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Phase 3 Study of OTO-104 in Subjects With Unilateral 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664674
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Tracking Information
First Submitted Date  ICMJE August 31, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE August 27, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
The number of definitive vertigo days [ Time Frame: 3 months ]
subject diary
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03664674 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Audiometry [ Time Frame: 3 months ]
    assessment of hearing function
  • Otoscopic examination - use of an otoscope to assess the health of the ear [ Time Frame: 3 months ]
    assessment of the auditory canal and tympanic membrane
  • Adverse events [ Time Frame: 3 months ]
    medical events reported by the subject
  • Impact of vertigo experience on daily activities [ Time Frame: 3 Months ]
    subject diary
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 Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Official Title  ICMJE A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety 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
Intervention Model Description:
Randomized, Double-blind, Placebo-controlled, Multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Meniere Disease
Intervention  ICMJE
  • Drug: OTO-104
    Single intratympanic injection of 12 mg dexamethasone
  • Drug: Placebo
    Single intratympanic injection of placebo
Study Arms  ICMJE
  • Experimental: OTO-104
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
  • Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
  • Subject has a history of vestibular migraine.
  • Subject has used an investigational drug or device in the 3 months prior to screening.
  • Subject has previously been randomized to a clinical study of OTO-104.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Study Manager otonomyclinicaltrials@otonomy.com
Listed Location Countries  ICMJE Belgium,   Germany,   Italy,   Poland,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03664674
Other Study ID Numbers  ICMJE 104-201811
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Otonomy, Inc.
Study Sponsor  ICMJE Otonomy, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otonomy, Inc.
Verification Date December 2019

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