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Study of OTO-104 in Subjects With Unilateral Meniere's Disease (AVERTS-1)

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: NCT02612337
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE November 23, 2015
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE October 27, 2015
Actual Primary Completion Date July 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
Reduction in number of definitive vertigo days compared to placebo [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • Audiometry [ Time Frame: 3 months ]
  • Otoscopic examinations [ Time Frame: 3 months ]
  • Evaluation of adverse events as a measure of safety and tolerability [ Time Frame: 3 months ]
  • Impact of vertigo experience on daily activities [ Time Frame: 3 months ]
    Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Meniere's Disease
Intervention  ICMJE
  • Drug: OTO-104
    Single intratympanic injection of 12 mg OTO-104
  • Drug: Placebo
    Single intratympanic injection of placebo
Study Arms  ICMJE
  • Experimental: OTO-104
    12 mg dexamethasone
    Intervention: Drug: OTO-104
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2017)
165
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2015)
160
Actual Study Completion Date  ICMJE July 18, 2017
Actual Primary Completion Date July 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02612337
Other Study ID Numbers  ICMJE 104-201506
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otonomy, Inc.
Study Sponsor  ICMJE Otonomy, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kathie Bishop, PhD Otonomy, Inc.
PRS Account Otonomy, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP