Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01895400
Other study ID # AMC-2013-0165
Secondary ID 20130055275
Status Terminated
Phase Phase 3
First received July 5, 2013
Last updated February 14, 2016
Start date July 2013
Est. completion date December 2015

Study information

Verified date February 2016
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.


Description:

1. Study design

- Among patients who visitied for recurrent vertigo more than 3 months, patients will be included after ruling out other peripheral vertigo through history taking, physical examination, Dix-Hallpike test, head-thrust test.

- Included patients will go through permission, laboratory tests (CBC, chemical battery, coagulation battery, urine HCG (only women of childbearing age), posturography. During patients selection period for inclusion(2 weeks), taking medication for vertigo is prohibited.

- Included patients will be randomized to Treatment group (Renexin) and Placebo group.

- All patients before treatment will do dizziness handicap inventory(DHI), visual analogue scale (VAS) for vertigo, questionnaire for quality of life (SF36).

- After 4 weeks(+-~ 3 days) of drug administration, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects.

- After 8 weeks(+-~ 3 days) of drug administration, posturography, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects.

- For control of severe vertigo during drug administration, Valium 2mg can be used as a salvage treatment, and number of valium administration will be checked at every visit.

2. Statistical analysis

- As a statistical analysis, paired T-test will be used to compare equilibrium score, DHI, VAS, SF-36. When p-value is <0.05, it will be considered as significant difference.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo

- Visual analogue scale (VAS) score between 4 to 8

Exclusion Criteria:

- Showing signs of central lesion in MRI or neurologic exams

- central nystagmus or loss of consciousness with vertigo

- cerebellar symptoms such as ataxia, dysarthria, gait disturbance

- Diagnosed as peripheral vertigo such as benign paroxysmal positional vertigo, Meniere's disease, migrainous vertigo in recent 3 months

- Bilateral vestibular dysfunction

- Vestibular neuronitis symptom appeared in recent 6 months

- Chronic liver disease (ALT>100 or AST>100) or chronic kidney disease (Creatinine > 3.0 mg)

- Blood Hemoglobin < 10mg/dl (in male) or < 8 mg/dl (in female)

- Contraindication for testing drug (ex. Pregnancy or breast feeding etc.)

- Taking antiepileptics such as phenobarbital, phenytoin, carbamazepine or rifampin in recent 2 weeks

- Taking cilostazol, gingko biloba for other disease

- Allergy/hypersensitivity to Renexin

- Severe drug toxicity when taking Renexin previously

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
Take Renexin 1T bid po medication for 8 weeks
Placebo
Take placebo drug 1T bid po medication for 8 weeks

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (3)

Lead Sponsor Collaborator
Jong Woo Chung Asan Medical Center, SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary equilibrium score of dynamic posturography compared with pretreatment equilibrium score after 8 weeks of treatment No
Secondary dizziness handicap inventory compared with pretreatment DHI score at 4 weeks, 8 weeks after treatment No
Secondary visual analogue scale (VAS) of vertigo compared with pretreatment VAS score at 4 weeks, 8 weeks after treatment No
Secondary Questionnaire for Quality of life (SF36) compared with pretreatment SF36 score at 4 weeks, 8 weeks after treatment Yes
See also
  Status Clinical Trial Phase
Suspended NCT04026516 - CAVA: Dizziness Trial N/A