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

Strekin AG0 个研究点目标入组 110 人开始时间: 2015年9月21日最近更新: 2019年1月7日

试验速览

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•1. Males or females aged between =18 years and = 80 years
•2. Patients with a diagnosis of moderate to severe 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

•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 STR001 or any formulation component
•10. Initiation of treatment with lipophilic statins (e.g. atorvastatin, pitavastatin, lovastatin, fluvastatin or simvastatin) in the last 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 that is ongoing or was performed in the past month prior to baseline

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