Trials / Completed
CompletedNCT02257983
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Edison Pharmaceuticals Inc · Industry
- Sex
- All
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Accepted
Summary
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-10-31
- Primary completion
- 2015-11-30
- Completion
- 2016-02-29
- First posted
- 2014-10-07
- Last updated
- 2020-11-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02257983. Inclusion in this directory is not an endorsement.