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

NCT01621256 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-12-21

No results posted yet for this study

Summary

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

Conditions

  • Hearing Loss
  • Deafness
  • Hearing Loss, Sensorineural
  • Hearing Disorders
  • Ear Diseases

Interventions

DRUG

Ancrod

Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

DRUG

Saline solution

Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

Sponsors & Collaborators

  • ClinSupport GmbH

    collaborator INDUSTRY

  • MWI Medizinisches Wirtschaftsinstitut GmbH

    collaborator UNKNOWN

  • ProjectPharm s.r.o.

    collaborator UNKNOWN

  • LCR Leading Clinical Research s.r.o.

    collaborator UNKNOWN

  • X-act Cologne Clinical Research GmbH

    collaborator INDUSTRY

  • Nordmark Arzneimittel GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Martin Canis, MD PhD · Department for Otorhinolaryngology, LM University Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-09-18
Completion
2018-10-30

Countries

  • Czechia
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621256 on ClinicalTrials.gov