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NCT02819856 · ClinicalTrials.gov registry record · Phase 2
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
A Phase 2 study, sponsored by Sound Pharmaceuticals, Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02819856: Completed Phase 2 study, sponsored by Sound Pharmaceuticals, Incorporated.
NCT02819856 is a Phase 2 study that has completed, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02819856, a Phase 2 study, has completed, sponsored by Sound Pharmaceuticals, Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment. The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics of SPI-1005.
Primary Outcome
Number of participants with ototoxicity: Sensorineural hearing loss using pure-tone audiometry according to the American Speech-Language-Hearing Association (ASHA) criteria for ototoxicity.
Interventions
- DRUG Placebo
- DRUG SPI-1005 Ebselen 200mg Capsule x1
- DRUG SPI-1005 Ebselen 200mg Capsule x2
- DRUG SPI-1005 Ebselen 200mg Capsule x3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2023-04-07 |
| Phase | Phase 2 |
What the finished NCT02819856 record still lists
NCT02819856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02819856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02819856 about?
NCT02819856 is a clinical study titled "SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity". The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Eve...
What is the current status of trial NCT02819856?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-07-21. Estimated completion is 2023-04-07.
What interventions are being tested in trial NCT02819856?
The interventions under investigation include: Placebo (DRUG), SPI-1005 Ebselen 200mg Capsule x1 (DRUG), SPI-1005 Ebselen 200mg Capsule x2 (DRUG), SPI-1005 Ebselen 200mg Capsule x3 (DRUG).
Who is sponsoring clinical trial NCT02819856?
This trial is sponsored by Sound Pharmaceuticals, Incorporated, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02819856's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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