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Effect of Gabapentin on Idiopathic Subjective Tinnitus

Primary Purpose

Subjective Tinnitus

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Gabapentin

placebo

About this trial

This is an interventional treatment trial for Subjective Tinnitus focused on measuring tinnitus, gabapentin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ENT department of Mashhad Azad medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Randomly,half of the subjects are given Gabapentin.

Randomly,half of the subjects receive placebo.

Outcomes

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.

Secondary Outcome Measures

Relieve of complications of tinnitus, such as sleep difficulties.

Full Information

NCT ID

NCT00555776

First Posted

November 8, 2007

Last Updated

January 5, 2009

Sponsor

Islamic Azad University of Mashhad

1. Study Identification

Unique Protocol Identification Number

NCT00555776

Brief Title

Effect of Gabapentin on Idiopathic Subjective Tinnitus

Official Title

Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

April 2008 (Anticipated)

Study Completion Date

October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Islamic Azad University of Mashhad

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subjective Tinnitus

Keywords

tinnitus, gabapentin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Randomly,half of the subjects are given Gabapentin.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Randomly,half of the subjects receive placebo.

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Other Intervention Name(s)

Neurontine

Intervention Description

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

Intervention Name(s)

placebo

Intervention Description

placebo is given with the same definition as Gabapentin

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Relieve of complications of tinnitus, such as sleep difficulties.

Time Frame

two months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahboobeh Adami Dehkordi, MD

Organizational Affiliation

ENT department of Mashhad azad university of mashhad

Official's Role

Principal Investigator

Facility Information:

Facility Name

ENT department of Mashhad Azad medical university

City

Mashhad

State/Province

Khorasan razavi

ZIP/Postal Code

91786 56553

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

17960408

Citation

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.

Results Reference

result

Learn more about this trial

Effect of Gabapentin on Idiopathic Subjective Tinnitus

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