NCT00578474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
- 911
- 主要终点
- Clinical cure rate at the test of cure visit as determined by the investigator
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 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
- •Age related
- •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)
FLOXIN
Active Comparator
Ofloxacin otic solution
干预措施: Ofloxacin otic solution (Drug)
FLOXIN
Active Comparator
Ofloxacin otic solution
干预措施: Tympanostomy tubes (Device)
结局指标
主要结局
Clinical cure rate at the test of cure visit as determined by the investigator
时间窗: From baseline
次要结局
- Microbiological outcome(From baseline)
- Treatment failures(From baseline)
- Time to cessation of otorrhea(From baseline)
研究者
相似试验
已完成
2 期
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube OtorrheaAcute Otitis MediaNCT00578773Alcon Research303
已完成
3 期
Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy TubesAcute Otitis MediaNCT00579189Alcon Research776
已完成
3 期
A Phase III Study of an Otic Formulation in Acute Otitis ExternaAcute Otitis ExternaNCT00750633Alcon Research990
终止
3 期
Safety and Efficacy of Moxidex OticAcute Otitis MediaNCT01071902Alcon Research400
已完成
2 期
Evaluation of a Vaccine for Reducing Ear and Lung Infections in ChildrenInfections, StreptococcalNCT01545375GlaxoSmithKline1,806