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
ClinicalTrials.gov processed this data on December 28, 2022. Link to the current ClinicalTrials.gov record.Recruitment Status
TERMINATED - HAS RESULTS(See Contacts and Locations)
Verified December 2022 by Otonomy, Inc.
Sponsor
Otonomy, Inc.Information Provided by (Responsible Party)
Otonomy, Inc.Clinicaltrials.gov Identifier
NCT02768662Other Study ID Numbers: 104-201610
First Submitted: May 9, 2016
First Posted: May 11, 2016
Results First Posted: January 20, 2023
Last Update Posted: January 20, 2023
Last Verified: December 2022
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 142 participants |
Design Allocation | N/A |
Interventional Model | Single Group Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
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 |
Study Start Date | August 2016 |
Actual Primary Completion Date | September 2017 |
Actual Study Completion Date | September 2017 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) [6 Months] Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Otonomy, Inc. |
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Locations |
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Investigators |
Study Documents (Full Text)
- Documents Provided by Otonomy, Inc.: Study Protocol and Statistical Analysis Plan April 26, 2016
More Information
Additional Relevant MeSH Terms
- Meniere Disease
- Endolymphatic Hydrops
- Labyrinth Diseases
- Ear Diseases
- Otorhinolaryngologic Diseases