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Clinical trials for 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
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   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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    81 result(s) found for: Otitis media. Displaying page 2 of 5.
    « Previous 1  2  3  4  5  Next»
    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: 2012-001665-33 Sponsor Protocol Number: Koti Start Date*: 2012-06-14
    Sponsor Name:Päijät-Häme Central Hospital
    Full Title:
    Medical condition: Otitis media acuta
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    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 (Completed)
    Trial results: View results
    EudraCT Number: 2006-002482-39 Sponsor Protocol Number: PM L 0199 Start Date*: 2006-10-20
    Sponsor Name:SANOFI-AVENTIS OTC
    Full Title: Evaluation of the effects of Enterogermina, 2 billion Bacillus clausii spores, on the intestinal flora of children antibiotic treated for bacterial upper respiratory tract infections open, pilot s...
    Medical condition: Subjects with persistency of symptoms and requiring antibiotics for bacterial upper respiratory tract infections, i.e. complicated acute otitis media diagnosed by otoscopic examination or beta-ha...
    Disease: Version SOC Term Classification Code Term Level
    6.1 10017947 SOC
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002742-37 Sponsor Protocol Number: 66735.041.18 Start Date*: 2018-09-12
    Sponsor Name:University Medical Center Utrecht
    Full Title: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection – a randomized controlled trial
    Medical condition: respiratory syncytial virus infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-009037-14 Sponsor Protocol Number: AUR-OM-201 Start Date*: 2009-02-25
    Sponsor Name:Auris ehf.
    Full Title: A randomised, blinded, phase IIa, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of repeat doses of thymol solution 4% administered to the outer ear canal ...
    Medical condition: Acute Otitis Media
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IS (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: View results
    EudraCT Number: 2015-001763-39 Sponsor Protocol Number: MU1441 Start Date*: 2015-09-09
    Sponsor Name:Ardeypharm GmbH
    Full Title: E. coli Nissle 1917 - Suspension for infection prophylaxis
    Medical condition: Following viral and bacterial infections: - Acute upper respiratory tract infections (i.e. rhinopharyngitis, laryngitis, angina tonsillitis, tracheitis) - Acute lower respiratory tract infectio...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003439-53 Sponsor Protocol Number: TMC353121-TiDP19-C202 Start Date*: 2006-12-08
    Sponsor Name:Tibotec Pharmaceuticals Ltd
    Full Title: A double blind, randomized, placebo-controlled study to evaluate the antiviral activity, safety and plasma pharmacokinetics of multiple intravenous doses of TMC353121 in hematopoietic stem cell tra...
    Medical condition: Respiratory Synctycial Virus (RSV)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-000166-21 Sponsor Protocol Number: 1 Start Date*: 2007-06-22
    Sponsor Name:Whipps Cross University Hospital
    Full Title: A comparison of the efficacy of 10% lidocaine solution and EMLA cream as local anaesthetic for the insertion of tympanic membrane ventilation tubes.
    Medical condition: Grommet/ventilation tube insertion in adults with otitis media with effusion (glue ear).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024759 Local anaesthetic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001529-41 Sponsor Protocol Number: 0887X1-4596 Start Date*: 2017-06-02
    Sponsor Name:Pfizer Inc.
    Full Title: Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
    Medical condition: Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001958-10 Sponsor Protocol Number: IMUNOR-201301 Start Date*: 2013-09-04
    Sponsor Name:ImunomedicA, a.s.
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Confirmatory Study Assessing Efficacy and Safety of the IMUNOR Therapy Versus Placebo in Children with Recurrent ...
    Medical condition: Recurrent Respiratory Tract Infections
    Disease: Version SOC Term Classification Code Term Level
    16.0 10042613 - Surgical and medical procedures 10067473 Immunomodulatory therapy PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011159-29 Sponsor Protocol Number: PDA Start Date*: 2009-06-23
    Sponsor Name:Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau
    Full Title: Ensayo clínico sobre la evaluación de las estrategias de tratamiento diferido con antibióticos en las infecciones respiratorias agudas no complicadas en atención primaria (Estudio PDA)
    Medical condition: Non-complicated acute respiratory infections
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (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: 2004-000738-34 Sponsor Protocol Number: HMR3647B/3001 Start Date*: 2005-09-20
    Sponsor Name:Aventis Pharmaceuticals, Inc.
    Full Title: Multinational, randomized, double-blind, double-dummy, comparative study to evaluate the efficacy and safety of telithromycin 25 mg/kg given once daily for 5 or 10 days depending on age and previou...
    Medical condition: Acute otitis media in children.
    Disease: Version SOC Term Classification Code Term Level
    7 10021881 2
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004077-32 Sponsor Protocol Number: BCRU/11/Ibu-AOM/001 Start Date*: 2015-12-29
    Sponsor Name:Berlin-Chemie AG
    Full Title: A randomized open-label, multinational, multicentre, phase III clinical study to evaluate the efficacy and safety of Ibuprofen oral suspension 20 mg/ml and Ibuprofen oral suspension 40 mg/ml (Berli...
    Medical condition: Acute otitis media (AOM) is an acute inflammatory disease involving the mucosa of the middle ear. AOM is one of the most frequent complications of upper respiratory tract infections in children. T...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004904-74 Sponsor Protocol Number: INFQ3003 Start Date*: 2017-09-07
    Sponsor Name:Abbott Biologicals B.V.
    Full Title: A Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s ...
    Medical condition: Prophylaxis of Influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022005 Influenza viral infections HLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) DK (Completed) EE (Ongoing) CZ (Completed) LT (Completed) BG (Completed) IT (Completed) SI (Completed) ES (Completed) FR (Not Authorised) HR (Completed) HU (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-001496-48 Sponsor Protocol Number: OTI179 Start Date*: Information not available in EudraCT
    Sponsor Name:BIOCODEX
    Full Title: Evaluation de l'efficacité d’une solution de chlorhydrate de lidocaïne 1% et de phénazone 4% en gouttes auriculaires (Otipax®) dans l’otite moyenne aiguë congestive de l’enfant Etude clinique ouv...
    Medical condition: Congestive acute otitis media of children
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    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
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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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