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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
ProjectPharm s.r.o.
LCR Leading Clinical Research s.r.o.
X-act Cologne Clinical Research GmbH
Information provided by (Responsible Party):
Nordmark Arzneimittel GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01621256
First received: June 12, 2012
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).

Condition Intervention Phase
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases Drug: Ancrod Drug: Saline solution Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)

Resource links provided by NLM:


Further study details as provided by Nordmark Arzneimittel GmbH & Co. KG:

Primary Outcome Measures:
  • Change in PTA (pure tone audiogram) in the affected ear [ Time Frame: From baseline to Day 8 ]

Secondary Outcome Measures:
  • Change in speech recognition in the affected ear [ Time Frame: From baseline to Day 8 ]

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

Estimated Enrollment: 115
Study Start Date: May 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ancrod
Ancrod
Drug: Ancrod
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Other Names:
  • Viprinex
  • NM-V
Placebo Comparator: Saline solution
Saline solution
Drug: Saline solution
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621256

Locations
Czechia
Site 2
Hradec Králové, Czechia
Site 1
Praha, Czechia
Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, Germany
Medizinische Hochschule Hannover (MHH)
Hannover, Germany
HNO Zentrum
Landsberg am Lech, Germany
Universitätsmedizin
Mainz, Germany
Klinikum der Universität München (LMU)
München, Germany
Sponsors and Collaborators
Nordmark Arzneimittel GmbH & Co. KG
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
ProjectPharm s.r.o.
LCR Leading Clinical Research s.r.o.
X-act Cologne Clinical Research GmbH
Investigators
Study Director: Kristin Forssmann, MD Nordmark Arzneimittel GmbH & Co. KG
Principal Investigator: Martin Canis, MD PhD Department for Otolaryngology, University Göttingen Medical Center
  More Information

Responsible Party: Nordmark Arzneimittel GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01621256     History of Changes
Other Study ID Numbers: NM-V-101
2012-000066-37 ( EudraCT Number )
Study First Received: June 12, 2012
Last Updated: June 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Ear Diseases
Hearing Loss
Deafness
Hearing Disorders
Hearing Loss, Sensorineural
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharmaceutical Solutions
Ancrod
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017