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

A Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural Hearing Loss

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03331627

Enrollment

165

Registered

2017-11-06

Start date

2018-02-24

Completion date

2020-02-06

Last updated

2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hearing Loss

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.

Interventions

DRUGSTR001-IT and STR001-ER

STR001-IT intrataympanic injection and STR001-ER tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double-blind

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Absolute hearing improvement after 12 weeks	12 weeks	Absolute hearing improvement after 12 weeks measured with PTA using the mean value of the 3 most affected contiguous baseline frequencies (dB)

Secondary

Measure	Time frame	Description
complete hearing recovery after 12 weeks	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

Countries

Czechia, Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026