NCT00802425已完成2 期
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Hearing loss
研究概览
简要总结
The purpose of the study is to determine whether AM-111 is effective in the treatment of acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral acute sensorineural hearing loss (ASNHL) with onset 48 hours or less ago
- •Mean earing loss compared with the unaffected contralateral ear of at least 30 dB in the 3 most affected contiguous frequencies
- •Age ≥ 18 years and ≤ 60 years
- •Negative pregnancy test for women of childbearing potential
- •Able to attend the on-study visits
- •Written informed consent before participation in the study
排除标准
- •Bilateral ASNHL, if not resulting from acoustic trauma
- •Suspected perilymph fistula or membrane rupture
- •Barotrauma
- •Average air bone gap higher than 20 dB in 3 contiguous frequencies
- •History of Meniere disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion or fluctuating hearing loss
- •Previous ASNHL incident within the past 6 weeks
- •Evidence of acute or chronic otitis media or otitis externa on examination
- •Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks
- •Any ongoing or planned concomitant medication for the treatment of tinnitus until 30 days after administration
- •Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion
- •History of drug abuse or alcoholism
- •Any clinically relevant respiratory, cardiovascular, neurological (except vertigo or tinnitus), or psychiatric disorders
- •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 combined oral contraceptives, injectables, hormonal intra-uterine devices, vasectomised partner or sexual abstinence
- •Concurrent participation in another clinical trial or participation in another clinical trial within 30 days prior to study entry
- •Any current anticoagulant therapy (e.g. Aspirin, Marcumar, etc)
研究组 & 干预措施
1
Placebo Comparator
干预措施: placebo (Drug)
2
Experimental
AM-111 low dose
干预措施: AM-111 (Drug)
3
Experimental
AM-111 high dose
干预措施: AM-111 (Drug)
结局指标
主要结局
Hearing loss
时间窗: 7 days
Average change in hearing loss in dB between the baseline and D7 for the three contiguous frequencies with the worst hearing loss, identified at study entry
次要结局
- Hearing loss(Days 3, 30, 90)
研究者
研究点 (1)
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终止
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Efficacy of AM 111 in Patients with Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II StudyAcute sensorineural hearing loss (ASNHL), which may be triggered by acoustic trauma, middle or inner ear surgery, i.e. known or evident insults to the inner ear. ASNHL may also result from a variety of other insults such as bacterial or viral infections, inflammation, vascular compromise, autoimmune disorders or mechanical damage, which may not be directly observable.MedDRA version: 14.1Level: LLTClassification code 10040016Term: Sensorineural hearing lossSystem Organ Class: 10013993 - Ear and labyrinth disordersEUCTR2008-000132-40-DEAuris Medical AG204
进行中（未招募）
不适用
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