Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2010-03-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OTO-104 (steroid) 3 mg
OTO-104 (steroid) 3 mg
OTO-104 3 mg dose cohort, single intratympanic injection.
Placebo
Placebo
Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
OTO-104 (steroid) 12 mg
The start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.
OTO-104 (steroid) 12 mg
Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.
Interventions
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OTO-104 (steroid) 3 mg
OTO-104 3 mg dose cohort, single intratympanic injection.
Placebo
Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
OTO-104 (steroid) 12 mg
Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.
Eligibility Criteria
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Inclusion Criteria
2. Subject has experienced active vertigo during the lead-in period.
3. Subject has asymmetric low frequency sensorineural hearing loss.
4. Subject agrees to maintain their current treatments for Meniere's disease while on-study.
5. Subjects not currently on a low-salt diet or diuretic should have a medical history of having used one or both of these treatments for at least 1 month without relief of symptoms.
6. Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.
Exclusion Criteria
2. Subject is pregnant or lactating.
3. Subject has a history of immunodeficiency disease.
4. Subject has a history of previous endolymphatic sac surgery.
5. Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
6. Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
7. Subject has experienced an adverse reaction to IT injection of steroids.
8. Subject has used an investigational drug or device in the 3 months prior to screening.
9. Subject has had a duration of Meniere's disease of \>20 years.
18 Years
75 Years
ALL
No
Sponsors
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Otonomy, Inc.
INDUSTRY
Responsible Party
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Otonomy, Inc
Principal Investigators
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Carl LeBel, PhD
Role: STUDY_CHAIR
Otonomy, Inc.
Locations
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House Ear Institute
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
Colorado Otolaryngology Associates
Colorado Springs, Colorado, United States
Silverstein Institute
Sarasota, Florida, United States
Northwestern University, Feinberg School of Medicine, Otolaryngology
Chicago, Illinois, United States
Mass Eye & Ear Infirmary
Boston, Massachusetts, United States
University of Michigan Hospitals, Dept. of Otolaryngology
Ann Arbor, Michigan, United States
Michigan Ear Institute
Farmington Hills, Michigan, United States
St Louis University
St Louis, Missouri, United States
New York Eye and Ear Infirmary
New York, New York, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Wilmington Medical Research
Wilmington, North Carolina, United States
Piedmont Medical Research
Winston-Salem, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University Of Texas, Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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104-200901
Identifier Type: -
Identifier Source: org_study_id
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