NCT01583738已完成2 期
Effect of V0251 in Acute Vertigo
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 39
- 主要终点
- "Vertigo Symptoms Score" (VSS) rated by patient using VAS
研究概览
简要总结
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women
- •Age 18 to 70 years
- •Acute vertigo attack due to vestibular disorder
排除标准
- •Signs of brain, brainstem and/or cerebellar dysfunction
- •Concomitant central neurological disorder
- •Psychogenic vertigo
- •Use of ototoxic drugs causing vertigo or dizziness within the last month
- •Use of anti-dizziness medications from the onset of symptoms, except if the dosage had been stable for at least 3 months
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
V0251
Experimental
干预措施: V0251 (Drug)
结局指标
主要结局
"Vertigo Symptoms Score" (VSS) rated by patient using VAS
时间窗: 30 min
次要结局
- Number of patients with Adverse Events as a measure of safety and tolerability(30 min, 2 hours and 4 hours post dose)
- "Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS(30 min, 2 hours and 4 hours post dose)
研究者
研究点 (39)
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