Effect of Gabapentin on Idiopathic Subjective Tinnitus

NCT ID: NCT00555776

Last Updated: 2009-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.

Detailed Description

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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.

Conditions

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Subjective Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Randomly,half of the subjects are given Gabapentin.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

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.

2

Randomly,half of the subjects receive placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo is given with the same definition as Gabapentin

Interventions

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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.

Intervention Type DRUG

placebo

placebo is given with the same definition as Gabapentin

Intervention Type DRUG

Other Intervention Names

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Neurontine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Islamic Azad University of Mashhad

OTHER

Sponsor Role lead

Responsible Party

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Assisstant professor

Principal Investigators

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Mahboobeh Adami Dehkordi, MD

Role: PRINCIPAL_INVESTIGATOR

ENT department of Mashhad azad university of mashhad

Locations

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ENT department of Mashhad Azad medical university

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

References

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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. 2008 May;265(5):525-30. doi: 10.1007/s00405-007-0504-9. Epub 2007 Oct 25.

Reference Type RESULT
PMID: 17960408 (View on PubMed)

Other Identifiers

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Gaba-tinntus-145

Identifier Type: -

Identifier Source: org_study_id

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