Trials / Terminated
TerminatedNCT02768662
A 6-Month Extension Study of OTO-104 in Meniere's Disease
A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-104 | Single intratympanic injection of 12 mg OTO-104 |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-09-01
- Completion
- 2017-09-01
- First posted
- 2016-05-11
- Last updated
- 2023-01-20
- Results posted
- 2023-01-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02768662. Inclusion in this directory is not an endorsement.