Meniere's Disease Clinical Trial
Official title:
A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension
Verified date | August 2017 |
Source | Otonomy, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.
Status | Completed |
Enrollment | 128 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria includes, but is not limited to: - Subject has a diagnosis of definite unilateral Meniere's disease. - Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study. Exclusion Criteria includes, but is not limited to: - Subject is pregnant or lactating. - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Otonomy, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Otoscopy, audiometry, tympanometry, adverse events | Up to 1 Year | |
Secondary | Meniere's Symptom Questionnaire | Up to 1 Year |
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