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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: Completed Phase 2 study, sponsored by Sound Pharmaceuticals, Incorporated.
NCT01444846 is a Phase 2 study that has completed, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy analysis was change in air conduction threshold at 4 kHz collected in the ITT Population on the day of sound exposure. Baseline hearing thresholds were collected on Clinic Visit 2 prior to sound exposure and used in calculating the primary efficacy endpoints. Hearing thresholds after sound exposure were collected and compared to baseline threshold to calculate change from baseline. Threshold changes from baseline were determined for each ear, frequency, and post sound time p
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 |
What the finished NCT01444846 record still lists
NCT01444846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01444846 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01444846's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 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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