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

December 20, 2018 updated by: Nordmark Arzneimittel GmbH & Co. KG

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

The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hradec Králové, Czechia
        • Site CZ
      • Praha, Czechia
        • Site CZ
  • Germany
      • Göttingen, Germany
        • Site D
      • Hamburg, Germany
        • Site D
      • Hannover, Germany
        • Site D
      • Landsberg am Lech, Germany
        • Site D
      • München, Germany
        • Site D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ancrod
Drug: Ancrod
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Other Names:
  • Viprinex
  • NM-V
Placebo Comparator: Saline solution
Drug: Saline solution
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in PTA (pure tone audiogram) in the affected ear
Time Frame: From baseline to Day 8
From baseline to Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in speech recognition in the affected ear
Time Frame: From baseline to Day 8
From baseline to Day 8

Other Outcome Measures

Outcome Measure
Time Frame
Patient assessment of change in hearing impairment
Time Frame: From baseline to Day 8, Day 30 and Day 90
From baseline to Day 8, Day 30 and Day 90
Change in fibrinogen concentration
Time Frame: From baseline to Day 2 and Day 8
From baseline to Day 2 and Day 8
Change in biomarkers
Time Frame: From baseline to Day 8
From baseline to Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordmark Arzneimittel GmbH & Co. KG

Collaborators

X-act Cologne Clinical Research GmbH
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
ProjectPharm s.r.o.
LCR Leading Clinical Research s.r.o.

Investigators

  • Principal Investigator: Martin Canis, MD PhD, Department for Otorhinolaryngology, LM University Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

September 18, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-V-101
  • 2012-000066-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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