Back to resultsA 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
OTO-104
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease
Eligibility Criteria
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.
Sites / Locations
- Heatherwood & Wexham Park Hospitals
- Birmingham University Hospital
- BMI The Edgbaston Hospital
- Southmead Hospital Bristol
- Oxford University Hospitals
- Cambridge University Hospitals
- Dorset County Hospital
- Gloucestershire Royal Hospital
- Leicester Royal Infirmary
- Guy's Hospital and St. Thomas' Hospital
- St. George Hospital
- Norfolk & Norwich University Hospital
- John Radcliffe Hospital
- Sheffield Teaching Hospitals & Sheffield Children's Hospital
- University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
OTO-104
Placebo
Arm Description
12 mg OTO-104 (dexamethasone)
OTO-104 vehicle
Outcomes
Primary Outcome Measures
Safety
Otoscopy, audiometry, tympanometry, adverse events
Secondary Outcome Measures
Meniere's Symptom Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02265393
Brief Title
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-104
Arm Type
Active Comparator
Arm Description
12 mg OTO-104 (dexamethasone)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
OTO-104 vehicle
Intervention Type
Drug
Intervention Name(s)
OTO-104
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety
Description
Otoscopy, audiometry, tympanometry, adverse events
Time Frame
Up to 1 Year
Secondary Outcome Measure Information:
Title
Meniere's Symptom Questionnaire
Time Frame
Up to 1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl LeBel, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Heatherwood & Wexham Park Hospitals
City
Berkshire
Country
United Kingdom
Facility Name
Birmingham University Hospital
City
Birmingham
Country
United Kingdom
Facility Name
BMI The Edgbaston Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Southmead Hospital Bristol
City
Bristol
Country
United Kingdom
Facility Name
Oxford University Hospitals
City
Bucks
Country
United Kingdom
Facility Name
Cambridge University Hospitals
City
Cambridge
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorset
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicestershire
Country
United Kingdom
Facility Name
Guy's Hospital and St. Thomas' Hospital
City
London
Country
United Kingdom
Facility Name
St. George Hospital
City
London
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norfolk
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals & Sheffield Children's Hospital
City
Sheffield
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital
City
Staffordshire
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
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