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

Primary Purpose

Acute Hearing Loss

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

STR001-IT and STR001-ER

About this trial

This is an interventional treatment trial for Acute Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Fakultni nemocnice Hradec Kralove
Universitätsklinik Freiburg
Universitätsspital Zürich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

STR001-IT/STR001-ER

STR001-IT/STR001-ER Placebo

STR001-IT placebo/STR001- ER placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03331627

First Posted

November 1, 2017

Last Updated

March 24, 2020

Sponsor

Strekin AG

1. Study Identification

Unique Protocol Identification Number

NCT03331627

Brief Title

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

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

February 24, 2018 (Actual)

Primary Completion Date

February 6, 2020 (Actual)

Study Completion Date

February 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Strekin AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Hearing Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

intratympanic gel injection followed by 12 weeks oral treatment intratympanic gel injection followed by 12 weeks oral treatment placebo intratympanic gel injection placebo followed by 12 weeks oral treatment placebo

Masking

ParticipantInvestigator

Masking Description

double-blind

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STR001-IT/STR001-ER

Arm Type

Active Comparator

Arm Title

STR001-IT/STR001-ER Placebo

Arm Type

Active Comparator

Arm Title

STR001-IT placebo/STR001- ER placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

STR001-IT and STR001-ER

Intervention Description

STR001-IT intrataympanic injection and STR001-ER tablet

Primary Outcome Measure Information:

Title

Absolute hearing improvement after 12 weeks

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

complete hearing recovery after 12 weeks

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Fakultni nemocnice Hradec Kralove

City

Hradec Kralove

Country

Czechia

Facility Name

Universitätsklinik Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Universitätsspital Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

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

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