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Clinical trials for Primary Dentition

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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    8 result(s) found for: Primary Dentition. Displaying page 1 of 1.
    EudraCT Number: 2006-002192-40 Sponsor Protocol Number: periodld001 Start Date*: 2006-07-13
    Sponsor Name:Zsolt Lohinai DMD PhD
    Full Title: New treatment of periodontitis by inhibition of lysine decarboxilase enzyme
    Medical condition: healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004565-14 Sponsor Protocol Number: ECP-002e Start Date*: 2014-02-13
    Sponsor Name:Edimer Pharmaceuticals, Inc.
    Full Title: Extension Study of XLHED-Affected Male Subjects treated with EDI200 in Protocol ECP-002
    Medical condition: X-linked hypohidrotic ectodermal dysplasia (XLHED) is caused by inherited defects in the ectodysplasin (EDA) gene that disrupt synthesis and/or function of the primary translational product EDA-A1....
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10072592 Hypohidrotic ectodermal dysplasia LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male
    Trial protocol: DE (Completed) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-008594-58 Sponsor Protocol Number: GASAS-0809X Start Date*: 2009-07-24
    Sponsor Name:GABA International AG
    Full Title: In situ mineral change and fluoride retention of sound and demineralized enamel in high cariogenic milieus following the single application of a 1.25%- fluoride or a placebo gel.
    Medical condition: Remineralization, fluoride uptake, and lesion depth of sound and demineralized, plaque-covered enamel after the application of elmex gel will be tested in situ in comparison to a placebo gel.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-010725-39 Sponsor Protocol Number: 56493 Start Date*: 2009-07-23
    Sponsor Name:The University of Manchester [...]
    1. The University of Manchester
    2. Belfast Health and Social Care Trust
    Full Title: A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services
    Medical condition: Dental Caries
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10012318 Dental caries PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-002532-23 Sponsor Protocol Number: ER004-CLIN01/F60082AI201 Start Date*: 2021-10-25
    Sponsor Name:EspeRare Foundation [...]
    1. EspeRare Foundation
    2. Pierre Fabre Médicament
    Full Title: A prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intra-amniotic ER004 as a prenatal treatment for male subjects with X-link...
    Medical condition: X-linked hypohidrotic ectodermal dysplasia (XLHED)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10072592 Hypohidrotic ectodermal dysplasia LLT
    Population Age: In utero, Under 18 Gender: Male
    Trial protocol: DE (Ongoing) ES (Ongoing) FR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-003561-17 Sponsor Protocol Number: ECP-002 Start Date*: 2013-08-09
    Sponsor Name:Edimer Pharmaceuticals, Inc.
    Full Title: A Phase 2 open-label, dose-escalation study to evaluate the safety, pharmacokinetics, immunogeniticy and pharmacodynamics/efficacy of EDI200, an EDA-A1 replacement protein, administered to male inf...
    Medical condition: X-linked hypohidrotic ectodermal dysplasia (XLHED) is caused by inherited defects in the ectodysplasin (EDA) gene that disrupt synthesis and/or function of the primary translational product EDA-A1....
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10072592 Hypohidrotic ectodermal dysplasia LLT
    Population Age: Newborns, Under 18 Gender: Male
    Trial protocol: DE (Completed) GB (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002528-42 Sponsor Protocol Number: 0431-083 Start Date*: 2011-12-30
    Sponsor Name:Merck Sharp & Dohme Corp. A subsidiary of Merck & Co. Inc
    Full Title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Me...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) LT (Completed) DE (Completed) ES (Prematurely Ended) IT (Completed) BG (Completed) AT (Completed) DK (Completed) SE (Completed) HU (Completed) PL (Completed) SK (Completed) Outside EU/EEA GR (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000600-29 Sponsor Protocol Number: UX023-CL301 Start Date*: 2016-09-15
    Sponsor Name:Ultragenyx Pharmaceuticals Inc
    Full Title: A Randomized, Open-Label, Phase 3 Study to Assess the Efficacy and Safety of KRN23 Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients with X-linked Hypophosphatemia (XLH)
    Medical condition: X-linked hypophosphatemia (XLH) is a disorder of renal phosphate wasting, defective bone mineralisation, and impaired growth plate or endochondral ossification caused by inactivating mutations in t...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10016206 Familial hypophosphataemic rickets LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) IE (Completed) DE (Completed) ES (Prematurely Ended) SE (Completed) GB (Completed) IT (Prematurely Ended)
    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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