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Clinical trials for children

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   44381   clinical trials with a EudraCT protocol, of which   7393   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.
    How to search [pdf]
    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.
    Study title: Retrospective survey for documentation of appllication and dosage of Abropernol N (tablets) in children < 12 years of age [Bef-014]
    Active substance: Abropernol - Tabletten
    Study summary document link (including results):
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    Document reference: 39761
    Study title: Assessment of efficacy and tolerability of Acarbose in children under 16 years
    Active substance: ACARBOSE
    Study summary document link (including results): Bayer Pharma_Acarbose_9981_study_synopsis.pdf
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    Document reference: 46160
    Study title: Clinical Study on the Efficacy and Tolerability of Acarbose (BAY g 5421) Compared with Placeboin Diabetic Children on Conventional Insulin Treatment, in Particular with Observation of the Glycemic Control Index ( PH-24820 )
    Active substance: ACARBOSE
    Study summary document link (including results): Bayer Pharma_Acarbose_0665_study_synopsis.pdf
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    Document reference: 46158
    Study title: Clinical Study to Investigate the Efficacy and Tolerability of Acarbose (BAY g 5421) Versus Placebo in Diabetic Children (PH 23433)
    Active substance: ACARBOSE
    Study summary document link (including results): Bayer Pharma_Acarbose_0634_study_synopsis.pdf
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    Document reference: 46155
    Study title: NON RANDOMISED FOLLW-UP STUDY WITH ACARBOSE-TREATMENT AND PRE- AND AFTER-TREATMENT WITH PLACEBO IN DIABETIC CHILDREN (TYPE I) STUDY 0428 (PH 14352)
    Active substance: ACARBOSE
    Study summary document link (including results): Bayer Pharma_Acarbose_0428_study_synopsis.pdf
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    Document reference: 46156
    Study title: The effect of acarbose (Bay G 5421) on the insulin consumption of children treated with insulin.
    Active substance: ACARBOSE
    Study summary document link (including results): Bayer Pharma_Acarbose_0221_study_synopsis.pdf
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    Document reference: 46157
    Study title: Clinical and echocardiographic (echo) long-term follow-up of children with severe hypertension (HT) - Loirat C. et al. - No date (Hopital Bretonneau, INSERM U 120, Paris) ; - Publication in Documentation clinique du dossier d'AMM du 30/10/1987 -
    Active substance: ACEBUTOLOL
    Study summary document link (including results):
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    Document reference: 46183
    Study title: Clinical pharmacology and therapeutic utilization of anti-hypertensive agents in children - Mirkin B.L., Sinaiko - 1977 In : (New M.I., Levine L.S. Juvenile hypertension, pp. 195-218. New-York, Raven Press.) - Publication in expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 -
    Active substance: ACEBUTOLOL
    Study summary document link (including results):
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    Document reference: 46184
    Study title: Propanolol as an antihypertensive agent in children - Griswold W.R., Moneal R., Mendoza S.A. et al. - 1978 (Arch. Dis. Child. 537. pp 594-596) - Publication in Expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 -
    Active substance: ACEBUTOLOL
    Study summary document link (including results):
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    Document reference: 46189
    Study title: Report of the task force on blood pressure control in children - Blumenthal S., Epps R.P., Heavenrich R., Laver R.M., Lieberman E. and al. - 1977 (Pediatrics, suppl., 59, 797) ; - Publication in expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 -
    Active substance: ACEBUTOLOL
    Study summary document link (including results):
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    Document reference: 46191
    Study title: Evaluation of ibuprofen versus Aspirin and Paracetamol on efficacy and comfort in children with fever - E. Autret, J. Reboul-Marty, B. Henry-Launois, C. Laborde, S. Courcier, JM Goehrs, G. Languillat, R. Launois - 1997 - Publication in the CES0079 - L. Baret-Cormel - 05 dec 2002 -
    Active substance: ACETYL SALICYLIC ACID
    Study summary document link (including results):
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    Document reference: 46181
    Study title: Evaluation of ibuprofen versus Aspirin and Paracetamol on efficacy and comfort in children with fever - E. Autret, J. Reboul-Marty, B. Henry-Launois, C. Laborde, S. Courcier, JM Goehrs, G. Languillat, R. Launois - 1997 - Publication -
    Active substance: ACETYL SALICYLIC ACID
    Study summary document link (including results):
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    Document reference: 46164
    Study title: A possible role for somatostatin receptor scintigraphy in the diagnosis and follow-up of children with medulloblastoma.Müller HL, Frühwald MC, Scheubeck M, Rendl J, Warmuth-Metz M, Sörensen N, Kühl J, Reubi JC.; . J Neurooncol. 1998 May;38(1):27-40.
    Active substance: (111In) INDIUM CHLORIDE/PENTETREOTIDE
    Study summary document link (including results):
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    Document reference: 21235
    Study title: [Bone metabolism in thalassemic children with multiple transfusions. Compartmental analysis of 99mTc-Sn-MDP kinetics] Italian. Mele M, De Mattia D, D'Addabbo A, Schettini F, Lauriero F, Rubini G. Radiol Med (Torino). 1989 Nov;78(5):455-60. Italian.
    Active substance: TECHNETIUM (99mTc) MEDRONIC ACID
    Study summary document link (including results):
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    Document reference: 43778
    Study title: TREATMENT OF CHICKENPOX IN CHILDREN WITH ZOVIRAX SUSPENSION IN A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
    Active substance: ACICLOVIR
    Study summary document link (including results): Study ZOVIRAX- 183 Aciclovir Oral.xls
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    Document reference: 46214
    Study title: Shibata et al. Therapeutic experience with GC-120 in children with renal tubular acidosis. Shoni Nalka 1988; 20(5): 785-789 2. Shibata et al. Therapeutic experience with GC-120 in children with renal tubular acidosis. Shoni Nalka 1988; 20(5): 785-789 2.
    Active substance: ACIDIFIERS
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    Document reference: 46217
    Study title: Suwa et al. The use of GC-120 in children in renal tubular acidosis. Shinyaku to Rhinsho 1986, 35(8): 2(1778)-5(1803).Suwa et al. The use of GC-120 in children in renal tubular acidosis. Shinyaku to Rhinsho 1986, 35(8): 2(1778)-5(1803).
    Active substance: ACIDIFIERS
    Study summary document link (including results):
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    Document reference: 46218
    Study title: Acitretin in Children. Retinoids: 10 Years On. Basel Karger, 1991:228-232 Acitretin in Children. Retinoids: 10 Years On. Basel Karger, 1991:228-232
    Active substance: ACITRETIN
    Study summary document link (including results):
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    Document reference: 46219
    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: Evaluation of anthroposophic supportive medicine on treatment -related toxicity in children receiving cancer therapy.
    Active substance: acqueous extract(1:20) from fresh herb of white-berry mistletoe (Viscum album L.): HELIXOR® A: produced from mistletoe growing on fir (Viscum album L. abietis), HELIXOR® M: produced from mistletoe growing on apple tree (Viscum album L. mali), HELIXOR® P: produced from mistletoe growing on pine (Viscum album L. pini)
    Study summary document link (including results):
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    Document reference: 39775
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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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