Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy (REREV)
|ClinicalTrials.gov Identifier: NCT01895400|
Recruitment Status : Terminated (Participant enrollment is much delayed. The whole design needs to be revised.)
First Posted : July 10, 2013
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Vestibulopathy||Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg) Drug: Placebo||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||July 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Renexin
Renexin 1T bid for 12 weeks
Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
Take Renexin 1T bid po medication for 8 weeks
Other Name: Renexin
Placebo Comparator: Placebo
Placebo 1T bid for 12 weeks
Take placebo drug 1T bid po medication for 8 weeks
Other Name: Renexin
- equilibrium score of dynamic posturography [ Time Frame: after 8 weeks of treatment ]compared with pretreatment equilibrium score
- dizziness handicap inventory [ Time Frame: at 4 weeks, 8 weeks after treatment ]compared with pretreatment DHI score
- visual analogue scale (VAS) of vertigo [ Time Frame: at 4 weeks, 8 weeks after treatment ]compared with pretreatment VAS score
- Questionnaire for Quality of life (SF36) [ Time Frame: at 4 weeks, 8 weeks after treatment ]compared with pretreatment SF36 score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895400
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Study Chair:||Jong Woo Chung, MD||Asan Medical Center|