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A 6-Month Extension Study of OTO-104 in 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: NCT02706730
Recruitment Status : Terminated (Negative Efficacy Results from the recently completed Phase 3 study 104-201506)
First Posted : March 11, 2016
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: OTO-104 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OTO-104
12 mg dexamethasone
 Drug: OTO-104
Single intratympanic injection of 12 mg OTO-104


Outcome Measures
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Primary Outcome Measures :
  1. Safety as assessed by adverse events [ Time Frame: 6 Months ]
    Evaluation of adverse events

  2. Safety as assessed by otoscopic exams [ Time Frame: 6 Months ]
    Evaluation of otoscopic exams


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT02706730


Locations
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United States, California
Many sites in US. Refer to the contact info listed below.
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
Investigators
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Study Chair: Kathie Bishop, PhD Otonomy, Inc.
More Information
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02706730    
Other Study ID Numbers: 104-201509
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases