Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01378650
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2011-06-21
Brief Title:
A Study on the Effect of Cilostazol in Patients With Chronic Tinnitus
Sponsor:
Jong Woo Chung
Organization:
Asan Medical Center
Study Overview
Official Title:
A Randomized Prospective Placebo-controlled Double-blind Pilot Study on the Effect of Cilostazol for 4 Weeks in Patients With Chronic Tinnitus
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CITI-ESR
Brief Summary:
1 Overview of tinnitus Tinnitus is a noisy sound which is perceived without any external sound source According to the survey of the US 10-20 of adult have the symptom of tinnitus and 3-5 of tinnitus patients have severe discomfort of daily life Severe tinnitus can result in psychiatric problems such as depression and anxiety disorders Enhancement of environmental sound hearing aids sound generators cognitive therapy transcranial magnetic therapy and drug therapy have been tried for treatment of tinnitus Nitric oxideNO is a well-known neurotransmitter acting as a vasodilator through regulation of production of cyclic guanosine monophosphatecGMP and can be found in various sites of cochlea It is reported that cGMP enhances activity of protein kinase A PKA a mediator of platelet aggregation inhibition and vasodilatation and results in increase of vascular flow
2 Characteristics of the clinical research drug cilostazol Cilostazol inhibits phosphodiesterase type 3 PDE3 selectively and increases amount of cAMP by inhibition of degradation of cyclic adenosine monophosphatecAMP cAMP again by increasing the active form of PKA suppress the production of blood clots and increase blood flow by expanding blood vessels Anti-platelet activity and vasodilatation effect of cilostazol have been used for improvement of diabetic peripheral vascular disorders and suppression of stroke recurrence Previous studies reported that by increasing the activity of NO and PKA the blood flow of stria vascularis and cochlear hair cells can be improved These studies implies that cilostazol which causes inhibition of PDE3 and increase of PKA can have a potential effect on improvement of tinnitus by increase of blood flow to peripheral cochlear cells Thus we hypothesized that cilostazol which has been widely used for enhancing peripheral blood flow can bring improvement of tinnitus by causing better peripheral blood flow of cochlea
3 The aim of the study We planned this study to validate the assumptions of the background The aim of our study is whether administration of cilostazol can improve tinnitus in terms of subjective degree of symptoms in chronic tinnitus patients
2 Characteristics of the clinical research drug cilostazol Cilostazol inhibits phosphodiesterase type 3 PDE3 selectively and increases amount of cAMP by inhibition of degradation of cyclic adenosine monophosphatecAMP cAMP again by increasing the active form of PKA suppress the production of blood clots and increase blood flow by expanding blood vessels Anti-platelet activity and vasodilatation effect of cilostazol have been used for improvement of diabetic peripheral vascular disorders and suppression of stroke recurrence Previous studies reported that by increasing the activity of NO and PKA the blood flow of stria vascularis and cochlear hair cells can be improved These studies implies that cilostazol which causes inhibition of PDE3 and increase of PKA can have a potential effect on improvement of tinnitus by increase of blood flow to peripheral cochlear cells Thus we hypothesized that cilostazol which has been widely used for enhancing peripheral blood flow can bring improvement of tinnitus by causing better peripheral blood flow of cochlea
3 The aim of the study We planned this study to validate the assumptions of the background The aim of our study is whether administration of cilostazol can improve tinnitus in terms of subjective degree of symptoms in chronic tinnitus patients
Detailed Description:
1 Clinical research methods
Determination of eligibility by history taking physical examination pure tone audiometry speech audiometry and distortion product otoacoustic emission test
Randomization by random sequence generation
Administration cilostazol 100mg Bid 4 weeks for the study group and placebo tablet Bid 4 weeks for the control group
Evaluation battery questionnaires tinnitus handicap inventory visual analogue scale Quality of life SF-36
Time of evaluation pre-administration 2 weeks after administration 4 week after administration
Monitoring of side effects
2 Evaluation of treatment response - Statistical analysis of scores of questionnaires using SPSS K120 paired t-test for changes of each group and Mann-Whitney U test for comparing the mean scores of two groups
Determination of eligibility by history taking physical examination pure tone audiometry speech audiometry and distortion product otoacoustic emission test
Randomization by random sequence generation
Administration cilostazol 100mg Bid 4 weeks for the study group and placebo tablet Bid 4 weeks for the control group
Evaluation battery questionnaires tinnitus handicap inventory visual analogue scale Quality of life SF-36
Time of evaluation pre-administration 2 weeks after administration 4 week after administration
Monitoring of side effects
2 Evaluation of treatment response - Statistical analysis of scores of questionnaires using SPSS K120 paired t-test for changes of each group and Mann-Whitney U test for comparing the mean scores of two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KCT0000128 | REGISTRY | Clinical Research Information Service CRIS | None |