Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
Overview
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
Full Title of Study: “Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 18, 2018
Interventions
- Drug: Ancrod
- Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
- Drug: Saline solution
- Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Arms, Groups and Cohorts
- Experimental: Ancrod
- Ancrod
- Placebo Comparator: Saline solution
- Saline solution
Clinical Trial Outcome Measures
Primary Measures
- Change in PTA (pure tone audiogram) in the affected ear
- Time Frame: From baseline to Day 8
Secondary Measures
- Change in speech recognition in the affected ear
- Time Frame: From baseline to Day 8
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Nordmark Arzneimittel GmbH & Co. KG
- Collaborator
- ClinSupport GmbH
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Martin Canis, MD PhD, Principal Investigator, Department for Otorhinolaryngology, LM University Munich
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