NCT01621256已完成1 期
Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in PTA (pure tone audiogram) in the affected ear
研究概览
简要总结
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
- •Symmetric hearing prior to onset of SSHL
- •Enrollment has to be accomplished within 7 days after SSHL onset
排除标准
- •Bilateral SSHL
- •Incomplete recovery after previous SSHL
- •Previously existing, known retrocochlear hearing loss
- •Any history of any ear operation or local inflammatory disease in the past one year
- •History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
- •History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
- •Treatment with steroids for any reason within the preceding 30 days.
- •Body weight > 140 kg
研究组 & 干预措施
Ancrod
Experimental
Ancrod
干预措施: Ancrod (Drug)
Saline solution
Placebo Comparator
Saline solution
干预措施: Saline solution (Drug)
结局指标
主要结局
Change in PTA (pure tone audiogram) in the affected ear
时间窗: From baseline to Day 8
次要结局
- Change in speech recognition in the affected ear(From baseline to Day 8)
研究者
研究点 (2)
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