Status:
COMPLETED
Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL
Lead Sponsor:
Strekin AG
Conditions:
Acute Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2020
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT03331627
Start Date
February 24 2018
End Date
February 6 2020
Last Update
March 25 2020
Active Locations (3)
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1
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
2
Universitätsklinik Freiburg
Freiburg im Breisgau, Germany, 79106
3
Universitätsspital Zürich
Zurich, Switzerland, 8091