Meniere's Disease Clinical Trial
Official title:
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
Verified date | November 2022 |
Source | Otonomy, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.
Status | Terminated |
Enrollment | 189 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria includes, but is not limited to: - Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study. - Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria Exclusion Criteria includes, but is not limited to: - Subject is pregnant or lactating. - Subject has a history of immunodeficiency disease. - Subject has experienced an adverse reaction to intratympanic injection of steroids. |
Country | Name | City | State |
---|---|---|---|
United States | Many sites in US. Refer to the contact info listed below. | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Otonomy, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 [Month 6]). | 6 Months |
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