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NCT05730283 · ClinicalTrials.gov registry record · Phase 2
Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
A Phase 2 study of Ototoxicity, Drug-Induced, sponsored by Kevin Winthrop.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 5
- Study locations
NCT05730283 is a Phase 2 study of Ototoxicity, Drug-Induced that is actively recruiting participants, run by Kevin Winthrop. The registered enrollment target is 105 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT05730283, a Phase 2 study of Ototoxicity, Drug-Induced, is actively recruiting participants, sponsored by Kevin Winthrop.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 5
- Study locations
Study 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 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ORC-13661
Study Locations (5)
Colorado
- National Jewish Health - Denver
Minnesota
- Mayo Clinic - Rochester
Oregon
- Oregon Health & Science University - Portland
South Carolina
- Medical University of South Carolina - Charleston
Texas
- University of Texas Health Science Center - Tyler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2025-06-02 |
| Est. Completion | 2028-02-29 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05730283
The ClinicalTrials.gov registry entry for NCT05730283 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kevin Winthrop, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ototoxicity, Drug-Induced appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05730283 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Minnesota, Oregon.
Frequently Asked Questions
What is clinical trial NCT05730283 about?
NCT05730283 is a clinical study titled "Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin". 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 less...
What is the current status of trial NCT05730283?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2025-06-02. Estimated completion is 2028-02-29.
What conditions does trial NCT05730283 study?
This clinical trial studies the following conditions: Ototoxicity, Drug-Induced.
What interventions are being tested in trial NCT05730283?
The interventions under investigation include: Placebo (DRUG), ORC-13661 (DRUG).
Who is sponsoring clinical trial NCT05730283?
This trial is sponsored by Kevin Winthrop, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05730283 being conducted?
This trial has 5 study locations across Colorado, Minnesota, Oregon, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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