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Clinical Trial 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 or within the last >3 to 6 months.


Clinical Trial Description

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between >3 and 6 months (Stratum B) from onset). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02040194
Study type Interventional
Source Auris Medical, Inc.
Contact
Status Completed
Phase Phase 3
Start date January 2014
Completion date December 28, 2017

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