Trial record 8 of 628 for:    "Ear Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Nordmark Arzneimittel GmbH & Co. KG
Sponsor:
Collaborators:
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
ProjectPharm s.r.o.
Information provided by (Responsible Party):
Nordmark Arzneimittel GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01621256
First received: June 12, 2012
Last updated: August 22, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in speech recognition in the affected ear [ Time Frame: From baseline to Day 8 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Patient assessment of change in hearing impairment [ Time Frame: From baseline to Day 8, Day 30 and Day 90 ] [ Designated as safety issue: No ]
  • Change in fibrinogen concentration [ Time Frame: From baseline to Day 2 and Day 8 ] [ Designated as safety issue: Yes ]
  • Change in biomarkers [ Time Frame: From baseline to Day 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Cornelia Breuer +49-4122-712-0 cornelia.breuer@nordmark-pharma.de

Locations
Germany
Universitätsklinikum der Goethe-Universität Recruiting
Frankfurt, Germany
Universitätsmedizin Göttingen, Georg-August-Universität Recruiting
Göttingen, Germany
Universitätsklinikum Jena Recruiting
Jena, Germany
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany
Universitätsklinikum Gießen und Marburg GmbH Recruiting
Marburg, Germany
TU München, Klinikum rechts der Isar Recruiting
München, Germany
Klinikum der Universität München (LMU) Recruiting
München, Germany
Universitätsklinikum Münster Recruiting
Münster, Germany
Universitätsmedizin Rostock Recruiting
Rostock, Germany
Sponsors and Collaborators
Nordmark Arzneimittel GmbH & Co. KG
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
ProjectPharm s.r.o.
Investigators
Study Director: Kristin Forssmann, MD Nordmark Arzneimittel GmbH & Co. KG
Principal Investigator: Martin Canis, MD Department for Otolaryngology, University Göttingen Medical Center
  More Information

No publications provided

Responsible Party: Nordmark Arzneimittel GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01621256     History of Changes
Other Study ID Numbers: NM-V-101, 2012-000066-37
Study First Received: June 12, 2012
Last Updated: August 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 22, 2014