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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 is a Phase 2 study that has completed, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02819856
The ClinicalTrials.gov registry entry for NCT02819856 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sound Pharmaceuticals, Incorporated, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02819856 reports 0 study locations.
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.
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