Title
Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL
A Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural Hearing Loss
Phase
Phase 3Lead Sponsor
Strekin AGStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Acute Hearing LossIntervention/Treatment
STR001-IT and STR001-ERStudy Participants
165a 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.
STR001-IT intrataympanic injection and STR001-ER tablet
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