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NCT04129775 · ClinicalTrials.gov registry record · Phase 1
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
A Phase 1 study of Sensorineural Hearing Loss, sponsored by Otonomy.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 8
- Study locations
NCT04129775 is a Phase 1 study of Sensorineural Hearing Loss that has completed, run by Otonomy. The registered enrollment target is 110 participants, below the 122-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (10% lower). The trial reports 8 study locations across 6 states.
The verdict
NCT04129775, a Phase 1 study of Sensorineural Hearing Loss, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OTO-413
Study Locations (8)
Florida
- Research Centers of America - Hollywood
- South Florida ENT Associates or Research Centers of America - Miami
- University of South Florida - Tampa
Colorado
- Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy - Colorado Springs
Kentucky
- Advanced ENT and Allergy, PLLC - Louisville
North Carolina
- Piedmont Ear, Nose & Throat Associates - Winston-Salem
Utah
- JBR Clinical Research - Salt Lake City
Virginia
- Eastern Virginia Medical School, Department of Otolaryngology - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2022-09-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04129775
The ClinicalTrials.gov registry entry for NCT04129775 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 122-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (10% lower). The listed sponsor is Otonomy, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sensorineural Hearing Loss appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04129775 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Florida, Colorado, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04129775 about?
NCT04129775 is a clinical study titled "OTO-413 in Subjects With Speech-in-Noise Hearing Impairment". 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.
What is the current status of trial NCT04129775?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2019-10-01. Estimated completion is 2022-09-05.
What conditions does trial NCT04129775 study?
This clinical trial studies the following conditions: Sensorineural Hearing Loss.
What interventions are being tested in trial NCT04129775?
The interventions under investigation include: Placebo (DRUG), OTO-413 (DRUG).
Who is sponsoring clinical trial NCT04129775?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04129775 being conducted?
This trial has 8 study locations across Colorado, Florida, Kentucky, North Carolina, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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