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Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

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ClinicalTrials.gov Identifier: NCT03664674
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : July 17, 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 Disease Drug: OTO-104 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-blind, Placebo-controlled, Multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. The number of definitive vertigo days [ Time Frame: 3 months ]
    subject diary


Secondary Outcome Measures :
  1. Audiometry [ Time Frame: 3 months ]
    assessment of hearing function

  2. 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

  3. Adverse events [ Time Frame: 3 months ]
    medical events reported by the subject

  4. Impact of vertigo experience on daily activities [ Time Frame: 3 Months ]
    subject diary


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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): NCT03664674


Contacts
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Contact: Clinical Study Manager otonomyclinicaltrials@otonomy.com

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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: NCT03664674     History of Changes
Other Study ID Numbers: 104-201811
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Otonomy, Inc.:
Meniere's Disease
Vertigo
Endolymphatic Hydrops
 Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases