Clinical trial NCT02265393: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meniere's Disease
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety
timeFrame: Up to 1 Year
Secondary outcomes:
measure: Meniere's Symptom Questionnaire
timeFrame: Up to 1 Year
Other outcomes:
Locations:
city: Berkshire
country: United Kingdom
facility: Heatherwood & Wexham Park Hospitals
city: Birmingham
country: United Kingdom
facility: Birmingham University Hospital
city: Birmingham
country: United Kingdom
facility: BMI The Edgbaston Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
city: Bucks
country: United Kingdom
facility: Oxford University Hospitals
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals
city: Dorset
country: United Kingdom
facility: Dorset County Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Leicestershire
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Guy's Hospital and St. Thomas' Hospital
city: London
country: United Kingdom
facility: St. George Hospital
city: Norfolk
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals & Sheffield Children's Hospital
city: Staffordshire
country: United Kingdom
facility: University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References: