Acute Hearing LossPhase 3NCT03331627
Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL
A Phase 3 study testing STR001-IT and STR001-ER in people with Acute Hearing Loss, run by Strekin AG at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hearing Loss
- What is being tested?
- STR001-IT and STR001-ER
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 24 Feb 2018to 6 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
- Conditions
- Acute Hearing Loss
- Being tested
- STR001-IT and STR001-ER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STR001-IT and STR001-ERDrug
STR001-IT intrataympanic injection and STR001-ER tablet
| Study group | Role | What they receive |
|---|---|---|
| STR001-IT/STR001-ER | Active comparator | Not described Receives: Drug: STR001-IT and STR001-ER |
| STR001-IT/STR001-ER Placebo | Active comparator | Not described Receives: Drug: STR001-IT and STR001-ER |
| STR001-IT placebo/STR001- ER placebo | Placebo comparator | Not described Receives: Drug: STR001-IT and STR001-ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start24 Feb 2018
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strekin AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331627
- Sponsor's protocol ID
- 2017-000242-22
- Other IDs
- 2017
- Status last verified
- Apr 2019
- First submitted
- 1 Nov 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03331627
- Acronym / sponsor ID
- 2017-000242-22
- Conditions
- Acute Hearing Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Strekin AGIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2018 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| STR001-IT/STR001-ER | Active comparator | Drug: STR001-IT and STR001-ER |
| STR001-IT/STR001-ER Placebo | Active comparator | Drug: STR001-IT and STR001-ER |
| STR001-IT placebo/STR001- ER placebo | Placebo comparator | Drug: STR001-IT and STR001-ER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged ≥ 18
- Patients with a SSHL within 96 hours of its perception
- Sudden Sensorineural Hearing Loss including
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STR001-IT and STR001-ERSTR001-IT intrataympanic injection and STR001-ER tablet | Drug | STR001-IT placebo/STR001- ER placebo, STR001-IT/STR001-ER, STR001-IT/STR001-ER Placebo |
Primary outcome
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)
1 secondary outcome
complete hearing recovery after 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
Related trials for Acute Hearing Loss
Not yet recruitingPhase 3
Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
Acute Spinal Cord Injury (SCI)
Recruiting
A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
Sensori-Neural Deafness, Exosomes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STR001-IT and STR001-ER in people with Acute Hearing Loss, run by Strekin AG at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute hearing improvement after 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.