Status:
TERMINATED
Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
Lead Sponsor:
Jong Woo Chung
Collaborating Sponsors:
SK Chemicals Co., Ltd.
Asan Medical Center
Conditions:
Recurrent Vestibulopathy
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.
Detailed 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 examina...
Eligibility Criteria
Inclusion
- Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo
- Visual analogue scale (VAS) score between 4 to 8
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01895400
Start Date
July 1 2013
End Date
December 1 2015
Last Update
February 17 2016
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736