Subjective TinnitusPhase 2NCT00555776
Effect of Gabapentin on Idiopathic Subjective Tinnitus
A Phase 2 study testing Gabapentin in people with Subjective Tinnitus, run by Islamic Azad University of Mashhad at 1 site in Iran.
Trial summary
The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subjective Tinnitus
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Jan 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with subjective idiopathic tinnitus
Who cannot join
- tinnitus with known underlying cause
- pregnant women and patients younger than 18 or older than 75 years
- patients with impaired renal function
Trial locations and contacts
1 site in 1 country.
Iran1 site
ENT department of Mashhad Azad medical university
Mashhad, Razavi Khorasan Province, 91786 56553
About this study
Official title: 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.
Read the 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.
- Conditions
- Subjective Tinnitus
- Being tested
- Gabapentin, placebo
- Keywords
- tinnitus, gabapentin
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called 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.
placeboDrug
placebo is given with the same definition as Gabapentin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Randomly,half of the subjects are given Gabapentin. Receives: Drug: Gabapentin |
| 2 | Placebo comparator | Randomly,half of the subjects receive placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months
Secondary outcomes (1)
Relieve of complications of tinnitus, such as sleep difficulties.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjective TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University of Mashhad
- Sponsor type
- University, hospital or other
- Investigators
- Mahboobeh Adami Dehkordi, MD, Principal investigator, ENT department of Mashhad azad university of mashhad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555776
- Sponsor's protocol ID
- Gaba-tinntus-145
- Status last verified
- Aug 2008
- First submitted
- 8 Nov 2007
- Last updated
- 6 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17960408
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT00555776
- Acronym / sponsor ID
- Gaba-tinntus-145
- Conditions
- Subjective Tinnitus
- Keywords
- tinnitus, gabapentin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Islamic Azad University of MashhadUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GabapentinRandomly,half of the subjects are given Gabapentin. |
| 2 | Placebo comparator | Drug: placeboRandomly,half of the subjects receive placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with subjective idiopathic tinnitus
Key exclusion criteria (3 listed)
- tinnitus with known underlying cause
- pregnant women and patients younger than 18 or older than 75 years
- patients with impaired renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: NeurontineGabapentin, 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. | Drug | 1 |
| placeboplacebo is given with the same definition as Gabapentin | Drug | 2 |
Primary outcome
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
1 secondary outcome
Relieve of complications of tinnitus, such as sleep difficulties.
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2009.
- Results publication: PubMed 17960408Bakhshaee 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.
Related trials for Subjective Tinnitus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahboobeh Adami Dehkordi, MD principal investigator
ENT department of Mashhad azad university of mashhad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin in people with Subjective Tinnitus, run by Islamic Azad University of Mashhad at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2009.