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

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ClinicalTrials.gov Identifier: NCT03331627
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Strekin AG

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019


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




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



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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

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


Contacts
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Contact: Strekin AG

Locations
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Czechia
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czechia
Contact: Viktor Chrobok    +420 495 833 790    chrobok@fnhk.cz   
Germany
Universitätsklinik Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Susan Arndt    0049 761 270 42120    susan.arndt@uniklinik-freiburg.de   
Switzerland
Universitätsspital Zürich Recruiting
Zürich, Switzerland, 8091
Contact: Tobias Kleinjung    004144 255 5900    Tobias.Kleinjung@usz.ch   
Sponsors and Collaborators
Strekin AG

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Responsible Party: Strekin AG
ClinicalTrials.gov Identifier: NCT03331627     History of Changes
Other Study ID Numbers: 2017-000242-22
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 10, 2019
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
Signs and Symptoms