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

NCT01444846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2014-08-28

No results posted yet for this 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.

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

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • Sound Pharmaceuticals, Incorporated

    lead INDUSTRY

Principal Investigators

  • Colleen Le Prell, PhD · University of Florida

  • Jonathan Kil, MD · Sound Pharmaceuticals, Inc

  • Eric D Lynch, PhD · Sound Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
31 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • United States

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01444846 on ClinicalTrials.gov