NCT00393835已完成3 期
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin Sustained Release (SR) For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis In Japan Adults
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 99
- 试验地点
- 6
- 主要终点
- The primary endpoint is Investigator's Clinical efficacy at Day 8.
研究概览
简要总结
To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
排除标准
- •Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
结局指标
主要结局
The primary endpoint is Investigator's Clinical efficacy at Day 8.
次要结局
- Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data
研究者
研究点 (6)
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