Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy (REREV)
Primary Purpose
Recurrent Vestibulopathy
Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Vestibulopathy focused on measuring Renexin for Recurrent Vestibulopathy
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Renexin
Placebo
Arm Description
Renexin 1T bid for 12 weeks
Placebo 1T bid for 12 weeks
Outcomes
Primary Outcome Measures
equilibrium score of dynamic posturography
compared with pretreatment equilibrium score
Secondary Outcome Measures
dizziness handicap inventory
compared with pretreatment DHI score
visual analogue scale (VAS) of vertigo
compared with pretreatment VAS score
Questionnaire for Quality of life (SF36)
compared with pretreatment SF36 score
Full Information
NCT ID
NCT01895400
First Posted
July 5, 2013
Last Updated
February 14, 2016
Sponsor
Jong Woo Chung
Collaborators
SK Chemicals Co., Ltd., Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01895400
Brief Title
Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
Acronym
REREV
Official Title
A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Participant enrollment is much delayed. The whole design needs to be revised.
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jong Woo Chung
Collaborators
SK Chemicals Co., Ltd., Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Vestibulopathy
Keywords
Renexin for Recurrent Vestibulopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renexin
Arm Type
Active Comparator
Arm Description
Renexin 1T bid for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1T bid for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
Other Intervention Name(s)
Renexin
Intervention Description
Take Renexin 1T bid po medication for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Renexin
Intervention Description
Take placebo drug 1T bid po medication for 8 weeks
Primary Outcome Measure Information:
Title
equilibrium score of dynamic posturography
Description
compared with pretreatment equilibrium score
Time Frame
after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
dizziness handicap inventory
Description
compared with pretreatment DHI score
Time Frame
at 4 weeks, 8 weeks after treatment
Title
visual analogue scale (VAS) of vertigo
Description
compared with pretreatment VAS score
Time Frame
at 4 weeks, 8 weeks after treatment
Title
Questionnaire for Quality of life (SF36)
Description
compared with pretreatment SF36 score
Time Frame
at 4 weeks, 8 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Woo Chung, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
This study is decided to be terminated. Among 26 participants, 15 finished medication according to the protocol. I am not sure that these data can be analyzed because data is still unblinded.
Learn more about this trial
Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
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