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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
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: A double-blind, multicenter, multi-dose, parallel group, placebo-controlled study on the efficacy and safety of a homeopathic combination remedy vs.placebo over 14 days of treatment in children with acute otitis media.
    Active substance: Aconitum napellus Dil. D6 0,075 ml; Capsicum annuum Dil. D4 0,075 ml; Chamomilla recutita Ø 0,225 ml; Echinacea purpurea Ø 0,75 ml; Hydrargyrum bicyanatum Dil. D6 0,075 ml; Hydrastis canadensis Dil. D4 0,075 ml; Iodum Dil. D4 0,075 ml; Natrium tetraboracicum Dil. D4 0,075 ml; Sambucus nigra Ø 0,225 ml; Sanguinaria canadensis Ø 0,075 ml.
    Study summary document link (including results):
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    Document reference: 39772
    Study title: 301: De Diego JI, Prim MP, Alfonso C, Sastre N, Rabanal I, Gavilan J. Comparison of amoxicillin and azithromycin in the prevention of recurrent acute otitis media. Int J Pediatr Otorhinolaryngol. 2001 Apr 6;58(1):47-51.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46614
    Study title: 350: Damoiseaux RA, van Balen FA, Hoes AW, Verheij TJ, de Melker RA. Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years. BMJ. 2000 Feb 5;320(7231):350-4.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46616
    Study title: 426: Scholz H, Noack R. Multicenter, randomized, double-blind comparison of erythromycin estolate versus amoxicillin for the treatment of acute otitis media in children. AOM Study Group. Eur J Clin Microbiol Infect Dis. 1998 Jul;17(7):470-8.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46619
    Study title: A multi-investigator randomized trial comparing the efficacy of BMY28100 versus amoxicillin/clavulanate potassium in the treatment of acute otitis media in children.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46587
    Study title: A randomized, investigator blinded, multicenter, comparative study of Gatifloxacin versus amoxicillin/clavulanate in the treatment of recurrent otitis media and acute otitis media treatment failures in children.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46591
    Study title: A randomized, investigator blinded, multicenter, comparative study of Gatifloxacin versus high dose amoxicillin/clavulanate in the treatment of recurrent otitis media and acute otitis media treatment failures in children.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46590
    Study title: Double blind, randomised, multi centre study comparing the efficacy and tolerance of amoxicillin 30mg/kg b.i.d. versus amoxicillin 15mg/kg t.i.d. in teh treatment of acute otitis media in children.
    Active substance: AMOXICILLIN
    Study summary document link (including results): AMX 1-97 CSR amended_020529.pdf
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    Document reference: 47091
    Study title: Garbutt J, St Geme JW 3rd, May A, Storch GA, Shackelford PG. Developing community-specific recommendations for first-line treatment of acute otitis media: is high-dose amoxicillin necessary? Pediatrics. 2004 Aug;114(2):342-7.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46604
    Study title: Garrison GD, Sorum PC, Hioe W, Miller MM. High-dose versus standard-dose amoxicillin for acute otitis media. Ann Pharmacother. 2004 Jan;38(1):15-9.
    Active substance: AMOXICILLIN
    Study summary document link (including results):
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    Document reference: 46607
    Study title: Le Saux N, Gaboury I, Baird M, Klassen TP, MacCormick J, Blanchard C, Pitters C, Sampson M, Moher D. A randomized, double-blind, placebo-controlled noninferiority trial of amoxicillin for clinically diagnosed acute otitis media in children 6 months to 5 years of age. CMAJ. 2005 Feb 1;172(3):335-41.
    Active substance: AMOXICILLIN
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    Document reference: 46601
    Study title: A Comparison of the Safety and Efficacy of q 12 hours Augmentin-90/6.4 mg/kg/day and q 12 hrs Augmentin-45/6.4 mg/kg/day in the Treatment of Acute Otitis Media in Children: A Randomised Double-blind, Multicenter, Comparitive Study.
    Active substance: AMOXICILLIN AND CLAVUNALIC ACID
    Study summary document link (including results):
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    Document reference: 46632
    Study title: A Randomized , Investigator-Blind, Multicenter Study to Asses the efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 days Versus Oral Zithromax Once daily for 5 days in the treatment of Acute Otitis Media in Infants and Children
    Active substance: AMOXICILLIN AND CLAVUNALIC ACID
    Study summary document link (including results):
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    Document reference: 46631
    Study title: A single blind, randomized, multicenter study to assess the safety and efficacy of 5 days of Augmentin q12h (45/6.4mg/kg/day) compared with Zithromax q24h (10mg/kg on day 1 & 5mg/kg on days 2-5) in the treatment of acute otitis media in infants and children
    Active substance: AMOXICILLIN AND CLAVUNALIC ACID
    Study summary document link (including results): Study 25000-496 Augmentin (as Na).xls
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    Document reference: 46624
    Study title: An Open-Label Study to Demonstrate Bacteriological Efficacy of augmentin ES in the Treatment of Acute Otitis Media due to S.pneumonae
    Active substance: AMOXICILLIN AND CLAVUNALIC ACID
    Study summary document link (including results):
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    Document reference: 46630
    Study title: Comparison of Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of Augmentin 45/3.2 mg/kg to Pediatric Patients with Acute Otitis Media
    Active substance: AMOXICILLIN AND CLAVUNALIC ACID
    Study summary document link (including results): Augmentin-25000-446-ICH3.pdf
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    Document reference: 46621
    Study title: Concentrations of Amoxicillin and Clavulanate in plasma and middle ear fluid after administration of Augmentin 35/5 mg/Kg every 12 hours to children with acute otitis media
    Active substance: AMOXICILLIN AND CLAVUNALIC ACID
    Study summary document link (including results):
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    Document reference: 46623
    Study title: Efficacy & Safety of Augmentin 40/10 mg/kg/day tid for 10 days in the Treatment of Acute Otitis Media (AOM) Due to Drug-Resistant Streptococcus Pneumoniae (DRSP) in Children
    Active substance: AMOXICILLIN AND CLAVUNALIC ACID
    Study summary document link (including results): Study 25000-410 -BRL-025000-RSD-100LM8-2 Augmentin (as trihydrate).xls
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    Document reference: 46622
    Study title: Measuring the comparative efficacy of antibacterial agents for acute otitis media: the "Pollyanna phenomenon";J Pediatr. 1992 Jan;120(1):72-7Measuring the comparative efficacy of antibacterial agents for acute otitis media: the "Pollyanna phenomenon";J Pediatr. 1992 Jan;120(1):72-7
    Active substance: BENZATHINE BENZYLPENICILLIN
    Study summary document link (including results):
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    Document reference: 22274
    Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in childrenClinical efficacy and tolerance of bacampicillin and amoxycillin suspensions in children with acute otitis media; J Int Med Res. 1989 Jan-Feb;17(1):41-7.
    Active substance: BENZATHINE BENZYLPENICILLIN
    Study summary document link (including results):
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    Document reference: 22276
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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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