NCT02740387终止2 期
A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Evaluation of adverse events as a measure of safety and tolerability
研究概览
简要总结
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OTO-104
Experimental
12 mg dexamethasone
干预措施: OTO-104 (Drug)
结局指标
主要结局
Evaluation of adverse events as a measure of safety and tolerability
时间窗: Up to 1 Year
次要结局
- Change in hearing from baseline as assessed by audiometry(Up to 1 Year)
- Changes in patient condition assessed by otoscopy(Up to 1 Year)
- Changes in patient condition assessed by tympanometry(Up to 1 Year)
研究者
研究点 (1)
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