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

ClinicalTrials.gov processed this data on December 28, 2022. Link to the current ClinicalTrials.gov record.

Recruitment Status

TERMINATED - HAS RESULTS
(See Contacts and Locations)
Verified December 2022 by Otonomy, Inc.

Sponsor

Otonomy, Inc.

Information Provided by (Responsible Party)

Otonomy, Inc.

Clinicaltrials.gov Identifier

NCT02768662
Other Study ID Numbers: 104-201610
First Submitted: May 9, 2016
First Posted: May 11, 2016
Results First Posted: January 20, 2023
Last Update Posted: January 20, 2023
Last Verified: December 2022
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Meniere's Disease
  • Drug: OTO-104

Study Design

Study TypeInterventional
Actual Enrollment142 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateAugust 2016
Actual Primary Completion DateSeptember 2017
Actual Study Completion DateSeptember 2017

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • OTO-104
    • 12 mg dexamethasone
  • Drug: OTO-104
    • Single intratympanic injection of 12 mg OTO-104

Outcome Measures

Primary Outcome Measures

  1. Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) [6 Months]
    Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).

Eligibility Criteria

Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
Inclusion Criteria
  • cludes, but is not limited to:
  • Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
  • Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria
Exclusion Criteria
  • cludes, 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

Sponsors and Collaborators Otonomy, Inc.
Locations
  • Many sites in Europe. Refer to the contact info listed below. | San Diego, California, United States, 92121
Investigators

    Study Documents (Full Text)

    More Information

    Additional Relevant MeSH Terms

    • Meniere Disease
    • Endolymphatic Hydrops
    • Labyrinth Diseases
    • Ear Diseases
    • Otorhinolaryngologic Diseases