NCT00750633已完成3 期
A Phase III Study of an Otic Formulation in Acute Otitis Externa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 990
- 主要终点
- Clinical Cure
研究概览
简要总结
The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
- •A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
- •Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
- •Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
- •Known or suspected ear infection of fungal or mycobacterial origin
- •Prior otologic surgery within 6 months of study entry
- •Seborrheic dermatitis or other skin conditions of the external auditory canal
- •Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
- •Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
- •Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study [e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction]
- •Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
- •Use of prohibited medications or inadequate washout of any medication listed in protocol
- •Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Moxidex
Experimental
Moxidex otic solution
干预措施: Moxidex otic solution (Drug)
Moxidex
Experimental
Moxidex otic solution
干预措施: Tympanostomy tubes (Device)
Moxifloxacin
Active Comparator
Moxifloxacin otic solution
干预措施: Moxifloxacin otic solution (Drug)
Moxifloxacin
Active Comparator
Moxifloxacin otic solution
干预措施: Tympanostomy tubes (Device)
Dexamethasone
Active Comparator
Dexamethasone phosphate otic solution
干预措施: Dexamethasone phosphate otic solution (Drug)
Dexamethasone
Active Comparator
Dexamethasone phosphate otic solution
干预措施: Tympanostomy tubes (Device)
结局指标
主要结局
Clinical Cure
时间窗: Day 12
次要结局
- Microbiological Success(Day 12)
研究者
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