Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
NCT ID: NCT01621256
Last Updated: 2018-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
31 participants
INTERVENTIONAL
2013-05-31
2018-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ancrod
Ancrod
Ancrod
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Saline solution
Saline solution
Saline solution
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Interventions
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Ancrod
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Saline solution
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symmetric hearing prior to onset of SSHL
* Enrollment has to be accomplished within 7 days after SSHL onset
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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ClinSupport GmbH
INDUSTRY
MWI Medizinisches Wirtschaftsinstitut GmbH
UNKNOWN
ProjectPharm s.r.o.
UNKNOWN
LCR Leading Clinical Research s.r.o.
UNKNOWN
X-act Cologne Clinical Research GmbH
INDUSTRY
Nordmark Arzneimittel GmbH & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Canis, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department for Otorhinolaryngology, LM University Munich
Locations
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Site CZ
Hradec Králové, , Czechia
Site CZ
Prague, , Czechia
Site D
Göttingen, , Germany
Site D
Hamburg, , Germany
Site D
Hanover, , Germany
Site D
Landsberg am Lech, , Germany
Site D
München, , Germany
Countries
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Other Identifiers
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2012-000066-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NM-V-101
Identifier Type: -
Identifier Source: org_study_id