A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
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
1 other identifier
interventional
128
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2014
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 9, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedAugust 18, 2017
August 1, 2017
1.6 years
October 9, 2014
August 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Otoscopy, audiometry, tympanometry, adverse events
Up to 1 Year
Secondary Outcomes (1)
Meniere's Symptom Questionnaire
Up to 1 Year
Study Arms (2)
OTO-104
ACTIVE COMPARATOR12 mg OTO-104 (dexamethasone)
Placebo
PLACEBO COMPARATOROTO-104 vehicle
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otonomy, Inc.lead
Study Sites (15)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carl LeBel, PhD
Otonomy, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2014
First Posted
October 15, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
August 18, 2017
Record last verified: 2017-08