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NCT01444846 · ClinicalTrials.gov registry record · Phase 2
Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
A Phase 2 study, sponsored by Sound Pharmaceuticals, Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT01444846 is a Phase 2 study that has completed, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 83 participants.
The verdict
NCT01444846, a Phase 2 study, has completed, sponsored by Sound Pharmaceuticals, Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music player. We will measure temporary changes in hearing in subjects who listen to music and take either the study drug, SPI-1005, or a placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.
Interventions
- DRUG Placebo
- DRUG SPI-1005 Low dose
- DRUG SPI-1005 Middle dose
- DRUG SPI-1005 High dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01444846
The ClinicalTrials.gov registry entry for NCT01444846 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 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.
NCT01444846 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01444846 about?
NCT01444846 is a clinical study titled "Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift". Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music player. We will measure temporary changes in hearing in subjects who listen...
What is the current status of trial NCT01444846?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2011-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01444846?
The interventions under investigation include: Placebo (DRUG), SPI-1005 Low dose (DRUG), SPI-1005 Middle dose (DRUG), SPI-1005 High dose (DRUG).
Who is sponsoring clinical trial NCT01444846?
This trial is sponsored by Sound Pharmaceuticals, Incorporated, which has 9 total clinical trials registered on ClinicalTrials.gov.
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