At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 166 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 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's Disease. Completed, enrolled 166 participants across 1 site.
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's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedNov 2015
Primary CompletionJul 2017
TodayJul 2026
First PostedNov 23, 2015
Enrollment StartOct 27, 2015
Primary CompletionJul 18, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.6 years ago
Interventions
OTO-104drug
Single intratympanic injection of 12 mg OTO-104
Placebodrug
Single intratympanic injection of placebo