EUCTR2015-002672-25-ITActive, not recruitingPhase 1
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 - STR001-201
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- STREKIN AG
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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 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
- •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)
Investigators
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