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 November 16, 2022. Link to the current ClinicalTrials.gov record.

Recruitment Status

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

Sponsor

Otonomy, Inc.

Information Provided by (Responsible Party)

Otonomy, Inc.

Clinicaltrials.gov Identifier

NCT02706730
Other Study ID Numbers: 104-201509
First Submitted: March 8, 2016
First Posted: March 11, 2016
Results First Posted: December 14, 2022
Last Update Posted: December 14, 2022
Last Verified: November 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 Enrollment189 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 DateFebruary 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 examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 [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 OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) 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 US. 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