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A 6-Month Extension Study of OTO-104 in Meniere's Disease

Primary Purpose

Meniere's Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OTO-104
Sponsored by
Otonomy, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria includes, but is not limited to:

  • Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study.
  • Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has experienced an adverse reaction to intratympanic injection of steroids.

Sites / Locations

  • Many sites in US. Refer to the contact info listed below.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OTO-104

Arm Description

12 mg dexamethasone

Outcomes

Primary Outcome Measures

Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 [Month 6]).

Secondary Outcome Measures

Full Information

First Posted
March 8, 2016
Last Updated
November 16, 2022
Sponsor
Otonomy, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02706730
Brief Title
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Official Title
A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Study Start Date
February 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTO-104
Arm Type
Experimental
Arm Description
12 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
OTO-104
Intervention Description
Single intratympanic injection of 12 mg OTO-104
Primary Outcome Measure Information:
Title
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Description
Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 [Month 6]).
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria includes, but is not limited to: Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study. Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria Exclusion Criteria includes, but is not limited to: Subject is pregnant or lactating. Subject has a history of immunodeficiency disease. Subject has experienced an adverse reaction to intratympanic injection of steroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathie Bishop, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Many sites in US. Refer to the contact info listed below.
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A 6-Month Extension Study of OTO-104 in Meniere's Disease

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