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Effect of Gabapentin on Idiopathic Subjective Tinnitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Islamic Azad University of Mashhad.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Islamic Azad University of Mashhad
ClinicalTrials.gov Identifier:
NCT00555776
First received: November 8, 2007
Last updated: January 5, 2009
Last verified: August 2008

November 8, 2007
January 5, 2009
January 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by thre patient's scoring it from one to ten, before and after prescribing Gabapentin. [ Time Frame: two months ]
Complete list of historical versions of study NCT00555776 on ClinicalTrials.gov Archive Site
Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ] [ Designated as safety issue: Yes ]
Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ]
Not Provided
Not Provided
 
Effect of Gabapentin on Idiopathic Subjective Tinnitus
Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Subjective Tinnitus
  • 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 Name: Neurontine
  • Drug: placebo
    placebo is given with the same definition as Gabapentin
  • Active Comparator: 1
    Randomly,half of the subjects are given Gabapentin.
    Intervention: Drug: Gabapentin
  • Placebo Comparator: 2
    Randomly,half of the subjects receive placebo.
    Intervention: Drug: placebo
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. 2007 Oct 25; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
October 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00555776
Gaba-tinntus-145
Yes
Dr.Mahboobeh Adami Dehkordi, Assisstant professor
Islamic Azad University of Mashhad
Not Provided
Principal Investigator: Mahboobeh Adami Dehkordi, MD ENT department of Mashhad azad university of mashhad
Islamic Azad University of Mashhad
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP