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Clinical trials for Acute Otitis Media

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
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    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 ).  
     
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    60 result(s) found for: Acute Otitis Media. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2018-000643-37 Sponsor Protocol Number: C-09-033 Start Date*: 2018-04-05
    Sponsor Name:Alcon Research Ltd
    Full Title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in 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, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 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: 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
    EudraCT Number: 2009-017319-13 Sponsor Protocol Number: C-09-033 Start Date*: Information not available in EudraCT
    Sponsor Name:Alcon Research Ltd.
    Full Title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes
    Medical condition: Acute otitis media with otorrhea in tympanostomy tubes
    Disease: Version SOC Term Classification Code Term Level
    12.1 10033079 Otitis media acute LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) BE (Completed) FI (Prematurely Ended) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000640-26 Sponsor Protocol Number: C-05-36 Start Date*: 2018-04-05
    Sponsor Name:Alcon Research Ltd
    Full Title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution Compared to Moxifloxacin Solution in the Treatment of Acute Otitis Media with Otorrhea through Tympanostomy Tubes (AOMT)
    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, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000642-19 Sponsor Protocol Number: C-05-38 Start Date*: 2018-04-05
    Sponsor Name:Alcon Research Ltd
    Full Title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Peri-Operative Tube Otorrhea
    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, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023238-22 Sponsor Protocol Number: CIFLOTIII/10IA02 Start Date*: 2011-07-29
    Sponsor Name:Laboratorios SALVAT, S.A.
    Full Title: A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic s...
    Medical condition: Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients. Otitis Media Aguda con Tubos de Timpanostomía(AOMT) en Pacientes Pediatricos
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) FI (Completed) DK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2010-023239-40 Sponsor Protocol Number: CIFLOTIII/10IA04 Start Date*: 2011-07-27
    Sponsor Name:Laboratorios SALVAT, S.A.
    Full Title: A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic s...
    Medical condition: Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) FI (Completed) DK (Completed) CZ (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: 2014-003595-23 Sponsor Protocol Number: CIP-DEX/001/14 Start Date*: 2014-12-17
    Sponsor Name:Watson Laboratories Inc.
    Full Title: A double-blinded, parallel-group, randomized, single dose study to assess the pharmacokinetic bioequivalence of ciprofloxacin (0.3%) and dexamethasone (0.1%) otic suspension (Indoco for Actavis) ve...
    Medical condition: Patients with current or previous history of acute otitis media (AOM) and recurrent acute otitis media (RAOM).
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
    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: 2006-006220-19 Sponsor Protocol Number: SUM-2006/01-INT Start Date*: 2008-11-27
    Sponsor Name:PLIVA Hrvatska d.o.o.
    Full Title: Safety and Efficacy of Sumamed® Therapy in the Treatment of Respiratory Tract Infections in Adults and Children: International, Multicenter, Non-Comparative Study
    Medical condition: acute pharyngitis/tonsilitis acute sinusitis acute otitis media acute exacerbation of chronic bronchitis community acquired pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001002 Acute pharyngitis LLT
    9.1 10001093 Acute tonsillitis LLT
    9.1 10001076 Acute sinusitis LLT
    9.1 10033079 Otitis media acute LLT
    9.1 10000743 Acute exacerbation of chronic bronchitis LLT
    9.1 10010120 Community acquired pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed) CZ (Ongoing)
    Trial results: (No results available)
    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: 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: 2004-004290-29 Sponsor Protocol Number: BY 221 OM2 Start Date*: 2004-11-29
    Sponsor Name:University of Oxford
    Full Title: Randomised controlled trial of effect of antibiotic dose on antibiotic resistance in young children with otitis media
    Medical condition: Acute otitis media
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-015103-58 Sponsor Protocol Number: V114-001 Start Date*: 2010-01-14
    Sponsor Name:MSD Finland Oy
    Full Title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar™ in Healthy Adults and Toddlers
    Medical condition: Prevention of pneumococcal invasive disease, pneumococcal pneumonia, and otitis media caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, 1, 5, 7F, 3...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10054047 Pneumococcal sepsis LLT
    12.1 10058886 Pneumococcal bacteremia LLT
    12.1 10027253 Meningitis pneumococcal LLT
    12.1 10035647 Pneumococcal pneumonia LLT
    12.1 10033079 Otitis media acute LLT
    Population Age: Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2017-000820-83 Sponsor Protocol Number: NNL-2017 Start Date*: 2017-07-03
    Sponsor Name:University of Oulu
    Full Title: Otitis Media and Nasopharyngeal Microbiome in Children. The change of nasopharyngeal microbiome and its role as a risk factor of otitis media. Streptococcus salivarius K12 and the change of nasop...
    Medical condition: We investigate role of microbiota as the risk factor of acute otitis media in children.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10033071 Otitis LLT
    20.1 100000004862 10069718 Bacterial colonization LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004164-38 Sponsor Protocol Number: A0661190 Start Date*: 2015-04-06
    Sponsor Name:Pfizer Inc
    Full Title: An Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release (IR) Or Extended-Release (ER) Formulation...
    Medical condition: Acute otitis media
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002927-27 Sponsor Protocol Number: OY20167 Start Date*: 2016-08-15
    Sponsor Name:University of Oulu, Department of Pediatrics, PEDEGO-Research unit
    Full Title: Effect of antimicrobial treament of acute otitis media on the intestinal micobiome in children: A randomized controlled trial
    Medical condition:
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
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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
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