NCT02600559已完成3 期
An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
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
- 501
- 试验地点
- 1
- 主要终点
- Number of Subjects With Post-surgical Otorrhea
研究概览
简要总结
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 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
0.1 mL OTO-201
Experimental
Ciprofloxacin
干预措施: OTO-201 (ciprofloxacin) (Drug)
结局指标
主要结局
Number of Subjects With Post-surgical Otorrhea
时间窗: 8 weeks
Absence or presence of otorrhea (drainage from the middle ear)
次要结局
- Adverse Events(Up to Eight Weeks)
- Caregiver Burden - Ear Drops Administration(Week 8)
- Caregiver Burden - Ear Discharge Control(Week 8)
研究者
研究点 (1)
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