Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 84
- 主要终点
- Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
研究概览
简要总结
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.
详细描述
The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.
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
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
- •Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
- •Presence of patent tympanostomy tubes;
- •Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
- •Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
- •Menarcheal females;
- •Previous otologic surgery, except tympanic membrane, within one year of study entry;
- •History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
- •Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
- •Diabetic (controlled or uncontrolled);
- •Use of prohibited medications;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-60371/AL-817
AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
干预措施: AL-60371/AL-817 otic suspension (Drug)
CIPRODEX
Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days
干预措施: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension (Drug)
结局指标
主要结局
Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
时间窗: Day 3 post-treatment up to Day 8 or Early Exit
A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.
次要结局
- Proportion of Subjects With Microbiological Success at the Day 8 Visit(Day 8)
- Median Time (in Days) to Cessation of Otorrhea(Time to event, up to Day 8)