Effect of Gabapentin on Idiopathic Subjective Tinnitus

January 5, 2009 updated by: Islamic Azad University of Mashhad

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan razavi
      • Mashhad, Khorasan razavi, Iran, Islamic Republic of, 91786 56553
        • ENT department of Mashhad Azad medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Neurontine
Placebo Comparator: 2
Randomly,half of the subjects receive placebo.
Drug: placebo
placebo is given with the same definition as Gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
two months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relieve of complications of tinnitus, such as sleep difficulties.
Time Frame: two months
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamic Azad University of Mashhad

Investigators

  • Principal Investigator: Mahboobeh Adami Dehkordi, MD, ENT department of Mashhad azad university of mashhad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

April 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria

November 8, 2007

First Posted (Estimate)

November 9, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 2009

Last Update Submitted That Met QC Criteria

January 5, 2009

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gaba-tinntus-145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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