Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
Public ClinicalTrials.gov record NCT05730283. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Therapy for Non-Tuberculous Mycobacterium Disease
Study identification
- NCT ID
- NCT05730283
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Kevin Winthrop
- Other
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Interventions
- ORC-13661 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1, 2025
- Primary completion
- Feb 28, 2028
- Completion
- Feb 28, 2028
- Last update posted
- May 6, 2026
2025 – 2028
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | Recruiting |
| National Jewish Health | Denver | Colorado | 80206 | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | 21224 | Not yet recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Oregon Health & Science University | Portland | Oregon | 97239 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| University of Texas Health Science Center | Tyler | Texas | 75708 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05730283, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05730283 live on ClinicalTrials.gov.