Trial | NCT01621256  Report issue

Title

Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    31
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
Study Started
May 31
2013
Primary Completion
Sep 18
2018
Study Completion
Oct 30
2018
Last Update
Dec 21
2018

Drug Ancrod

Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

  • Other names: Viprinex, NM-V

Drug Saline solution

Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

  • Other names: Placebo

Ancrod Experimental

Ancrod

Saline solution Placebo Comparator

Saline solution

Criteria 

Inclusion Criteria:

Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
Symmetric hearing prior to onset of SSHL
Enrollment has to be accomplished within 7 days after SSHL onset

Exclusion Criteria:

Bilateral SSHL
Incomplete recovery after previous SSHL
Previously existing, known retrocochlear hearing loss
Any history of any ear operation or local inflammatory disease in the past one year
History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
Treatment with steroids for any reason within the preceding 30 days.
Body weight > 140 kg
No Results Posted