Effect of Gabapentin on Idiopathic Subjective Tinnitus | RxWiki

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.
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
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
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)	Active Comparator: 1 Randomly,half of the subjects are given Gabapentin. Placebo Comparator: 2 Randomly,half of the subjects receive placebo.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
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
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

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