NCT01404611已完成3 期
A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients
Salvat1 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- Time to Cessation of Otorrhea
研究概览
简要总结
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children 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
- •ear tube in the ear which will be treated
- •otorrhea for 3 weeks or less
- •moderate or severe otorrhea
排除标准
- •other ear diseases
研究组 & 干预措施
DF289
Active Comparator
Ear drops
干预措施: DF289 (Drug)
DF277
Active Comparator
Ear drops
干预措施: DF277 (Drug)
DF289 plus DF277
Experimental
Ear drops
干预措施: DF289 plus DF277 (Drug)
结局指标
主要结局
Time to Cessation of Otorrhea
时间窗: From baseline until the end of the study (up to 22 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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