Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural Hearing Loss

Conditions
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Acute Hearing Loss

Intervention / Treatment
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* Drug: STR001-IT and STR001-ER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intratympanic gel injection followed by 12 weeks oral treatment intratympanic gel injection followed by 12 weeks oral treatment placebo intratympanic gel injection placebo followed by 12 weeks oral treatment placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STR001-IT/STR001-ER<br> | Drug: STR001-IT and STR001-ER<br>* STR001-IT intrataympanic injection and STR001-ER tablet<br>|
| Active Comparator: STR001-IT/STR001-ER Placebo<br> | Drug: STR001-IT and STR001-ER<br>* STR001-IT intrataympanic injection and STR001-ER tablet<br>|
| Placebo Comparator: STR001-IT placebo/STR001- ER placebo<br> | Drug: STR001-IT and STR001-ER<br>* STR001-IT intrataympanic injection and STR001-ER tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute hearing improvement after 12 weeks | Absolute hearing improvement after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous baseline frequencies (dB) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete hearing recovery after 12 weeks | Percentages of patients with complete hearing recovery after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous frequencies at baseline | 12 weeks |