NCT03664674已完成3 期
A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single 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
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 65
- 主要终点
- 28-Day Average DVD at Week 12 (Month 3)
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
- •Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
- •Subject has experienced active vertigo during the lead-in period.
- •Subject has documented asymmetric sensorineural hearing loss.
- •Subject agrees to maintain their current treatments for Meniere's disease while on-study.
排除标准
- •Subject is pregnant or lactating.
- •Subject has a history of immunodeficiency disease.
- •Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
- •Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- •Subject has a history of vestibular migraine.
- •Subject has used an investigational drug or device in the 3 months prior to screening.
- •Subject has previously been randomized to a clinical study of OTO-104.
研究组 & 干预措施
OTO-104
Experimental
干预措施: OTO-104 (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
28-Day Average DVD at Week 12 (Month 3)
时间窗: 3 months
The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28.
次要结局
- Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden(3 Months)
- Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit(3 months)
- Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3)(Week 12 (Month 3))
- Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)(Week 12 (Month 3))
- Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)(Week 12 (Month 3))
研究者
研究点 (65)
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