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 ]

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


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 ]

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


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