NCT02257983已完成2 期
A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
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
- 77
- 试验地点
- 1
- 主要终点
- Pure tone audiometry
研究概览
简要总结
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults ages 18-30
- •Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30 days prior to treatment initiation
- •Non-smokers
- •Abstention from alcohol from day 0 and throughout the duration of study
- •Normal audiology exam
- •Subject must be able to swallow size 0 capsules
排除标准
- •Allergy to EPI-743 or sesame oil or nuts
- •Any medical disordere that would prevent subject participation
- •Any prescription meds other than for contraception or seasonal allergies
- •Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, ADHD, hx. of migraines, neurological, kidney)
- •Fat malabsorption syndromes
- •Anticoagulation thereapy within 30 days of enrollment
研究组 & 干预措施
EPI-743
Active Comparator
EPI-743 400 mg P.O. TID
干预措施: EPI-743 (Drug)
Placebo
Placebo Comparator
Sesame Oil, NF in sealed gelatin capsules to match the test product
干预措施: Placebo (Drug)
结局指标
主要结局
Pure tone audiometry
时间窗: 9 days
次要结局
- Time to recovery following acute noise exposure(9 days)
研究者
研究点 (1)
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