A Phase III, Multicenter, Randomized, Double-blind, Parallel Group, Active Treatment-controlled Study Assessing the Safety and Efficacy of G238 Compared to Clotrimazole 1% Otic Solution in Patients With Otomycosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Proportion of Subjects With a Complete Response to Treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •Clinical diagnosis of otomycosis where topical treatment is indicated.
排除标准
- •Other ear diseases.
研究组 & 干预措施
G238
Five drops into the ear canal twice daily for 14 days
干预措施: G238 (Drug)
Clotrimazole
Five drops into the ear canal twice daily for 14 days
干预措施: Clotrimazole (Drug)
结局指标
主要结局
Proportion of Subjects With a Complete Response to Treatment
时间窗: Day 24
Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24. Response to the study treatment was classed according to the following definitions: * Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24. * Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24. * No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms \> 2 on day 24.
次要结局
- Changes in Signs/ Symptoms(2 weeks and 4 weeks)