NCT02592096Unknown1 期
A Single Dose Phase I Clinical Study of Pazufloxacin Mesilate Ear Drops for the Patients With Otitis Media
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- safety and tolerance of pazufloxacin mesilate ear drops
研究概览
简要总结
To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years old, both gender;
- •Patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents;
- •Written informed consent form.
排除标准
- •Allergic to quinolones antibiotics or severe allergic constitution;
- •Not able to collect otorrhea during the trial;
- •High severity with the need of combined antibiotics treatment;
- •Induced by pathogens, e.g.: fungus, virus (myringitis bullosa);
- •Combined otitis externa (e.g.: ear cellulitis, mumps), intracranial or extracranial complication (meningitis, cerebral abscess, thrombophlebitis of sigmoid sinus, Bezold's abscess, ear subperiosteal abscess);
- •Severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system;
- •Life-threatening disease, e.g.: malignant tumor or AIDS.
- •Renal hepatic dysfunction (ALT, AST ≥ 1.5 times of normal maximum level, Cr > normal maximum level);
- •Confirmed or suspected of alcohol/drug abuse record;
- •Neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction;
- •Feminine patients who are in gestational, lactation period or having a birth plan in short-term;
- •Enrolled into other clinical trial in the past 3 months;
- •Not suitable for this trial according to investigator's judgment;
研究组 & 干预措施
0.1% Pazufloxacin Mesilate Ear Drops
Experimental
10 drips for ear dropping, 10 minutes for ear bath
干预措施: 0.1% Pazufloxacin Mesilate Ear Drops (Drug)
0.3% Pazufloxacin Mesilate Ear Drops
Experimental
10 drips for ear dropping, 10 minutes for ear bath
干预措施: 0.3% Pazufloxacin Mesilate Ear Drops (Drug)
0.5% Pazufloxacin Mesilate Ear Drops
Experimental
10 drips for ear dropping, 10 minutes for ear bath
干预措施: 0.5% Pazufloxacin Mesilate Ear Drops (Drug)
Pazufloxacin mesilate injection
Active Comparator
0.3g, 30 minutes for ventricular injection
干预措施: Pazufloxacin mesilate injection (Drug)
结局指标
主要结局
safety and tolerance of pazufloxacin mesilate ear drops
时间窗: 24 hours
Any changes in vital signs; AE/SAE number
次要结局
- PK of pazufloxacin mesilate ear drops(24 hours)
研究者
研究点 (1)
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