A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 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
12 mg dexamethasone
干预措施: OTO-104 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population
时间窗: 3 months
The number of DVDs at Week 12 (the 4-week \[28 days\] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population
时间窗: 3 months
In the Full Analysis Set (FAS)-1 population, the number of DVDs at Week 12 (the 4-week \[28 days\] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
次要结局
- Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)(3 months)
- Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1(3 months)
- Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)(3 months)
- Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2(3 months)
- Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)(3 months)
- Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)(3 Months)