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Clinical trials for Acoustic trauma

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    9 result(s) found for: Acoustic trauma. Displaying page 1 of 1.
    EudraCT Number: 2020-005741-17 Sponsor Protocol Number: 76096 Start Date*: 2021-08-25
    Sponsor Name:Amsterdam University Medical Centers, location AMC
    Full Title: Hyperbaric OXygen therapy for ACute Acoustic Trauma
    Medical condition: Acute acoustic trauma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-005178-10 Sponsor Protocol Number: AM-101-CL-08-01 Start Date*: 2009-01-27
    Sponsor Name:Auris Medical AG
    Full Title: Efficacy of AM 101 in Patients with Acute Inner Ear Tinnitus: A Multi-Centre, Double-Blind, randomised, Placebo-Controlled, Multiple Dose, Group Comparison Phase II Study
    Medical condition: Acute inner ear tinnitus following acute acoustic trauma, sudden deafness, or acute otitis media.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000242-22 Sponsor Protocol Number: STR001-202 Start Date*: 2017-06-28
    Sponsor Name:STREKIN AG
    Full Title: A Phase III multicenter, double-blind, placebo-controlled, study evaluating the safety, and efficacy of STR001 treatment in adults with Sudden Sensorineural Hearing Loss
    Medical condition: Sudden Sensorineural Hearing Loss (SSHL) including - idiopathic unilateral Sensorineural Hearing Loss - acute uni- or bilateral acoustic trauma-induced Sensorineural Hearing Loss
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10040016 Sensorineural hearing loss LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-000132-40 Sponsor Protocol Number: AM-111-CL-08-01 Start Date*: 2008-11-18
    Sponsor Name:Auris Medical AG
    Full Title: Efficacy of AM 111 in Patients with Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
    Medical condition: Acute sensorineural hearing loss (ASNHL), which may be triggered by acoustic trauma, middle or inner ear surgery, i.e. known or evident insults to the inner ear. ASNHL may also result from a variet...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10013993 - Ear and labyrinth disorders 10040016 Sensorineural hearing loss LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-005587-26 Sponsor Protocol Number: AM-101-CL-12-01 Start Date*: 2014-05-27
    Sponsor Name:Auris Medical Inc.
    Full Title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2 (TACTT2)
    Medical condition: Acute peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    18.0 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-005384-24 Sponsor Protocol Number: AM-101-CL-10-02 Start Date*: 2012-02-06
    Sponsor Name:Auris Medical AG
    Full Title: TACTT1
    Medical condition: Acute inner ear tinnitus following acute acustic trauma, acute otitis media, middle ear surgery, or inner ear barotrauma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-002692-41 Sponsor Protocol Number: AM-101-AAT-PHA1 Start Date*: 2006-09-15
    Sponsor Name:Laboratoires Auris SAS
    Full Title: Safety of AM-101 in Patients with Acute Inner Ear Tinnitus from Noise Trauma: a Dose-Finding Phase I/II Study
    Medical condition: Inner ear tinnitus
    Disease: Version SOC Term Classification Code Term Level
    8.1 10043882 Tinnitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004099-20 Sponsor Protocol Number: AM-101-CL-12-02 Start Date*: 2013-10-30
    Sponsor Name:Auris Medical AG
    Full Title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3)
    Medical condition: acute peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    18.1 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) DE (Completed) AT (Completed) GB (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-000812-47 Sponsor Protocol Number: SENS401-201 Start Date*: 2018-09-24
    Sponsor Name:SENSORION SA
    Full Title: A two- part, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss
    Medical condition: Sudden sensorineural hearing loss (SSNHL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10040016 Sensorineural hearing loss LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BG (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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