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Effect of Gabapentin on Idiopathic Subjective Tinnitus

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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
Sponsor:
Information provided by:
Islamic Azad University of Mashhad

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.

Condition or disease Intervention/treatment Phase
Subjective Tinnitus Drug: Gabapentin Drug: placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Randomly,half of the subjects are given Gabapentin.
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
Placebo Comparator: 2
Randomly,half of the subjects receive placebo.
Drug: placebo
placebo is given with the same definition as Gabapentin



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555776


Locations
Iran, Islamic Republic of
ENT department of Mashhad Azad medical university
Mashhad, Khorasan razavi, Iran, Islamic Republic of, 91786 56553
Sponsors and Collaborators
Islamic Azad University of Mashhad
Investigators
Principal Investigator: Mahboobeh Adami Dehkordi, MD ENT department of Mashhad azad university of mashhad

Publications of Results:
Responsible Party: Dr.Mahboobeh Adami Dehkordi, Assisstant professor
ClinicalTrials.gov Identifier: NCT00555776     History of Changes
Other Study ID Numbers: Gaba-tinntus-145
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: January 6, 2009
Last Verified: August 2008

Keywords provided by Islamic Azad University of Mashhad:
tinnitus
gabapentin

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents