Overview

This trial is active, not recruiting.

Condition subjective tinnitus
Treatments gabapentin, placebo
Phase phase 2
Sponsor Islamic Azad University of Mashhad
Start date January 2007
End date April 2008
Trial size 70 participants
Trial identifier NCT00555776, Gaba-tinntus-145

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Randomly,half of the subjects are given Gabapentin.
gabapentin Neurontine
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.
(Placebo Comparator)
Randomly,half of the subjects receive placebo.
placebo
placebo is given with the same definition as Gabapentin

Primary Outcomes

Measure
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 Outcomes

Measure
Relieve of complications of tinnitus, such as sleep difficulties.
time frame: two months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus
Principal investigator Mahboobeh Adami Dehkordi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Islamic Azad University of Mashhad.