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A Study on the Effect of Cilostazol in Patients With Chronic Tinnitus (CITI-ESR)

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ClinicalTrials.gov Identifier: NCT01378650
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Jong Woo Chung, Asan Medical Center

June 21, 2011
June 22, 2011
May 22, 2014
July 2011
June 2013   (Final data collection date for primary outcome measure)
Change of the tinnitus handicap inventory (THI) score [ Time Frame: within 2 weeks before administration, 2 weeks after administration, 4 week after administration ]
A Questionnaire for assessing subjective discomfort from chronic tinnitus
  • Change of the tinnitus handicap inventory (THI) score [ Time Frame: pre-administration, 2 weeks after administration, 4 week after administration ]
    A Questionnaire for assessing subjective discomfort from chronic tinnitus
  • Change of the visual analogue scale (VAS) score [ Time Frame: pre-administration, 2 weeks after administration, 4 week after administration ]
    A Questionnaire for assessing subjective discomfort from chronic tinnitus
  • Change of Quality of life (SF-36) score [ Time Frame: pre-administration, 2 weeks after administration, 4 week after administration ]
    A questionnaire for assessing subjective discomfort from chronic tinnitus
Complete list of historical versions of study NCT01378650 on ClinicalTrials.gov Archive Site
  • Changes of Quality of Life (SF-36) score [ Time Frame: within 2weeks before administration, 2 weeks after administration, 4 weeks after administration ]
    A questionnaire for assessing subjective discomfort from chronic tinnitus
  • Change of the visual analogue scale (VAS) score [ Time Frame: within 2 weeks before administration, 2 weeks after administration, 4 week after administration ]
    A Questionnaire for assessing subjective discomfort from chronic tinnitus
Not Provided
Not Provided
Not Provided
 
A Study on the Effect of Cilostazol in Patients With Chronic Tinnitus
A Randomized, Prospective, Placebo-controlled Double-blind, Pilot Study on the Effect of Cilostazol for 4 Weeks in Patients With Chronic Tinnitus
  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 oxide(NO) is a well-known neurotransmitter acting as a vasodilator through regulation of production of cyclic guanosine monophosphate(cGMP) 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 monophosphate(cAMP). 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.
  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 K12.0 (paired t-test for changes of each group and Mann-Whitney U test for comparing the mean scores of two groups)
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Tinnitus
  • Drug: Cilostazol
    Administration of Cilostazol 100mg twice a day for 4 weeks
    Other Name: Pletaal
  • Drug: Placebo
    placebo one tablet matching for cilostazol twice a day for 4 weeks.
    Other Name: Placebo matching for cilostazol
  • Experimental: Cilostazol group
    Administration of Cilostazol 100mg twice a day for 4 weeks
    Intervention: Drug: Cilostazol
  • Placebo Comparator: Placebo group
    placebo drug twice a day for 4 weeks.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults of age over 19
  • Unilateral or bilateral tinnitus
  • Chronic tinnitus lasting more than 3 months
  • Initial visual analogue scale of tinnitus >3

Exclusion Criteria:

  • Conductive hearing loss on pure tone audiometry
  • Associated other inner ear diseases such as Meniere's disease
  • Objective or pulsatile tinnitus
  • Contraindication to anti-platelet drug
  • Any cardiac disease
  • Bleeding tendency and major operation within 3 months
  • Breastfeeding
  • Pregnancy
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01378650
AMC-2010-0800
KCT0000128 ( Registry Identifier: Clinical Research Information Service (CRIS) )
No
Not Provided
Not Provided
Jong Woo Chung, Asan Medical Center
Jong Woo Chung
Korea Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Jong Woo Chung, M.D. Asan Medical Center
Asan Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP