Clinical Trial: Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)
Brief Summary: The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
Detailed Summary:
Sponsor: Nordmark Arzneimittel GmbH & Co. KG
Current Primary Outcome: Change in PTA (pure tone audiogram) in the affected ear [ Time Frame: From baseline to Day 8 ]
Original Primary Outcome: The primary outcome measure for this study is the change in PTA (pure tone audiogram) in the affected ear [ Time Frame: From baseline until Day 8 ]
Current Secondary Outcome: Change in speech recognition in the affected ear [ Time Frame: From baseline to Day 8 ]
Original Secondary Outcome: Change in speech recognition in the affected ear [ Time Frame: From baseline until Day 8 ]
Information By: Nordmark Arzneimittel GmbH & Co. KG
Dates:
Date Received: June 12, 2012
Date Started: May 2013
Date Completion: October 2017
Last Updated: February 27, 2017
Last Verified: February 2017