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

NCT03664674 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2022-12-07

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Conditions

  • Meniere Disease

Interventions

DRUG

OTO-104

Single intratympanic injection of 12 mg dexamethasone

DRUG

Placebo

Single intratympanic injection of placebo

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2020-12-22
Completion
2020-12-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03664674 on ClinicalTrials.gov