NCT00523120终止2 期
Topical Voltaren as an Alternative Treatment for Otitis Externa
Sieff Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- reducing oral analagestic use
研究概览
简要总结
Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.
详细描述
anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults having otitis externa as single diagnosis mild to moderate
排除标准
- •Pregnant women
- •Immune compromise
- •Starting other treatment
- •Moderate to severe otitis externa
研究组 & 干预措施
1
Active Comparator
voltaren ophta
干预措施: diclofenac sodium (Drug)
2
Active Comparator
dexotic
干预措施: dexotc (Drug)
结局指标
主要结局
reducing oral analagestic use
时间窗: 1 week
次要结局
- adding an alternative treatment for otitis externa(1 week)
研究者
victor kizhner
Victor Kizhner MD
Sieff Medical Center
研究点 (1)
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