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:
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
