Status:
COMPLETED
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
Lead Sponsor:
Otonomy, Inc.
Conditions:
Meniere's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 inject...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT02265393
Start Date
October 1 2014
End Date
May 1 2016
Last Update
August 18 2017
Active Locations (15)
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1
Heatherwood & Wexham Park Hospitals
Berkshire, United Kingdom
2
Birmingham University Hospital
Birmingham, United Kingdom
3
BMI The Edgbaston Hospital
Birmingham, United Kingdom
4
Southmead Hospital Bristol
Bristol, United Kingdom