Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Cure (reduced pain, swelling and otorrhea)
研究概览
简要总结
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.
详细描述
Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.
Population: 224 patients with external otitis , men and women aged between 1 - 70 years.
Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).
Secondary endpoint: The endpoint will be the identification of the side effects of medication use.
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
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed of the nature of the study and given written informed consent;
- •Patients with acute otitis externa;
- •Intact tympanic membrane.
排除标准
- •Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone;
- •Patient has the tympanic membrane not intact;
- •Bilateral Acute Otitis Externa;
- •Pregnant or lactating patients;
- •Overt fungal Acute Otitis Externa;
- •Other diseases of the ear
- •Current Infection requiring systemic antimicrobial therapy.
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
研究组 & 干预措施
Cipro HC
Reference product
干预措施: Cipro HC (Drug)
Ciprofloxacin HCl and Hydrocortisone
Test product
干预措施: Ciprofloxacin HCl and Hydrocortisone (Drug)
结局指标
主要结局
Cure (reduced pain, swelling and otorrhea)
时间窗: 7 days
次要结局
- Identification of possible side effects(7 days)