NCT01270282已完成2 期
Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
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
- 82
- 试验地点
- 16
- 主要终点
- The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
研究概览
简要总结
The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.
排除标准
- •Tinnitus that is not completely maskable
- •Fluctuating tinnitus
- •Intermittent tinnitus
- •Meniere's Disease
- •Ongoing acute or chronic otitis media or otitis externa.
研究组 & 干预措施
AM-101 0.81 mg/mL
Experimental
Gel for injection; single or triple injection
干预措施: AM-101 0.81 mg/mL (Drug)
Placebo
Placebo Comparator
Gel for injection; single or triple injection
干预措施: Placebo (Drug)
结局指标
主要结局
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
时间窗: 90 or 104 days
次要结局
- Standard audiological evaluations(90 or 104 days)
- Questionnaires evaluating the impact of tinnitus(90 or 104 days)
- Pharmacokinetic measures(3 or 14 days)
研究者
研究点 (16)
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