Effect of Gabapentin on Idiopathic Subjective Tinnitus
|ClinicalTrials.gov Identifier: NCT00555776|
Recruitment Status : Unknown
Verified August 2008 by Islamic Azad University of Mashhad.
Recruitment status was: Active, not recruiting
First Posted : November 9, 2007
Last Update Posted : January 6, 2009
|Condition or disease||Intervention/treatment||Phase|
|Subjective Tinnitus||Drug: Gabapentin Drug: placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||April 2008|
|Estimated Study Completion Date :||October 2008|
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
- 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 ]
- Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|