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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 : Completed
First Posted : November 6, 2017
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Strekin AG

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE February 24, 2018
Actual Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
hearing loss [ 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
hearing loss [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL
Official Title  ICMJE A Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Acute Hearing Loss
Intervention  ICMJE Drug: STR001-IT and STR001-ER
STR001-IT intrataympanic injection and STR001-ER tablet
Study Arms  ICMJE
  • Active Comparator: STR001-IT/STR001-ER
    Intervention: Drug: STR001-IT and STR001-ER
  • Active Comparator: STR001-IT/STR001-ER Placebo
    Intervention: Drug: STR001-IT and STR001-ER
  • Placebo Comparator: STR001-IT placebo/STR001- ER placebo
    Intervention: Drug: STR001-IT and STR001-ER
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2017)
165
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 6, 2020
Actual Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331627
Other Study ID Numbers  ICMJE 2017-000242-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Strekin AG
Study Sponsor  ICMJE Strekin AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Strekin AG
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP