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

PHASE2CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

March 31, 2014

Conditions
Temporary Auditory Threshold Shift
Interventions
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

Trial Locations (1)

32610

University of Florida, Gainsville

All Listed Sponsors
collaborator

University of Florida

OTHER

lead

Sound Pharmaceuticals, Incorporated

INDUSTRY

NCT01444846 - Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift | Biotech Hunter | Biotech Hunter