Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02740387
Recruitment Status : Terminated (Negative Efficacy Results from the recently completed Phase 3 study 104-201506)
First Posted : April 15, 2016
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

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.

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: OTO-104 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OTO-104
12 mg dexamethasone
Drug: OTO-104
Other Name: Single intratympanic injection 12 mg OTO-104




Primary Outcome Measures :
  1. Evaluation of adverse events as a measure of safety and tolerability [ Time Frame: Up to 1 Year ]

Secondary Outcome Measures :
  1. Change in hearing from baseline as assessed by audiometry [ Time Frame: Up to 1 Year ]
  2. Changes in patient condition assessed by otoscopy [ Time Frame: Up to 1 Year ]
  3. Changes in patient condition assessed by tympanometry [ Time Frame: Up to 1 Year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740387


Locations
Layout table for location information
Canada, Ontario
Call Otonomy call center for trial locations
London, Ontario, Canada
Sponsors and Collaborators
Otonomy, Inc.
Investigators
Layout table for investigator information
Study Chair: Kathie Bishop, PhD Otonomy, Inc.
Layout table for additonal information
Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02740387    
Other Study ID Numbers: 104-201505
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases