Open Label Study of OTO-104 in Subjects With Meniere's Di... | NCT02740387

Studies
Open Label Study of OTO-104 in Subjects With Meniere's Disease

NCT02740387

Sponsor

Otonomy, Inc.

Status

Terminated

Last Update Posted

Sep 15, 2017Actual

Enrollment

34Actual

Phase

Phase 2

Conditions

Meniere's Disease

Interventions

OTO-104

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Negative Efficacy Results from the recently completed Phase 3 study 104-201506

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Mar 25, 2016

First Submission Date that Met QC Criteria

Apr 11, 2016

First Posted Date

Apr 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2017

Last Update Posted Date

Sep 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OTO-104	Experimental	12 mg dexamethasone	Drug: OTO-104

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OTO-104	Drug		OTO-104	Single intratympanic injection 12 mg OTO-104

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of adverse events as a measure of safety and tolerability		Up to 1 Year

Secondary Outcomes

Measure	Description	Time Frame
Change in hearing from baseline as assessed by audiometry		Up to 1 Year
Changes in patient condition assessed by otoscopy		Up to 1 Year
Changes in patient condition assessed by tympanometry

Other Outcomes

Not provided

Eligibility Module

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 has an infection in the ear, sinuses, or upper respiratory system.
Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
Subject has experienced an adverse reaction to intratympanic injection of steroids.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathie Bishop, PhD	Otonomy, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Call Otonomy call center for trial locations		London	Ontario		Canada

Type	Date	Date Unknown
Release	Oct 24, 2022
Reset	Sep 5, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 24, 2022			Sep 5, 2023

Condition Browse Module

MeSH Terms

ID	Term
D008575	Meniere Disease

Ancestor Terms

ID	Term
D018159	Endolymphatic Hydrops
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069555	Injection, Intratympanic

Ancestor Terms

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided