NCT01412177已完成2 期
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b 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
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
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 80 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.
- •Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.
排除标准
- •Subject is pregnant or lactating.
- •Subject has a history of immunodeficiency disease.
- •Subject has a history of previous endolymphatic sac surgery.
- •Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
- •Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- •Subject has experienced an adverse reaction to IT injection of steroids.
- •Subject has used an investigational drug or device in the 3 months prior to screening.
- •Subject has previously been randomized to a trial 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
Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
时间窗: 4 months
次要结局
- Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability(4 months)
- Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living(4 months)
- Evaluation of patient reported questionnaires as a measure of impact on patient daily activities(4 months)
研究者
研究点 (2)
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