A Study on the Effect of Cilostazol in Patients With Chronic Tinnitus

NCT01378650 | Completed

• 2 other identifiers: AMC-2010-0800KCT0000128
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Tinnitus

Keywords

Tinnitus; Medication therapy management; Cilostazol; Antiplatelet agents

Outcome Measures

Primary Outcomes (1)

• Change of the tinnitus handicap inventory (THI) score

  A Questionnaire for assessing subjective discomfort from chronic tinnitus

  within 2 weeks before administration, 2 weeks after administration, 4 week after administration

Secondary Outcomes (2)

• Changes of Quality of Life (SF-36) score

  within 2weeks before administration, 2 weeks after administration, 4 weeks after administration

• Change of the visual analogue scale (VAS) score

  within 2 weeks before administration, 2 weeks after administration, 4 week after administration

Study Arms (2)

Cilostazol group

EXPERIMENTAL

Administration of Cilostazol 100mg twice a day for 4 weeks

Drug: Cilostazol

Placebo group

PLACEBO COMPARATOR

placebo drug twice a day for 4 weeks.

Drug: Placebo

Interventions

Cilostazol DRUG

Administration of Cilostazol 100mg twice a day for 4 weeks

Also known as: Pletaal

Cilostazol group

Placebo DRUG

placebo one tablet matching for cilostazol twice a day for 4 weeks.

Also known as: Placebo matching for cilostazol

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jong Woo Chung: lead
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (2)

• Mazurek B, Haupt H, Szczepek AJ, Sandmann J, Gross J, Klapp BF, Kiesewetter H, Kalus U, Stover T, Caffier PP. Evaluation of vardenafil for the treatment of subjective tinnitus: a controlled pilot study. J Negat Results Biomed. 2009 Feb 17;8:3. doi: 10.1186/1477-5751-8-3.

  PMID: 19222841 BACKGROUND

• Ye YL, Shi WZ, Zhang WP, Wang ML, Zhou Y, Fang SH, Liu LY, Zhang Q, Yu YP, Wei EQ. Cilostazol, a phosphodiesterase 3 inhibitor, protects mice against acute and late ischemic brain injuries. Eur J Pharmacol. 2007 Feb 14;557(1):23-31. doi: 10.1016/j.ejphar.2006.11.003. Epub 2006 Nov 10.

  PMID: 17161838 BACKGROUND

Related Links

• Clinical Research Information Service (CRIS)
• Institutional Review Board of Asan Medical Center

MeSH Terms

Conditions

Tinnitus

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jong Woo Chung, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 22, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

KR (1)