NCT01755286已完成1 期
A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 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
Vehicle for OTO-201
Placebo Comparator
干预措施: Placebo (Drug)
Sham
Sham Comparator
干预措施: Sham (Drug)
4 mg OTO-201
Experimental
干预措施: OTO-201 (Drug)
12 mg OTO-201
Experimental
干预措施: OTO-201 (Drug)
结局指标
主要结局
Safety
时间窗: Up to 1 month
Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
次要结局
- Clinical Activity(Up to 1 month)
- Microbiological Eradication(Up to 1 month)
研究者
研究点 (1)
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