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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

Tracking Information
First Submitted Date  ICMJE June 21, 2011
First Posted Date  ICMJE June 22, 2011
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE July 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
  • 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
Change History Complete list of historical versions of study NCT01378650 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Effect of Cilostazol in Patients With Chronic Tinnitus
Official Title  ICMJE A Randomized, Prospective, Placebo-controlled Double-blind, Pilot Study on the Effect of Cilostazol for 4 Weeks in Patients With Chronic Tinnitus
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 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.
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 K12.0 (paired t-test for changes of each group and Mann-Whitney U test for comparing the mean scores of two groups)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01378650
Other Study ID Numbers  ICMJE AMC-2010-0800
KCT0000128 ( Registry Identifier: Clinical Research Information Service (CRIS) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jong Woo Chung, Asan Medical Center
Study Sponsor  ICMJE Jong Woo Chung
Collaborators  ICMJE Korea Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Jong Woo Chung, M.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date May 2014

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