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First received: February 07, 2023

Clinical Trial: Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Ototoxicity, Drug-Induced

Study Type: INTERVENTIONAL


Official Title: Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin for Treatment of Non-Tuberculous Mycobacterium Disease

Brief Summary: The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy.The main question this study aims to answer is:Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment?Is ORC-13661 effective for preventing or lessening other measures of hearing impairment?Participants will be asked to take a study drug while they are being treated with IV…

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