OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Public ClinicalTrials.gov record NCT04129775. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.
Study identification
- NCT ID
- NCT04129775
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 110 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2019 (Actual)
- Primary completion
- Sep 5, 2022 (Actual)
- Completion
- Sep 5, 2022 (Actual)
- Last update posted
- Oct 27, 2022
2019 – 2022
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy | Colorado Springs | Colorado | 80923 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| South Florida ENT Associates or Research Centers of America | Miami | Florida | 33156 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Advanced ENT and Allergy, PLLC | Louisville | Kentucky | 40220 | — |
| Piedmont Ear, Nose & Throat Associates | Winston-Salem | North Carolina | 27103 | — |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | — |
| Eastern Virginia Medical School, Department of Otolaryngology | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04129775, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 27, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04129775 live on ClinicalTrials.gov.