NCT05776459进行中（未招募）2 期
Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 39
- 主要终点
- Change in pure tone audiometry (PTA; dB)
研究概览
简要总结
The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 85 years
- •Unilateral ISSNHL
- •Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
- •An absolute air conduction hearing threshold of at least 65 dB,
- •Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear
排除标准
- •Insufficient handling of the language used in the speech audiometry tests
- •Bilateral hearing loss
- •Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
- •Congenital hearing loss
- •Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB
- •History of ISSNHL in the past 1 years in the affected ear
研究组 & 干预措施
Prednisolone
Active Comparator
Placebo gel and prednisolone tablets
干预措施: Prednisolone (Drug)
AC102
Experimental
AC102 gel and placebo tablets
干预措施: AC102 gel (Drug)
AC102
Experimental
AC102 gel and placebo tablets
干预措施: Placebo Tablets (Other)
Prednisolone
Active Comparator
Placebo gel and prednisolone tablets
干预措施: Placebo gel (Other)
结局指标
主要结局
Change in pure tone audiometry (PTA; dB)
时间窗: 28 days
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28
次要结局
- Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists(14, 28, 56, 84 days)
研究者
研究点 (39)
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