ACTRN12621000964819招募中1 期
A Prospective, Placebo Controlled, Single-Blind Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease (SPT-2101 Safety in Meniere’s Disease Study)
Spiral Therapeutics Australia Pty Ltd0 个研究点目标入组 40 人开始时间: 2021年7月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Age 18 years to 85 years (inclusive) at the time of screening
- •2. Provides written informed consent prior to participation in any study procedure
- •3. Has a diagnosis of unilateral Definite Meniere's disease defined by the Classification Committee of the Bárány Society or the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
- •4. Self-reports active, definitive vertigo (lasting 20 minutes or more) in the 3 months prior to screening and records 2 or more Definitive Vertigo Days in the lead-in period.
- •5. Has documented acquired asymmetric sensorineural hearing loss, as reported by the patient or documented by audiometric testing
排除标准
- •1. Ongoing chronic inflammatory or infectious middle ear disease
- •2. Active infection in the ear, sinuses, or upper respiratory system
- •3. Current tympanic membrane perforation, including ventilation tube, in the affected ear.
- •4. Active benign paroxysmal positional vertigo (BPPV) symptoms
- •5. History of superior canal dehiscence
研究者
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