A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.
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 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Drug: OP0201 + Antibiotics
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
干预措施: OP0201 (Combination Product)
Drug: OP0201 + Antibiotics
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
干预措施: Amoxicillin-clavulanate (Drug)
Placebo Comparator: Placebo +Antibiotics
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
干预措施: Placebo (Combination Product)
Placebo Comparator: Placebo +Antibiotics
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
干预措施: Amoxicillin-clavulanate (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Days 1-28
Evaluation of Efficacy (Otoscopy)
时间窗: Day 12
Percentage of study participants with no middle ear effusion
次要结局
未报告次要终点