NCT00945646终止3 期
A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal Otitis Externa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.
研究概览
简要总结
The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of AFOE of in one or both ears, based on a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1) and/or 1 for pruritis (absent = 0, present = 1)
- •Have appearance consistent with fungal debris, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp.
- •Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race
- •Provide written informed consent
- •Be willing and able to follow all instructions and attend all study visits
- •If female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at Visit 1 and upon their exit from the study. Post menopausal is defined as having no menses for 12 consecutive months.
排除标准
- •Have known sensitivity to any component of the study medications
- •Have a current infection requiring systemic antimicrobial treatment
- •Take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to Visit 1
- •Have used topical or systemic anti-inflammatory agents on the same day as Visit 1 and for the duration of the study
- •Have used topical or systemic pain medications on the same day as Visit 1 and for the duration of the study
- •Have used any topical otic treatment within 1 days prior to Visit 1
研究组 & 干预措施
FST-201 (dexamethasone 0.1%) Otic Suspension
Experimental
干预措施: FST-201 (dexamethasone 0.1%) Otic Suspension (Drug)
vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.
时间窗: 1 year
次要结局
- Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.(1 year)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
A Comparison of 188-0551 Solution Versus Vehicle Solution in Subjects With Plaque Psoriasis (Study 203)Plaque PsoriasisNCT03065556Therapeutics, Inc.89
已完成
2 期
A Six Week Topical Cream Study for Subjects With Ichthyosis VulgarisIchthyosis VulgarisNCT03173547Crown Laboratories, Inc.80
已完成
3 期
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye DiseaseDry Eye DiseaseNCT04735393Aldeyra Therapeutics, Inc.757
已完成
1 期
Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)Age-Related Macular DegenerationNCT02914639OcuTerra Therapeutics, Inc.44
已完成
1 期
Safety and Exploratory Efficacy Study of SF0166 for the Treatment of Diabetic Macular Edema (DME)Diabetic Macular EdemaNCT02914613OcuTerra Therapeutics, Inc.44