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Protective Effects of EPI-743 on Noise-Induced Hearing Loss

NCT02257983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-11-18

No results posted yet for this study

Summary

If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.

Conditions

  • Noise-induced Hearing Loss

Interventions

DRUG

EPI-743

EPI-743 (2 capsules 200 mg each) taken at a dose of 400 mg P.O. TID for 9 days with noise exposure for 4 hours on Day 8.

DRUG

Placebo

2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.

Sponsors & Collaborators

  • Edison Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Colleen Le Prell, Ph.D · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-11-30
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

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 NCT02257983 on ClinicalTrials.gov