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Study of OTO-104 in Subjects With Unilateral Meniere's Disease (AVERTS-2)

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: NCT02717442
Recruitment Status : Terminated (Negative Efficacy Results from the recently completed Phase 3 study 104-201506)
First Posted : March 23, 2016
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Actual Study Start Date : March 21, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : September 15, 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
Placebo Comparator: Placebo Drug: Placebo
Single intratympanic injection of placebo


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in number of definitive vertigo days compared to placebo as assessed by a daily diary [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in hearing from baseline as assessed by audiometry [ Time Frame: 3 months ]
  2. Change in the condition of the ear from baseline as assessed by otoscopic examinations [ Time Frame: 3 months ]
  3. Evaluation of adverse events as a measure of safety and tolerability [ Time Frame: 3 months ]
  4. Impact of vertigo experience on daily activities [ Time Frame: 3 months ]
    Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 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 unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
  • Subject has experienced active vertigo during the lead-in period.
  • Subject has documented asymmetric sensorineural hearing loss.
  • Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has a history of previous endolymphatic sac surgery.
  • Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
  • Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
  • Subject has experienced an adverse reaction to IT injection of steroids.
  • Subject has used an investigational drug or device in the 3 months prior to screening.
  • Subject has previously been randomized to a trial of OTO-104.
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): NCT02717442


Locations
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United States, California
Many sites in Europe. 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: NCT02717442    
Other Study ID Numbers: 104-201508
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Keywords provided by Otonomy, Inc.:
Meniere's Disease
Vertigo
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases