Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005539

Trial Description

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Title

Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005539
  •   2014/08/22
  •   2012/06/12
  •   no
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Secondary IDs

  •   2012-000066-37 
  •   NCT01621256  (ClinicalTrials.gov)
  •   NM-V-101  (Nordmark Arzneimittel GmbH & Co. KG)
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Health Condition or Problem studied

  •   Hearing Loss
  •   Deafness
  •   Hearing Loss, Sensorineural
  •   Hearing Disorders
  •   Ear Diseases
  •   H91.9 -  Hearing loss, unspecified
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Interventions/Observational Groups

  •   Drug: Ancrod
  •   Drug: Saline solution
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   I-II
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Primary Outcome

- Change in PTA (pure tone audiogram) in the affected ear; time frame: From baseline to Day 8

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Secondary Outcome

- Change in speech recognition in the affected ear; time frame: From baseline to Day 8

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Countries of Recruitment

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  •   Germany
  •   Czech Republic
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Locations of Recruitment

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Recruitment

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  •   2013/05/31
  •   115
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional 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

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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

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Addresses

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    • Nordmark Arzneimittel GmbH & Co. KG
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    • ClinSupport GmbH
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    • MWI Medizinisches Wirtschaftsinstitut GmbH
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    • ProjectPharm s.r.o.
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    • LCR Leading Clinical Research s.r.o.
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    • X-act Cologne Clinical Research GmbH
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    • Department for Otorhinolaryngology, LM University Munich
    • Martin Canis, MD PhD 
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    • Department for Otorhinolaryngology, LM University Munich
    • Martin Canis, MD PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2018/10/30
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2019/02/18
* This entry means the parameter is not applicable or has not been set.