A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

August 16, 2017 updated by: Otonomy, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Berkshire, United Kingdom
        • Heatherwood & Wexham Park Hospitals
      • Birmingham, United Kingdom
        • Birmingham University Hospital
      • Birmingham, United Kingdom
        • BMI The Edgbaston Hospital
      • Bristol, United Kingdom
        • Southmead Hospital Bristol
      • Bucks, United Kingdom
        • Oxford University Hospitals
      • Cambridge, United Kingdom
        • Cambridge University Hospitals
      • Dorset, United Kingdom
        • Dorset County Hospital
      • Gloucester, United Kingdom
        • Gloucestershire Royal Hospital
      • Leicestershire, United Kingdom
        • Leicester Royal Infirmary
      • London, United Kingdom
        • Guy's Hospital and St. Thomas' Hospital
      • London, United Kingdom
        • St. George Hospital
      • Norfolk, United Kingdom
        • Norfolk & Norwich University Hospital
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals & Sheffield Children's Hospital
      • Staffordshire, United Kingdom
        • University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OTO-104
12 mg OTO-104 (dexamethasone)
Drug: OTO-104
Placebo Comparator: Placebo
OTO-104 vehicle
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Up to 1 Year
Otoscopy, audiometry, tympanometry, adverse events
Up to 1 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Meniere's Symptom Questionnaire
Time Frame: Up to 1 Year
Up to 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otonomy, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-201403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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