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Clinical Trials/NL-OMON56096
NL-OMON56096
Recruiting
Phase 2

Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss. - AC102-201

Audiocure Pharma GmbH0 sites20 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Audiocure Pharma GmbH
Enrollment
20
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
  • •approved informed consent form (ICF)
  • •2\. Female or male patients aged between 18 and 85 years (inclusive) at the day
  • •of Screening
  • •3\. Unilateral ISSNHL
  • •4\. Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
  • •5\. Patients with an absolute air conduction hearing threshold of at least 65 dB
  • •(average of the three most affected consecutive frequencies between 0\.25 and 8
  • •6\. Patients with a relative hearing loss of at least 30 dB compared to the
  • •current audiogram of the non\-affected ear (average of the three most affected

Exclusion Criteria

  • •1\. Insufficient handling of the language used in the speech audiometry tests
  • •2\. a) Bilateral hearing loss
  • •b) Sudden hearing loss in the only hearing ear (i.e. pre\-existing hearing loss
  • •in the contralateral ear of 40 dB or more measured by PTA in the range of 0\.5\-4
  • •3\. Acute hearing loss from noise trauma, barotrauma or head trauma in either
  • •ear at any time
  • •4\. Congenital hearing loss
  • •5\. Conductive hearing loss or combined hearing loss (determined by a 4PTA \> 10
  • •dB). Only if the limit for bone conduction is reached, tympanogram type can be
  • •used (other than A).

Outcomes

Primary Outcomes

Not specified

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