Status and phase
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About
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.
Full 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).
Enrollment
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Inclusion criteria
Other protocol-defined inclusion criteria may apply.
Exclusion criteria
Other protocol-defined exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
893 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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