Trials / Completed
CompletedNCT03918109
OTO-313 in Subjects With Subjective Tinnitus
A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-313 | single intratympanic injection of gacyclidine |
| DRUG | Placebo | single intratympanic injection of placebo |
Timeline
- Start date
- 2019-04-04
- Primary completion
- 2020-05-29
- Completion
- 2020-05-29
- First posted
- 2019-04-17
- Last updated
- 2022-12-23
- Results posted
- 2022-12-23
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03918109. Inclusion in this directory is not an endorsement.