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

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ClinicalTrials.gov Identifier: NCT01621256
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : December 21, 2018
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

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).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : May 2013
Actual Primary Completion Date : September 18, 2018
Actual Study Completion Date : October 30, 2018


Arm Intervention/treatment
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




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

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

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621256


Locations
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Czechia
Site CZ
Hradec Králové, Czechia
Site CZ
Praha, Czechia
Germany
Site D
Göttingen, Germany
Site D
Hamburg, Germany
Site D
Hannover, Germany
Site D
Landsberg am Lech, Germany
Site D
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
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Principal Investigator: Martin Canis, MD PhD Department for Otorhinolaryngology, LM University Munich

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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 )
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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