Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss

Phase 1

Completed

• Conditions: Ear Diseases; Hearing Loss; Hearing Disorders; Deafness; Hearing Loss, Sensorineural
• Interventions: Drug: Saline solution; Drug: Ancrod

• Registration Number: NCT01621256
• Lead Sponsor: Nordmark Arzneimittel GmbH & Co. KG

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-18
• Study Start: 2013-05
• Primary Completion: 2018-09-18
• Study Completion: 2018-10-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline solution	Saline solution	Saline solution
Ancrod	Ancrod	Ancrod

Primary Outcome Measures

Name	Time	Method
Change in PTA (pure tone audiogram) in the affected ear	From baseline to Day 8

Secondary Outcome Measures

Name	Time	Method
Change in speech recognition in the affected ear	From baseline to Day 8

Trial Locations

Locations (2)

Site CZ; 🇨🇿 Praha, Czechia

Site D; 🇩🇪 München, Germany