Trials / Completed
CompletedNCT04829214
OTO-313 in Subjects With Unilateral Subjective Tinnitus
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-313 | Single intratympanic injection |
| DRUG | Placebo | Single intratympanic injection |
Timeline
- Start date
- 2021-03-22
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2021-04-02
- Last updated
- 2023-01-06
- Results posted
- 2023-01-06
Locations
48 sites across 4 countries: United States, Germany, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04829214. Inclusion in this directory is not an endorsement.