NCT01071902终止3 期
Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical Cure at End of Treatment
研究概览
简要总结
The purpose of this study is to determine if Moxidex otic solution 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
- Triple (Participant, Care Provider, Investigator)
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 of age
- •Ear tubes in one or both ears
- •Ear drainage visible by parent/guardian
- •Ear drainage less than 21 days
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
- •Ear tube with antimicrobial activity; ear tube longer than 2.5mm
- •Non-tube otorrhea
- •No otic surgery other than tube placement in the last year
- •No menarchial females; no diabetic patients
- •No patients with any disease or condition that would negatively affect the conduct of the study
- •No patients taking 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
- •Patients may not be predisposed to neurosensory hearing loss
- •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)
Vehicle
Placebo Comparator
Vehicle
干预措施: Vehicle (Other)
Vehicle
Placebo Comparator
Vehicle
干预措施: Tympanostomy tubes (Device)
结局指标
主要结局
Clinical Cure at End of Treatment
时间窗: Day 8
次要结局
- Time to Cessation of Otorrhea(From First Dose)
- Microbiological Success at End of Treatment(Day 8)
研究者
研究点 (1)
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Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes - Safety and Efficacy of Moxidex Otic Solution in AOMTEUCTR2009-017319-13-BEAlcon Research Ltd.1,300
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Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes - Safety and Efficacy of Moxidex Otic Solution in AOMTAcute otitis media with otorrhea in tympanostomy tubesMedDRA version: 12.1Level: LLTClassification code 10033079Term: Otitis media acuteEUCTR2009-017319-13-FIAlcon Research Ltd.1,300
进行中（未招募）
不适用
Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes - Safety and Efficacy of Moxidex Otic Solution in AOMTEUCTR2009-017319-13-DKAlcon Research Ltd.1,300
进行中（未招募）
1 期
Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes - Safety and Efficacy of Moxidex Otic Solution in AOMTAcute otitis media with otorrhea in tympanostomy tubesMedDRA version: 12.1Level: LLTClassification code 10033079Term: Otitis media acuteEUCTR2009-017319-13-FRAlcon Research Ltd.1,300