NCT01444846

Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift

Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Sound Pharmaceuticals, Incorporated · Industry
• Sex: All
• Age: 18 Years – 31 Years
• Healthy volunteers: Accepted

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.

Conditions

• Temporary Auditory Threshold Shift

Interventions

Type	Name	Description
DRUG	SPI-1005 Low dose	Oral capsules, 200 mg ebselen, twice daily, 4 days
DRUG	SPI-1005 Middle dose	Oral capsules, 400 mg ebselen, twice daily, 4 days
DRUG	SPI-1005 High dose	Oral capsules, 600 mg ebselen, twice daily, 4 days
DRUG	Placebo	Oral capsules, 0 mg ebselen, twice daily, 4 days

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2011-10-03
• Last updated: 2014-08-28

Locations

1 site across 1 country: United States