NCT00957788终止1 期
Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus
NeuroSystec Corporation2 个研究点 分布在 2 个国家目标入组 8 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Subjects will be followed for identification and frequency of drug or procedure-related adverse events.
研究概览
简要总结
This research study involves an experimental drug (NST_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients able to provide voluntary consent.
- •Severe tinnitus in one ear that began no more than ten years ago.
- •Ear to be treated must be deaf or have profound hearing loss.
- •Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months.
- •Subject must have intact cochlear nerve on the ear to be treated.
- •Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician.
排除标准
- •Current diagnosis of bilateral tinnitus.
- •Current diagnosis or history of pancreatitis.
- •Females that are pregnant or lactating.
- •Use of investigational drugs within the previous 30 days.
- •History of drug dependency or other substance abuse.
研究组 & 干预措施
Cohort 0
Experimental
干预措施: NST-001 (Drug)
Cohort 1
Experimental
干预措施: NST-001 (Drug)
Cohort 2
Experimental
干预措施: NST-001 (Drug)
Cohort 3
Experimental
干预措施: NST-001 (Drug)
结局指标
主要结局
Subjects will be followed for identification and frequency of drug or procedure-related adverse events.
时间窗: At each follow-up visit.
次要结局
- Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview.(At each follow-up visit.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With ObesityObesityNCT06049329Novo Nordisk A/S36
已完成
1 期
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 DiabetesHealthy VolunteersDiabetes Mellitus, Type 1NCT04569994Novo Nordisk A/S68
终止
1 期
A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced MalignanciesAdvanced Solid TumorsNCT03522142Incyte Corporation83
终止
1 期
Neoadjuvant Chemoradiation Plus Pembrolizumab Followed By Consolidation Pembrolizumab in NSCLCStage IIIA Non-Small Cell Lung CancerNCT02987998Nathan Pennell, MD, PhD9
已完成
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid TumorsAdvanced Solid TumorMSI-H/dMMR TumorsCutaneous Squamous Cell CarcinomaUrothelial CarcinomaEsophageal Squamous Cell CarcinomaCervical CancerHepatoCellular CarcinomaSmall-cell Lung CancerMesotheliomaPD-L1 Amplified Tumor (9p24.1)Merkel Cell CarcinomaNasopharyngeal CarcinomaNCT04242199Incyte Corporation182