NCT03331627已完成3 期
A Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural Hearing Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Strekin AG
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Absolute hearing improvement after 12 weeks
研究概览
简要总结
a multicenter, double-blind, placebo-controlled study in patients with Sudden Sensorineural Hearing Loss (SSHL). Patients will be treated with STR001 thermogel (STR001-IT) / STR001 tablets (STR001-ER) and corresponding Placebo on top of standard of care.
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)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥ 18
- •Patients with a SSHL within 96 hours of its perception
- •Sudden Sensorineural Hearing Loss including
- •idiopathic unilateral Sudden Sensorineural Hearing Loss or
- •acute uni- or bilateral acoustic trauma-induced Sudden Sensorineural Hearing Loss
排除标准
- •Patients with a history of Meniere's Disease
- •Patients with a hearing threshold above 100 dB across at least 6 frequencies
- •Patients with endolymphatic, hydrops or history of fluctuating hearing loss
- •Patients with suspected perilymph fistula, membrane rupture, retrocochlear lesions or a barotrauma
- •Patients with an air-bone gap of ≥ 20 dB in 3 contiguous frequencies at baseline
- •Previous SSHL incident at the same ear
- •Patients with acute or chronic otitis media or otitis externa.
- •Patients with congenital hearing loss
- •Patients with known hypersensitivity to pioglitazone, other thiazolidindiones or any formulation component
- •Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
- •Any use of CYP450 2C8 inducers (e.g. rifampicine)
- •Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline
- •Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
- •Women who are breastfeeding, pregnant or plan to get pregnant during the trial duration
- •Women of childbearing potential unwilling or unable to practice effective method of contraception
- •Participation in other clinical trials in the last month prior to baseline
研究组 & 干预措施
STR001-IT/STR001-ER
Active Comparator
干预措施: STR001-IT and STR001-ER (Drug)
STR001-IT/STR001-ER Placebo
Active Comparator
干预措施: STR001-IT and STR001-ER (Drug)
STR001-IT placebo/STR001- ER placebo
Placebo Comparator
干预措施: STR001-IT and STR001-ER (Drug)
结局指标
主要结局
Absolute hearing improvement after 12 weeks
时间窗: 12 weeks
Absolute hearing improvement after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous baseline frequencies (dB)
次要结局
- complete hearing recovery after 12 weeks(12 weeks)
研究者
研究点 (3)
Loading locations...
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