Clinical trial NCT03331627: Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL
Official title: A Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Hearing Loss
Lead sponsor: Strekin AG
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. intratympanic gel injection followed by 12 weeks oral treatment
2. intratympanic gel injection followed by 12 weeks oral treatment placebo
3. intratympanic gel injection placebo followed by 12 weeks oral treatment placebo
Primary purpose: TREATMENT

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) and corresponding Placebo on top of standard of care.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged ≥ 18
2. Patients with a SSHL within 96 hours of its perception
3. Sudden Sensorineural Hearing Loss including

   1. idiopathic unilateral Sudden Sensorineural Hearing Loss or
   2. acute uni- or bilateral acoustic trauma-induced Sudden Sensorineural Hearing Loss

Exclusion Criteria:

1. Patients with a history of Meniere's Disease
2. Patients with a hearing threshold above 100 dB across at least 6 frequencies
3. Patients with endolymphatic, hydrops or history of fluctuating hearing loss
4. Patients with suspected perilymph fistula, membrane rupture, retrocochlear lesions or a barotrauma
5. Patients with an air-bone gap of ≥ 20 dB in 3 contiguous frequencies at baseline
6. Previous SSHL incident at the same ear
7. Patients with acute or chronic otitis media or otitis externa.
8. Patients with congenital hearing loss
9. Patients with known hypersensitivity to pioglitazone, other thiazolidindiones or any formulation component
10. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
11. Any use of CYP450 2C8 inducers (e.g. rifampicine)
12. Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline
13. 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
14. Women who are breastfeeding, pregnant or plan to get pregnant during the trial duration
15. Women of childbearing potential unwilling or unable to practice effective method of contraception
16. Participation in other clinical trials in the last month prior to baseline

Primary outcomes:
measure: Absolute hearing improvement after 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: complete hearing recovery after 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
References: