NCT00579189已完成3 期
Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
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
- 776
- 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 a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •6 months to 12 years old
- •Ear tubes in one or both ears
- •Ear drainage visible by the parent / guardian
- •Ear drainage less than 21 days
- •Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
- •Patient may not have non-tube otorrhea
- •Patient may not have had otic surgery other than tube placement in the last year
- •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)
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 cure rate(From baseline)
- Microbiological outcome(From baseline)
- Treatment failures(From baseline)
研究者
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