Clinical Trial: Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
Brief Summary: The purpose of the study is to determine whether AM-111 is effective in the treatment of acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).
Detailed Summary:
Sponsor: Auris Medical AG
Current Primary Outcome: Hearing loss [ Time Frame: 7 days ]
Original Primary Outcome: Average change in hearing loss in dB between the baseline and D7 for the three contiguous frequencies with the worst hearing loss, identified at study entry [ Time Frame: 7 days ]
Current Secondary Outcome: Hearing loss [ Time Frame: Days 3, 30, 90 ]
Original Secondary Outcome: Average change in hearing loss in dB between the baseline and D3, D30, and D90 for the three contiguous frequencies with the worst hearing loss, identified at study entry [ Time Frame: Days 3, 30, 90 ]
Information By: Auris Medical, Inc.
Dates:
Date Received: December 3, 2008
Date Started: December 2008
Date Completion:
Last Updated: June 24, 2014
Last Verified: June 2014