EUCTR2015-002672-25-ES进行中（未招募）1 期
A Phase II multicenter, placebo-controlled, proof-of-concept study evaluating the safety, and efficacy of intratympanic STR001 thermogel to preserve residual hearing in adults undergoing cochlear implant surgery
适应症
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
- 110
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
- •1. Males or females aged between > 18 years and = 80 years
- •2. Patients with a diagnosis of severe to profound hearing loss with < 80 dB by average Pure Tone Audiometry measured at the frequencies of 125, 250, 500 and 750Hz, eligible for cochlear implant surgery (average up to 82.5 will be rounded down to 80 i.e. will be considered eligible).
- •3. Patients must be willing and capable to perform all study procedures
- •4. Patients have understood the patient information documents and have provided informed consent
- •5. Females must have a negative serum pregnancy test or must be post- menopausal
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1. Malformation or cochlear ossification
- •2. Developmental disabilities or psychiatric diseases such as severe depression
- •3. History of Meniere’s disease
- •4. Acute or chronic middle ear inflammatory disease
- •5. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
- •6. Chronic (i.e. at least 3 continuous months) oral steroids in the last 6 months prior to baseline
- •7. Daily nasal/pulmonary steroid in the last month prior to baseline
- •8. Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to Baseline
- •9. Patients with known hypersensitivity to pioglitazone or any formulation component
- •10. Initiation of treatment with lipophilic statins (e.g. atorvastatin, pitavastatin, lovastatin, fluvastatin or simvastatin) in the month prior to inclusion in the study. Patients on stable doses of lipophilic statins should continue therapy during the study.
- •11. Any drug-based therapy for inner ear hearing loss in the last month prior to baseline
- •12. Women who are breast feeding, pregnant, or plan to get pregnant during the trial
- •13. Women of childbearing potential unwilling/unable to practice contraception
- •14. Participation in other clinical trials in the last month prior to baseline
- •15. Patients who are institutionalized upon authorities or legal request
- •16. Patients who are vulnerable (e.g. employees or relatives of sponsor, investigator or investigational site staff or patients in emergency situations)
- •17. 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)
研究者
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