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 November 16, 2022. Link to the current ClinicalTrials.gov record.Recruitment Status
TERMINATED - HAS RESULTS(See Contacts and Locations)
Verified November 2022 by Otonomy, Inc.
Sponsor
Otonomy, Inc.Information Provided by (Responsible Party)
Otonomy, Inc.Clinicaltrials.gov Identifier
NCT02706730Other Study ID Numbers: 104-201509
First Submitted: March 8, 2016
First Posted: March 11, 2016
Results First Posted: December 14, 2022
Last Update Posted: December 14, 2022
Last Verified: November 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 | 189 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 | February 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 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]).
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 February 22, 2016
More Information
Additional Relevant MeSH Terms
- Meniere Disease
- Endolymphatic Hydrops
- Labyrinth Diseases
- Ear Diseases
- Otorhinolaryngologic Diseases