Trials / Completed
CompletedNCT02265393
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-104 | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2014-10-15
- Last updated
- 2017-08-18
Locations
15 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02265393. Inclusion in this directory is not an endorsement.