At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 enrolled
Drug / intervention
AM-101 +1 moredrug
Likely dose
Not stated in 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.
Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2
In Brief
A Phase 3 clinical trial evaluating AM-101 and Placebo for Tinnitus. Completed, enrolled 343 participants across 1 site.
Detailed Summary
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartFeb 2014
Primary CompletionJun 2016
TodayJul 2026
First PostedMar 4, 2013
Enrollment StartFeb 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.3 years ago
Interventions
AM-101drug
AM-101 gel for intratympanic injection
Placebodrug
Placebo gel for intratympanic injection