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Clinical trials for Middle Ear

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    38 result(s) found for: Middle Ear. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-004016-11 Sponsor Protocol Number: 2305 Start Date*: 2016-06-30
    Sponsor Name:University of Bristol
    Full Title: What is the clinical and cost effectiveness of benzocaine/phenazone ear drops for reducing antibiotic consumption and ear pain in children aged between 6 months and 10 years presenting to primary c...
    Medical condition: Acute otitis media
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10014020 Ear pain PT
    20.1 10013993 - Ear and labyrinth disorders 10065838 Middle ear inflammation PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-000341-13 Sponsor Protocol Number: OTV.PRE.01 Start Date*: 2012-08-28
    Sponsor Name:Weber & Weber GmbH & Co. KG
    Full Title: Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Grou...
    Medical condition: recurrent acute otitis media
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10033078 Otitis media PT
    16.1 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005123-32 Sponsor Protocol Number: SPON1030-11 Start Date*: 2013-04-17
    Sponsor Name:Cardiff University
    Full Title: Oral steroids for the resolution of otitis media with effusion in children study (OSTRICH)
    Medical condition: Otitis media with effusion.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10040113 Serous otitis media (glue ear) LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001076-14 Sponsor Protocol Number: K12-2020 Start Date*: 2020-04-20
    Sponsor Name:Oulu University Hospital, Oulu, Finland [...]
    1. Oulu University Hospital, Oulu, Finland
    2. University of Oulu
    Full Title: Efficacy of Streptococcus salivarius K12 oral probiotic products in preventing acute otitis media: A randomized placebo-controlled trial.
    Medical condition: Acute otitis media
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10033084 Otitis media NOS LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003019-24 Sponsor Protocol Number: 80-87200-98-1017 Start Date*: 2021-08-18
    Sponsor Name:University Medical Center Utrecht
    Full Title: Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: a pragmatic randomised controlled trial
    Medical condition: Acute otitis media
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    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: 2017-000332-34 Sponsor Protocol Number: NL-07051985 Start Date*: 2017-08-23
    Sponsor Name:Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
    Full Title: Topical or oral antibiotics for children with acute otitis media presenting with ear discharge?
    Medical condition: Acute otitis media with ear discharge
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10033080 Otitis media acute NOS LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (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: 2010-023991-15 Sponsor Protocol Number: KB042 Start Date*: 2011-03-10
    Sponsor Name:KEDRION
    Full Title: Efficay and Safety Evaluation of Kedrion Fibrin Sealant, in middle ear microsurgery. Monocenter, controlled, single blind, randomised, two parallel arms, phase II/III study
    Medical condition: Chronic otitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10033081 Otitis media chronic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003614-87 Sponsor Protocol Number: ET31068 Start Date*: 2015-03-27
    Sponsor Name:Oslo University Hospital
    Full Title: Novel Imaging of the Eustachian Tube, a CT study using dilute iodixanol in an adult population
    Medical condition: Otitis media With effusion
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2013-002077-21 Sponsor Protocol Number: AM-111-CL-13-01 Start Date*: 2015-10-15
    Sponsor Name:Auris Medical AG
    Full Title: Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
    Medical condition: Idiopathic sudden sensorineural hearing loss
    Disease: Version SOC Term Classification Code Term Level
    19.1 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) HU (Completed) ES (Prematurely Ended) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-006086-17 Sponsor Protocol Number: 55005646 Start Date*: 2012-07-10
    Sponsor Name:Maria Fernanda Pedrero Escalas
    Full Title: "Effectiveness of homeopathic treatment (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum and Arsenicum iodatum 9CH 9CH) as adjuvant secretory otitis in children"
    Medical condition: Pediatric patients aged 2 months to 12 years presenting secretory otitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10033072 Otitis externa PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    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: 2013-005588-24 Sponsor Protocol Number: AM-101-CL-12-03 Start Date*: 2014-05-27
    Sponsor Name:Auris Medical Inc.
    Full Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) – an open-label extension to the TACTT2 study
    Medical condition: Treatment of peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    19.0 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: 2010-019775-29 Sponsor Protocol Number: V114-003 Start Date*: 2010-09-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: "Estudio multicéntrico y doble ciego de la seguridad, la tolerabilidad y la inmunogenicidad de una vacuna antineumocócica conjugada (V114) en comparación con Prevenar 13™ en lactantes sanos";"A Mul...
    Medical condition: Prevención de la enfermedad invasiva neumocócica, la neumonía neumocócica y la otitis media causada por S. pneumoniae, debido a los serotipos capsulares incluidos en la vacuna (4, 6B,9V,14,18C,19F,...
    Disease: Version SOC Term Classification Code Term Level
    13 10054047 Sepsis neumocócica LLT
    13 10058886 Bacteriemia por neumococo LLT
    13 10027253 Meningitis neumocócica LLT
    13 10035647 Neumonía neumocócica LLT
    13 10033078 Otitis media LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) FI (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-001407-13 Sponsor Protocol Number: NL35847.068.11 Start Date*: 2011-05-11
    Sponsor Name:Maastricht Universitary Medical Centre
    Full Title: NasuMel® Gel - a Medical Grade Honey Product for the Treatment of Chronically Infected Radical Mastoid Cavities
    Medical condition: Chronically infected radical mastoidectomy cavity
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001527-39 Sponsor Protocol Number: AM-101-CL-12-04 Start Date*: 2013-11-21
    Sponsor Name:Auris Medical AG
    Full Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) – an open-label extension to the TACTT3 study
    Medical condition: Treatment of peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    19.0 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: 2014-004637-47 Sponsor Protocol Number: EFC6132,HMR3647B/3002 Start Date*: 2015-03-17
    Sponsor Name:Sanofi-aventis
    Full Title: Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 5 Days Azithromycin 10 mg/kg od Followed by 5 ...
    Medical condition: Otitis Media, Suppurative Otitis Media, Purulent
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10033092 Otitis media suppurative LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004917-10 Sponsor Protocol Number: P05155 Start Date*: 2015-03-03
    Sponsor Name:Schering-Plough S.A. de C.V.
    Full Title: A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Multicenter Clinical Trial To Evaluate Efficacy And Safety Of Mometasone Furoate Nasal Spray In Children With Adenoid Hypertrophy. SNO...
    Medical condition: Adenoid Hypertrophy.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002689-30 Sponsor Protocol Number: C-13-026 Start Date*: 2017-11-20
    Sponsor Name:Alcon Research Ltd
    Full Title: Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
    Medical condition: Acute otitis media
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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