A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
ClinicalTrials.gov processed this data on November 15, 2022. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - 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
NCT03664674Other Study ID Numbers: 104-201811
First Submitted: August 31, 2018
First Posted: September 10, 2018
Results First Posted: December 7, 2022
Last Update Posted: December 7, 2022
Last Verified: November 2022
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 148 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Triple |
| Primary Purpose | Treatment |
| Official Title | A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease |
| Study Start Date | August 27, 2018 |
| Actual Primary Completion Date | December 22, 2020 |
| Actual Study Completion Date | December 22, 2020 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 28-Day Average DVD at Week 12 (Month 3) [3 months] The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28.
Secondary Outcome Measures
- Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden [3 Months] The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries.
- Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit [3 months] Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit.
- Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) [Week 12 (Month 3)] The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 1000 Hz.
- Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) [Week 12 (Month 3)] The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 2000 Hz.
- Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) [Week 12 (Month 3)] The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 4000 Hz.
Eligibility Criteria
| Ages Eligible for Study | 18 Years to 85 Years (Adult, Older Adult) |
|---|---|
| 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. |
|---|---|
| Locations |
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Study Documents (Full Text)
- Documents Provided by Otonomy, Inc.: Study Protocol and Statistical Analysis Plan July 30, 2020
More Information
Additional Relevant MeSH Terms
- Meniere Disease
- Endolymphatic Hydrops
- Labyrinth Diseases
- Ear Diseases
- Otorhinolaryngologic Diseases