NCT01895400终止3 期
A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
Jong Woo Chung1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- equilibrium score of dynamic posturography
研究概览
简要总结
The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo
- •Visual analogue scale (VAS) score between 4 to 8
排除标准
- •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
研究组 & 干预措施
Renexin
Active Comparator
Renexin 1T bid for 12 weeks
干预措施: Renexin (cilostazol 100mg + gingko biloba extract 80 mg) (Drug)
Placebo
Placebo Comparator
Placebo 1T bid for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
equilibrium score of dynamic posturography
时间窗: after 8 weeks of treatment
compared with pretreatment equilibrium score
次要结局
- visual analogue scale (VAS) of vertigo(at 4 weeks, 8 weeks after treatment)
- dizziness handicap inventory(at 4 weeks, 8 weeks after treatment)
- Questionnaire for Quality of life (SF36)(at 4 weeks, 8 weeks after treatment)
研究者
Jong Woo Chung
MD
Asan Medical Center
研究点 (1)
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