EUCTR2008-000132-40-DEActive, not recruitingNot Applicable
Efficacy of AM 111 in Patients with Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Auris Medical AG
- Enrollment
- 204
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients with unilateral acute sensorineural hearing loss (ASNHL) with onset 48 hours or less ago
- •Mean hearing loss compared with the unaffected contralateral ear* of at least 30 dB in the 3 most affected contiguous frequencies
- •Age = 18 years and = 60 years
- •Negative pregnancy test for women of childbearing potential
- •Able to attend the on-study visits
- •Written informed consent before participation in the study
- •* For patients with asymmetric hearing or bilateral ASNHL resulting from acoustic trauma (most affected ear is treated), hearing loss is determined against a pre-existing audiogram (not older than 3 years), or, if no pre-existing audiogram is available, age- and sex-adjusted normative values according to ISO 7029:2000 (Statistical distribution of hearing thresholds as a function of age adjusting for the age-related hearing loss”).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Bilateral ASNHL, if not resulting from acoustic trauma
- •Suspected perilymph fistula or membrane rupture
- •Barotrauma
- •Average air bone gap higher than 20 dB in 3 contiguous frequencies
- •History of Meniere disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion or fluctuating hearing loss
- •Previous ASNHL incident within the past 6 weeks
- •Evidence of acute or chronic otitis media or otitis externa on examination
- •Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks
- •Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion
Investigators
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