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NCT04829214 · ClinicalTrials.gov registry record · Phase 2
OTO-313 in Subjects With Unilateral Subjective Tinnitus
A Phase 2 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
NCT04829214: Completed Phase 2 study, sponsored by Otonomy.
NCT04829214 is a Phase 2 study that has completed, run by Otonomy. The registered enrollment target is 153 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04829214, a Phase 2 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.
Primary Outcome
The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus. A responder is considered as any subject with at least a 13-point improvement from Baseline on the (TFI). This responder analysis required both Week 4 and Week 8 to have a 13-point improvement from Baseline.
Interventions
- DRUG Placebo
- DRUG OTO-313
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 2 |
What the finished NCT04829214 record still lists
NCT04829214 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04829214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04829214 about?
NCT04829214 is a clinical study titled "OTO-313 in Subjects With Unilateral Subjective Tinnitus". The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.
What is the current status of trial NCT04829214?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2021-03-22. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT04829214?
The interventions under investigation include: Placebo (DRUG), OTO-313 (DRUG).
Who is sponsoring clinical trial NCT04829214?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04829214's enrollment target sits among peer trials
153 449th of 2000 higher than 1,549 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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