Effect of Gabapentin on Idiopathic Subjective Tinnitus - Full Text View

Sponsor:	Islamic Azad University of Mashhad
Information provided by:	Islamic Azad University of Mashhad
ClinicalTrials.gov Identifier:	NCT00555776

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	Intervention	Phase
Subjective Tinnitus	Drug: Gabapentin Drug: placebo	Phase II

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Islamic Azad University of Mashhad:

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 ]

Secondary Outcome Measures:

Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
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)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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]

Responsible Party:	Dr.Mahboobeh Adami Dehkordi, Assisstant professor
ClinicalTrials.gov Identifier:	NCT00555776 History of Changes
Other Study ID Numbers:	Gaba-tinntus-145
Study First Received:	November 8, 2007
Last Updated:	January 5, 2009
Health Authority:	Iran: Ministry of Health

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012