A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 46
- 主要终点
- Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
研究概览
简要总结
The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day).
- •Subject is able to use the diary to complete their daily tinnitus ratings.
- •Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure.
- •Subject is willing to comply with the protocol and attend all study visits.
排除标准
- •Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
- •Subject is pregnant, lactating, or undergoing fertility treatment.
- •Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
研究组 & 干预措施
OTO-313
干预措施: OTO-313 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
时间窗: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus. A responder is considered as any subject with at least a 13-point improvement from Baseline on the (TFI). This responder analysis required both Week 4 and Week 8 to have a 13-point improvement from Baseline.
次要结局
- Change From Baseline in Daily Tinnitus Loudness at Week 8(The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.)
- Change From Baseline in Daily Tinnitus Annoyance at Week 8(The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8)
- Patient Global Impression of Change at Week 8(Week 8 reported here)