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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: Recruiting Phase 2 study of Ototoxicity, Drug-Induced, sponsored by Kevin Winthrop.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Outcome is measured by changes from baseline using the American Speech-Language-Hearing Association (ASHA) shift criterion in patients with NTM disease undergoing treatment with IV amikacin therapy
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 |
What NCT05730283 shows while recruiting
NCT05730283 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05730283's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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