NCT00257270

Brief Summary

This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations: Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group, but would be less effective in the non-trauma group.'

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
Last Updated

November 22, 2005

Status Verified

June 1, 2005

First QC Date

November 18, 2005

Last Update Submit

November 18, 2005

Conditions

Tinnitus

Keywords

ChronicTinnitusAcoustic traumaPsychophysicsLoudness matchgabapentin

Outcome Measures

Primary Outcomes (3)

  • Psychophysical loudness match of tinnitus to broad band noise and pure tones.

  • Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.

  • The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.

Secondary Outcomes (1)

  • Quality of Life survey (SF36-QOL)

Interventions

gabapentinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-pulsatile tinnitus present \> 1 year
  • Tinnitus Handicap Questionnaire score \> 30
  • ability to perform psychophysical matching procedure

You may not qualify if:

  • evidence of depression
  • renal insufficiency
  • conductive hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

TinnitusBronchiolitis Obliterans SyndromeHearing Loss, Noise-Induced

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesHearing Loss, SensorineuralHearing Loss

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Carol Bauer, MD

    Southern Illinois University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 22, 2005

Study Start

August 1, 2003

Study Completion

January 1, 2005

Last Updated

November 22, 2005

Record last verified: 2005-06