EUCTR2008-005178-10-BE进行中（未招募）1 期
Efficacy of AM 101 in Patients with Acute Inner Ear Tinnitus: A Multi-Centre, Double-Blind, randomised, Placebo-Controlled, Multiple Dose, Group Comparison Phase II Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Persistent tinnitus following acute acoustic trauma, sudden deafness, or acute otitis media with onset less than three months ago (i.e. acute tinnitus)
- •Tinnitus provoking incident of acute acoustic trauma, sudden deafness, or acute otitis media is documented by medical report
- •Minimum Masking Level (MML) of at least 5 dB SL
- •Age = 18 years and = 65 years
- •Negative pregnancy test for women of childbearing potential
- •Willing and able to attend the on-study visits
- •Must be able to read and understand the relevant study documents
- •Written informed consent before participation in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Tinnitus that is not completely maskable
- •Fluctuating tinnitus
- •Intermittent tinnitus
- •Meniere’s Disease
- •Acute or chronic otitis media or otitis externa
- •Any ongoing therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin, quinine etc.)
- •Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks, e.g. prednisolone, dexamethasone, pentoxyfilline, betahistine, diazepam, carbamazepine, sodium valproate and antidepressants
- •Any drug-based therapy for otitis media that is ongoing or was performed in the past 2 weeks
- •Concomitant use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan, ifenprodil)
- •Any ongoing or planned concomitant medication for the treatment of tinnitus until 90 days after study drug application
- •History or presence of drug abuse or alcoholism
- •Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder
- •Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
- •Women who are breast-feeding, pregnant or who plan a pregnancy during the trial
- •Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
- •Concurrent participation in another clinical trial with an investigational drug or participation in another clinical trial with an investigational drug within 30 days prior to study entry
研究者
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