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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331627
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Strekin AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Hearing Loss Drug: STR001-IT and STR001-ER Phase 3

Study Design
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Study Type : Interventional
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : February 24, 2018
Actual Primary Completion Date : February 6, 2020
Actual Study Completion Date : February 6, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: STR001-IT/STR001-ER Drug: STR001-IT and STR001-ER
STR001-IT intrataympanic injection and STR001-ER tablet
Active Comparator: STR001-IT/STR001-ER Placebo Drug: STR001-IT and STR001-ER
STR001-IT intrataympanic injection and STR001-ER tablet
Placebo Comparator: STR001-IT placebo/STR001- ER placebo Drug: STR001-IT and STR001-ER
STR001-IT intrataympanic injection and STR001-ER tablet


Outcome Measures
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Primary Outcome Measures :
  1. Absolute hearing improvement after 12 weeks [ Time Frame: 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 :
  1. complete hearing recovery after 12 weeks [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331627


Locations
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Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czechia
Germany
Universitätsklinik Freiburg
Freiburg, Germany, 79106
Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Strekin AG
More Information
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Responsible Party: Strekin AG
ClinicalTrials.gov Identifier: NCT03331627    
Other Study ID Numbers: 2017-000242-22
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases