NCT00578773已完成2 期
Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea
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
- 303
- 主要终点
- Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
研究概览
简要总结
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
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
- Single (Participant)
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
- •6 months to 12 years old
- •Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
- •Must be first set of ear tubes.
- •Patient may not have had any other previous otologic-related surgery.
- •Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
- •Patient may not have existing perforation of the eardrum.
- •Patient must not require another surgical procedure other than myringotomy and tube insertion.
- •Patient may not be a menarchal female
- •Diabetic patients are not eligible
- •Patient may not have any disease or condition that would negatively affect the conduct of the study
- •Patient may not require any other systemic antimicrobial therapy during the study.
- •Patient must meet certain medication washouts to be eligible
- •Analgesic use (other than acetaminophen) is not allowed
- •Patient may not be pre-disposed to neurosensory hearing loss
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Moxidex
Experimental
Moxidex otic solution
干预措施: Moxidex otic solution (Drug)
Moxidex
Experimental
Moxidex otic solution
干预措施: Tympanostomy tubes (Device)
Moxifloxacin
Active Comparator
Moxifloxacin otic solution
干预措施: Moxifloxacin otic solution (Drug)
Moxifloxacin
Active Comparator
Moxifloxacin otic solution
干预措施: Tympanostomy tubes (Device)
TT only
Other
Tympanostomy tubes only
干预措施: Tympanostomy tubes (Device)
结局指标
主要结局
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
时间窗: From baseline
次要结局
- Clinical cures at each visit(From baseline)
- Absence of otorrhea at each visit(From baseline)
研究者
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