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

NCT ID: NCT03331627

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-24
• Study Completion Date: 2020-02-06

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.

Conditions

Acute Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

STR001-IT/STR001-ER

Group Type: ACTIVE_COMPARATOR

STR001-IT and STR001-ER

Intervention Type: DRUG

STR001-IT intrataympanic injection and STR001-ER tablet

STR001-IT/STR001-ER Placebo

Group Type: ACTIVE_COMPARATOR

STR001-IT and STR001-ER

Intervention Type: DRUG

STR001-IT intrataympanic injection and STR001-ER tablet

STR001-IT placebo/STR001- ER placebo

Group Type: PLACEBO_COMPARATOR

STR001-IT and STR001-ER

Intervention Type: DRUG

STR001-IT intrataympanic injection and STR001-ER tablet

Interventions

STR001-IT and STR001-ER

STR001-IT intrataympanic injection and STR001-ER tablet

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Strekin AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Universitätsklinik Freiburg

Freiburg im Breisgau, , Germany

Universitätsspital Zürich

Zurich, , Switzerland

Countries

Czechia; Germany; Switzerland

Other Identifiers

2017-000242-22

Identifier Type: -

Identifier Source: org_study_id