Hearing Loss, SuddenPhase 1/2NCT04766853
Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss
A Phase 1/2 study testing Dexamethasone and Hyaluronic acid in people with Hearing Loss, Sudden and Hearing Loss, Ototoxic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hearing Loss, Sudden, Hearing Loss, Ototoxic, Hearing Loss, Noise-Induced
- What is being tested?
- Dexamethasone and Hyaluronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2021to 19 Jul 2024
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry
- Patients whose hearing has not been restored after standard treatment
- Patients do not participate in clinical trials within 6 months
Who cannot join
- Patients with retrocochlear lesion
- Patients with history of hypersensitivity to the ingredients of this drug
- Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (pilot Study)
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
- Conditions
- Hearing Loss, Sudden, Hearing Loss, Ototoxic, Hearing Loss, Noise-Induced, Meniere Disease
- Being tested
- Dexamethasone, Hyaluronic acid
- Keywords
- Hearing loss, Drug Delivery, Dexamethasone, Hyaluronic Acid, Intratympanic injection
- Medical subject headings
- Hearing Loss, Sudden, Hearing Loss, Hearing Loss, Noise-Induced, Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 5mg/ml
Hyaluronic acidDrug
Hyaluronic Acid 20mg/2ml
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone+Saline | Active comparator | Not described Receives: Drug: Dexamethasone |
| Dexamethasone+Hyaluronic Acid | Experimental | Not described Receives: Drug: Dexamethasone; Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of tympanic membrane with endoscopy (Safety)
Confirming healing time of perforation and inflammation
Measured: 3-4 weeks after intratympanic injection
Confirmation of inflammation and drug with CT imaging (Durability)
Checking a time duration of drug in middle and inner ear
Measured: 1 day and/or 1 weeks after intratympanic injection
Valuation of hearing threshold with Pure tone audiometry (Efficacy)
Verifying therapeutic effect of intratympanic drug delivery vehicle
Measured: 3-4 weeks after intratympanic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start22 Jul 2021
- Primary completion18 Apr 2023
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SuddenStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766853
- Sponsor's protocol ID
- H-1812-128-997
- Status last verified
- Jul 2024
- First submitted
- 17 Feb 2021
- Last updated
- 24 Oct 2024
- 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (pilot Study)
- ClinicalTrials.gov ID
- NCT04766853
- Acronym / sponsor ID
- H-1812-128-997
- Conditions
- Hearing Loss, Sudden, Hearing Loss, Ototoxic, Hearing Loss, Noise-Induced, Meniere Disease
- Keywords
- Hearing loss, Drug Delivery, Dexamethasone, Hyaluronic Acid, Intratympanic injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 23 Feb 2021 (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.
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone+Saline | Active comparator | Drug: Dexamethasone |
| Dexamethasone+Hyaluronic Acid | Experimental | Drug: Dexamethasone, Drug: Hyaluronic acid |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry
- Patients whose hearing has not been restored after standard treatment
- Patients do not participate in clinical trials within 6 months
Key exclusion criteria (3 listed)
- Patients with retrocochlear lesion
- Patients with history of hypersensitivity to the ingredients of this drug
- Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.
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 |
|---|---|---|
| DexamethasoneDexamethasone 5mg/ml | Drug | Dexamethasone+Hyaluronic Acid, Dexamethasone+Saline |
| Hyaluronic acidHyaluronic Acid 20mg/2ml | Drug | Dexamethasone+Hyaluronic Acid |
Primary outcome
Verification of tympanic membrane with endoscopy (Safety)
Time frame: 3-4 weeks after intratympanic injection
Confirming healing time of perforation and inflammation
Confirmation of inflammation and drug with CT imaging (Durability)
Time frame: 1 day and/or 1 weeks after intratympanic injection
Checking a time duration of drug in middle and inner ear
Valuation of hearing threshold with Pure tone audiometry (Efficacy)
Time frame: 3-4 weeks after intratympanic injection
Verifying therapeutic effect of intratympanic drug delivery vehicle
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 24 Oct 2024.
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Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
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Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone and Hyaluronic acid in people with Hearing Loss, Sudden and Hearing Loss, Ototoxic, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 3 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Verification of tympanic membrane with endoscopy (Safety) (time frame: 3-4 weeks after intratympanic injection). The study lists 3 primary outcomes in all. 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 24 Oct 2024.