Target- |
Mechanism- |
|
|
|
|
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
Active Org.- |
|
Active Indication- |
|
Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
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
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 amikacin. Participants will take study drug for 90 days or until the end of their amikacin treatment, whichever comes first. During this time, researchers will gather clinical data on the participants' health.
Researchers will compare three groups - two groups taking different doses of the study drug and one group taking a placebo drug - to see if dose of drug has any effect on preventing hearing loss. A placebo is a look-alike substance that contains no active drug.
100 Clinical Results associated with Oricula Therapeutics LLC
0 Patents (Medical) associated with Oricula Therapeutics LLC
100 Deals associated with Oricula Therapeutics LLC
100 Translational Medicine associated with Oricula Therapeutics LLC