Effect of Gabapentin on Idiopathic Subjective Tinnitus
Recruitment status was: Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus|
- 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 ]
- Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||October 2008|
|Estimated Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Randomly,half of the subjects are given 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 Name: Neurontine
Placebo Comparator: 2
Randomly,half of the subjects receive placebo.
placebo is given with the same definition as Gabapentin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555776
|Iran, Islamic Republic of|
|ENT department of Mashhad Azad medical university|
|Mashhad, Khorasan razavi, Iran, Islamic Republic of, 91786 56553|
|Principal Investigator:||Mahboobeh Adami Dehkordi, MD||ENT department of Mashhad azad university of mashhad|