic Azad University of Mashhad |
Collaborators | Not Provided |
Investigators | Principal Investigator: Mahboobeh Adami Dehkordi, MD ENT department of Mashhad azad university of mashhad |
Verification Date | August 2008 |
Locations[ + expand ][ + ]
ENT department of Mashhad Azad medical university | Mashhad, Khorasan razavi, Iran, Islamic Republic of, 91786 56553 |
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