Title

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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    165
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.
Study Started
Feb 24
2018
Primary Completion
Feb 06
2020
Study Completion
Feb 06
2020
Last Update
Mar 25
2020

Drug STR001-IT and STR001-ER

STR001-IT intrataympanic injection and STR001-ER tablet

STR001-IT/STR001-ER Active Comparator

STR001-IT/STR001-ER Placebo Active Comparator

STR001-IT placebo/STR001- ER placebo Placebo Comparator

Criteria

Inclusion Criteria:

Male or female patients aged ≥ 18
Patients with a SSHL within 96 hours of its perception

Sudden Sensorineural Hearing Loss including

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

Exclusion Criteria:

Patients with a history of Meniere's Disease
Patients with a hearing threshold above 100 dB across at least 6 frequencies
Patients with endolymphatic, hydrops or history of fluctuating hearing loss
Patients with suspected perilymph fistula, membrane rupture, retrocochlear lesions or a barotrauma
Patients with an air-bone gap of ≥ 20 dB in 3 contiguous frequencies at baseline
Previous SSHL incident at the same ear
Patients with acute or chronic otitis media or otitis externa.
Patients with congenital hearing loss
Patients with known hypersensitivity to pioglitazone, other thiazolidindiones or any formulation component
Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
Any use of CYP450 2C8 inducers (e.g. rifampicine)
Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline
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
Women who are breastfeeding, pregnant or plan to get pregnant during the trial duration
Women of childbearing potential unwilling or unable to practice effective method of contraception
Participation in other clinical trials in the last month prior to baseline
No Results Posted