A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
NCT ID: NCT02265393
Last Updated: 2017-08-18
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
PHASE2
128 participants
INTERVENTIONAL
2014-10-31
2016-05-31
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
DOUBLE
Study Groups
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OTO-104
12 mg OTO-104 (dexamethasone)
OTO-104
Placebo
OTO-104 vehicle
Placebo
Interventions
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OTO-104
Placebo
Eligibility Criteria
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Inclusion Criteria
* Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.
Exclusion Criteria
* Subject has a history of immunodeficiency disease.
* Subject has a history of previous endolymphatic sac surgery.
* Subject has a history of previous use of intratympanic gentamicin in the affected ear.
* Subject has a history of drop attacks.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.
18 Years
80 Years
ALL
No
Sponsors
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Otonomy, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carl LeBel, PhD
Role: STUDY_CHAIR
Otonomy, Inc.
Locations
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Heatherwood & Wexham Park Hospitals
Berkshire, , United Kingdom
Birmingham University Hospital
Birmingham, , United Kingdom
BMI The Edgbaston Hospital
Birmingham, , United Kingdom
Southmead Hospital Bristol
Bristol, , United Kingdom
Oxford University Hospitals
Bucks, , United Kingdom
Cambridge University Hospitals
Cambridge, , United Kingdom
Dorset County Hospital
Dorset, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Leicester Royal Infirmary
Leicestershire, , United Kingdom
Guy's Hospital and St. Thomas' Hospital
London, , United Kingdom
St. George Hospital
London, , United Kingdom
Norfolk & Norwich University Hospital
Norfolk, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Sheffield Teaching Hospitals & Sheffield Children's Hospital
Sheffield, , United Kingdom
University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital
Staffordshire, , United Kingdom
Countries
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Other Identifiers
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104-201403
Identifier Type: -
Identifier Source: org_study_id
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