NCT00781521已完成3 期
A Pilot, Multicenter, Open Label, Non Comparative Study of the Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children With Tympanostomy Tubes
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
- 96
- 主要终点
- Sponsor determined clinical cure of otitis media
研究概览
简要总结
This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female
- •6 months of age to <12 years of age
- •weight = or >4.5 kg
- •Patent tympanostomy tube(s) in the affected ear(s)
- •Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin
排除标准
- •Non-bacterial otic infection
- •Known or suspected hypersensitivity to ofloxacin
- •Cystic fibrosis
- •HIV infection
- •Neutropenia
- •Receiving immunosuppressive therapy
研究组 & 干预措施
1
Experimental
Floxin otic solution twice a day for 7 days
干预措施: ofloxacin otic solution 0.3% (Drug)
结局指标
主要结局
Sponsor determined clinical cure of otitis media
时间窗: 7 days
Sponsor determined microbiological cure of otitis media
时间窗: 7 days
次要结局
- Investigator determined clinical cure(7 days)
- Overall per-subject microbiological outcome(7 days)
- Overall per pathogen microbiological outcome(7 days)
- sign and symptoms of otitis media(7 days)
研究者
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