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

NCT ID: NCT02706730

Last Updated: 2022-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Meniere's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OTO-104

12 mg dexamethasone

Group Type EXPERIMENTAL

OTO-104

Intervention Type DRUG

Single intratympanic injection of 12 mg OTO-104

Interventions

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OTO-104

Single intratympanic injection of 12 mg OTO-104

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otonomy, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathie Bishop, PhD

Role: STUDY_CHAIR

Otonomy, Inc.

Locations

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

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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104-201509

Identifier Type: -

Identifier Source: org_study_id