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A 6-Month Extension Study of OTO-104 in Meniere's Disease

NCT02768662 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-01-20

Study results available
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Summary

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.

Conditions

  • Meniere's Disease

Interventions

DRUG

OTO-104

Single intratympanic injection of 12 mg OTO-104

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Principal Investigators

  • Kathie Bishop, PhD · Otonomy, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02768662 on ClinicalTrials.gov