EUCTR2017-000242-22-DE进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- STREKIN AG
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet all of the following criteria in order to be eligible for this study:
- •1. Male or female patients aged = 18
- •2. Patients with a SSHL within 96 hours of its perception
- •3. Sudden Sensorineural Hearing Loss including
- •a. idiopathic unilateral Sudden Sensorineural Hearing Loss or
- •b. acute uni- or bilateral acoustic trauma-induced Sudden Sensorineural Hearing Loss
- •4. Mean hearing threshold of = 75 dB determined by PTA averaged at the three most affected contiguous frequencies.
- •5. Mean hearing loss of = 50 dB averaged across the 3 PTA frequencies compared to the contralateral ear, or reference value (in case of asymmetric hearing loss prior to the current case or acute bilateral acoustic trauma-induced SSHL).
- •6. Patients with an otoscopically intact eardrum
- •7. Patients must be willing and capable to perform all study procedures
- •8. Patients must be able to provide informed consent
- •9. Females must have a negative pregnancy test or must be post- menopausal
- •10. Patients willing and able to use adequate hearing protection and to refrain from engaging in acitivities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured
- •11. Able and willing to provide written informed consent and to comply with the study protocol according to ICH and local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 165
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following criteria by the day of randomization are not eligible for this study :
- •1. Patients with a history of Meniere’s Disease
- •2. Patients with endolymphatic, hydrops or history of fluctuating hearing loss
- •3. Patients with suspected perilymph fistula, membrane rupture, retrocochlear lesions or a barotrauma
- •4. Patients with an air-bone gap of = 20 dB in one of the 3 contiguous frequencies at baseline (frequencies defined with inclusion criterion 4)
- •5. Previous SSHL incident at the same ear
- •6. Patients with acute or chronic otitis media or otitis externa.
- •7. Patients with congenital hearing loss
- •8. Patients with known hypersensitivity to pioglitazone, other thiazolidindiones or any formulation component
- •9. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
- •10. Any use of CYP450 2C8 inducers (e.g. rifampicine)
- •11. Patients with therapy of fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline
- •12. 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
- •13. Women who are breastfeeding, pregnant or plan to get pregnant during the trial duration
- •14. Women of childbearing potential unwilling or unable to practice effective method of contraception
- •15. Participation in other clinical trials in the last month prior to baseline
研究者
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