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NCT03918109 · ClinicalTrials.gov registry record · Phase 1
OTO-313 in Subjects With Subjective Tinnitus
A Phase 1 study, sponsored by Otonomy.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03918109: Completed Phase 1 study, sponsored by Otonomy.
NCT03918109 is a Phase 1 study that has completed, run by Otonomy. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03918109, a Phase 1 study, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.
Primary Outcome
Mean Change from Baseline to End of Study (baseline to Day 29 \[4 weeks after dosing\](Part A) or baseline to Day 57 \[8 weeks after dosing\] (Part B)). in Pure Tone Average Hearing Thresholds; a negative change indicates improvement.
Interventions
- DRUG Placebo
- DRUG OTO-313
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-04-04 |
| Est. Completion | 2020-05-29 |
| Phase | Phase 1 |
What the finished NCT03918109 record still lists
NCT03918109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03918109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03918109 about?
NCT03918109 is a clinical study titled "OTO-313 in Subjects With Subjective Tinnitus". The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.
What is the current status of trial NCT03918109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-04-04. Estimated completion is 2020-05-29.
What interventions are being tested in trial NCT03918109?
The interventions under investigation include: Placebo (DRUG), OTO-313 (DRUG).
Who is sponsoring clinical trial NCT03918109?
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 NCT03918109's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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