Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL

Acute Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331627
• Other study ID #: 2017-000242-22
• Status: Completed
• Phase: Phase 3
• Start date: February 24, 2018
• Est. completion date: February 6, 2020

Study information

• Verified date: April 2019
• Source: Strekin AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hearing Loss
• Deafness
• Hearing Loss

Intervention

Drug:
• STR001-IT and STR001-ER
STR001-IT intrataympanic injection and STR001-ER tablet

Locations

Country	Name	City	State
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Germany	Universitätsklinik Freiburg	Freiburg
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Strekin AG

Countries where clinical trial is conducted

Czechia,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute hearing improvement after 12 weeks	Absolute hearing improvement after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous baseline frequencies (dB)	12 weeks
Secondary	complete hearing recovery after 12 weeks	Percentages of patients with complete hearing recovery after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous frequencies at baseline	12 weeks