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
2
Experimental
AM-111 low dose
干预措施: AM-111 (Drug)
1
Placebo Comparator
干预措施: placebo (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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