At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 148 enrolled
Drug / intervention
OTO-104 +1 moredrug
Likely dose
OTO-104 12 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating OTO-104 and Placebo for Meniere Disease. Completed, enrolled 148 participants across 65 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeniere Disease
CountriesBelgium, Germany, Italy, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartAug 2018
First PostedSep 2018
Primary CompletionDec 2020
TodayJul 2026
First PostedSep 10, 2018
Enrollment StartAug 27, 2018
Primary CompletionDec 22, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.8 years ago
Interventions
OTO-104drug
Single intratympanic injection of 12 mg dexamethasone
Placebodrug
Single intratympanic injection of placebo