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

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