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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01621256
Other study ID # NM-V-101
Secondary ID 2012-000066-37
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2013
Est. completion date October 30, 2018

Study information

Verified date December 2018
Source Nordmark Arzneimittel GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date October 30, 2018
Est. primary completion date September 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Drug:
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

Locations

Country Name City State
Czechia Site CZ Hradec Králové
Czechia Site CZ Praha
Germany Site D Göttingen
Germany Site D Hamburg
Germany Site D Hannover
Germany Site D Landsberg am Lech
Germany Site D München

Sponsors (6)

Lead Sponsor Collaborator
Nordmark Arzneimittel GmbH & Co. KG ClinSupport GmbH, LCR Leading Clinical Research s.r.o., MWI Medizinisches Wirtschaftsinstitut GmbH, ProjectPharm s.r.o., X-act Cologne Clinical Research GmbH

Countries where clinical trial is conducted

Czechia,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient assessment of change in hearing impairment From baseline to Day 8, Day 30 and Day 90
Other Change in fibrinogen concentration From baseline to Day 2 and Day 8
Other Change in biomarkers From baseline to Day 8
Primary Change in PTA (pure tone audiogram) in the affected ear From baseline to Day 8
Secondary Change in speech recognition in the affected ear From baseline to Day 8
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