Protective Effects of EPI-743 on Noise-Induced Hearing Loss
NCT ID: NCT02257983
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2014-10-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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EPI-743
EPI-743 400 mg P.O. TID
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.
Placebo
Sesame Oil, NF in sealed gelatin capsules to match the test product
Placebo
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Interventions
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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.
Placebo
2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30 days prior to treatment initiation
* Non-smokers
* Abstention from alcohol from day 0 and throughout the duration of study
* Normal audiology exam
* Subject must be able to swallow size 0 capsules
Exclusion Criteria
* Any medical disordere that would prevent subject participation
* Any prescription meds other than for contraception or seasonal allergies
* Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, ADHD, hx. of migraines, neurological, kidney)
* Fat malabsorption syndromes
* Anticoagulation thereapy within 30 days of enrollment
18 Years
30 Years
ALL
Yes
Sponsors
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Edison Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Colleen Le Prell, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Related Links
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Related Info
Other Identifiers
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EPI743-14-026
Identifier Type: -
Identifier Source: org_study_id