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

Recruitment Status
TERMINATED - HAS RESULTS
(See Contacts and Locations)Verified November 2022 by Otonomy, Inc.
Sponsor
Otonomy, Inc.
Information Provided by (Responsible Party)
Otonomy, Inc.
Clinicaltrials.gov Identifier
NCT02768662
Other Study ID Numbers:
104-201610
First Submitted
May 8, 2016
First Posted
May 10, 2016
Results First Posted
October 19, 2022
Last Update Posted
January 19, 2023
Last Verified
November 2022

ClinicalTrials.gov processed this data on December 2022. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Meniere's Disease
Drug: OTO-104

Study Design

Study TypeInterventional
Actual Enrollment142 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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 Start DateJuly 31, 2016
Actual Primary Completion DateAugust 31, 2017
Actual Study Completion DateAugust 31, 2017

Groups and Cohorts

Group/CohortIntervention/Treatment
OTO-104
12 mg dexamethasone
Drug: OTO-104
Single intratympanic injection of 12 mg OTO-104

Outcome Measures

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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria includes, but is not limited to:
Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria
Exclusion Criteria
Inclusion Criteria includes, but is not limited to:
Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) 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.

Contacts and Locations

Sponsors and CollaboratorsOtonomy, Inc.
Locations
Many sites in Europe. Refer to the contact info listed below. | San Diego California, United States, 92121
Investigators
Study Chair: Kathie Bishop, PhD, Otonomy, Inc.
Study Documents (Full Text)
Documents provided by Otonomy, Inc.: Study Protocol and Statistical Analysis Plan  April 25, 2016