Sudden Sensorineural Hearing Loss (SSHL) including - idiopathic unilateral Sensorineural Hearing Loss - acute uni- or bilateral acoustic trauma-induced Sensorineural Hearing Loss MedDRA version: 20.0 Level: LLT Classification code 10040016 Term: Sensorineural hearing loss System Organ Class: 100000004854
Conditions
Sponsors
STREKIN AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria in order to be eligible for this study: 1. Male or female patients aged = 18 2. Patients with a SSHL within 96 hours of its perception 3. Sudden Sensorineural Hearing Loss including a. idiopathic unilateral Sudden Sensorineural Hearing Loss or b. acute uni- or bilateral acoustic trauma-induced Sudden Sensorineural Hearing Loss 4. Mean hearing threshold of = 75 dB determined by PTA averaged at the three most affected contiguous frequencies. 5. Mean hearing loss of = 50 dB averaged across the 3 PTA frequencies compared to the contralateral ear, or reference value (in case of asymmetric hearing loss prior to the current case or acute bilateral acoustic trauma-induced SSHL). 6. Patients with an otoscopically intact eardrum 7. Patients must be willing and capable to perform all study procedures 8. Patients must be able to provide informed consent 9. Females must have a negative pregnancy test or must be post- menopausal 10. Patients willing and able to use adequate hearing protection and to refrain from engaging in acitivities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured 11. Able and willing to provide written informed consent and to comply with the study protocol according to ICH and local regulations. 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 165 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria by the day of randomization are not eligible for this study : 1. Patients with a history of Meniere’s Disease 2. Patients with endolymphatic, hydrops or history of fluctuating hearing loss 3. Patients with suspected perilymph fistula, membrane rupture, retrocochlear lesions or a barotrauma 4. Patients with an air-bone gap of = 20 dB in one of the 3 contiguous frequencies at baseline (frequencies defined with inclusion criterion 4) 5. Previous SSHL incident at the same ear 6. Patients with acute or chronic otitis media or otitis externa. 7. Patients with congenital hearing loss 8. Patients with known hypersensitivity to pioglitazone, other thiazolidindiones or any formulation component 9. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline 10. Any use of CYP450 2C8 inducers (e.g. rifampicine) 11. Patients with therapy of fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline 12. 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 13. Women who are breastfeeding, pregnant or plan to get pregnant during the trial duration 14. Women of childbearing potential unwilling or unable to practice effective method of contraception 15. Participation in other clinical trials in the last month prior to baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: - To evaluate the safety and tolerability of intratympanic administration of STR001-IT thermogel followed by oral treatment with STR001-ER in patients with Sudden Sensorineural Hearing Loss - To assess the efficacy of intratympanic administration of STR001-IT thermogel followed by oral treatment with STR001-ER in measuring hearing improvement at week 12 by PTA measurement at the 3 most contiguous affected frequencies seen at baseline;Secondary Objective: The secondary objectives for this study are: - To evaluate speech recognition improvement after 12 and 24 weeks - To evaluate the percentage (%) of patients with complete hearing recovery after 12 and 24 weeks measured with PTA - To evaluate hearing recovery (change in aPTA) after 4 weeks tested frequencies using PTA - To evaluate hearing recovery after 4 weeks in all tested frequencies the profound hearing loss (> 90 dB HL at baseline) subgroup - To evaluate hearing recovery after 12 weeks in all tested frequencies using PTA - To evaluate hearing recovery after 12 weeks in all tested frequencies for the profound hearing loss (> 90 dB HL at baseline) subgroup - To evaluate tinnitus burden after 12 and 24 weeks - To evaluate vertigo assessment after 12 and 24 weeks - To evaluate the systemic exposure of STR001 after intratympanic administration of STR001-IT thermogel followed by oral STR001-ER treatment after 4 and 12 weeks.;Primary end point(s): The Primary Efficacy assessment is at 12 weeks, of AHI (Average Hearing Improvement over the 3 contiguously affected baseline frequencies, using PTA, air conduction).;Timepoint(s) of evaluation of this end point: At week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are two key secondary endpoints in this study: - Measurement of speech recognition using a list with 20 words in local language at week 12 and 24. - Determination of the percentage of patients with complete hearing recovery after 12 weeks as assessed by PTA and;Timepoint(s) of evaluation of this end point: At week 12 and 24. | — |
Countries
Czech Republic, Germany, Poland, Russian Federation, Switzerland
Contacts
Public ContactKarsten Jaekel
Strekin AG
Outcome results
None listed