Trials / Completed
CompletedNCT03664674
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-104 | Single intratympanic injection of 12 mg dexamethasone |
| DRUG | Placebo | Single intratympanic injection of placebo |
Timeline
- Start date
- 2018-08-27
- Primary completion
- 2020-12-22
- Completion
- 2020-12-22
- First posted
- 2018-09-10
- Last updated
- 2022-12-07
- Results posted
- 2022-12-07
Locations
65 sites across 8 countries: United States, Belgium, Germany, Italy, Poland, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03664674. Inclusion in this directory is not an endorsement.