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Clinical trials for Product

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 ).  
     
    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.
    Advanced Search: Search tools
     
    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: Clinical expert's report of the product theralene pectoral bebe syrup 2585 TH (paediatrics) - Chaptal - 31/03/66
    Active substance: ALIMEMAZINE
    Study summary document link (including results):
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    Document reference: 46437
    Study title: COG study : Outcome of children with Bprecursor ALL registered on Pediatric Oncology Group 8602 who switched to Erwinia due to an allergy to the E.coli product
    Active substance: ASPARAGINASE
    Study summary document link (including results):
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    Document reference: 21957
    Study title: Outcome of children with Bprecursor ALL registered on Pediatric Oncology Group 8602 who switched to Erwinia due to an allergy to the E.coli product (COG study)
    Active substance: ASPARAGINASE
    Study summary document link (including results):
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    Document reference: 21918
    Study title: Retrospective multicenter study on the incidence of hemostatic complications and the frequency of prophylactic replacement of plasma-derived products among children with ALL who underwent ASP therapy
    Active substance: ASPARAGINASE
    Study summary document link (including results):
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    Document reference: 21900
    Study title: REPRODUCTIVE STUDY, SEGMENT I, RODENT EXPERIMENT, RAT. (EFFECT OF DRUG ON FERTILITY AND REPRODUCTIVE PERFORMANCE); ORIGIN=PCS US / SU; CONTRACTOR=1;
    Active substance: BACLOFEN
    Study summary document link (including results):
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    Document reference: 22073
    Study title: Reproductive study, Segment III, Rodent experiment, Rat. (Perinatal and Postnatal effects of drug); Origin=PCS US / SU; Contractor=1;
    Active substance: BACLOFEN
    Study summary document link (including results):
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    Document reference: 22082
    Study title: Efficacy and safety of Symbioflor 1 in children and adolescents with chronic recurrent sinusitis (non-interventional trial)
    Active substance: Bacterial culture with MGE-score of at least 6 consisting of 1.5–4.5 x 107 cells capable and not capable of reproduction and cell debris of Enterococcus faecalis (DSM 16440)
    Study summary document link (including results):
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    Document reference: 21213
    Study title: Efficacy and safety of Symbioflor 2 in children with irritable bowel syndrome (non-interventional trial); Martens -Probiotic treatment of irritable bowel syndrome in children -Symbioflor2en 2010
    Active substance: Bacterial culture with MGE-score of at least 8 consisting of 1.5–4.5 x 107 cells capable and not capable of reproduction and cell debris of Escherichia coli (DSM 17252)
    Study summary document link (including results):
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    Document reference: 41389
    Study title: Comparison of nebulized beclomethasone dipropionate and nebulized budesonide in asthma of infants and young children. Multicentre, randomized, controlled, open-label study versus reference product in 2 parallel groups over 14 weeks including a 2-week run-in , in severe or persistent asthma in infants and young children of the equivalent safety and efficacy of the addition, to the usual maintenance treatment, of 800 µg of nebulized beclomethasone dipropionate or 750 µg of nebulized Pulmicort® twice a day.
    Active substance: BECLAMETHASONE
    Study summary document link (including results):
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    Document reference: 22229
    Study title: ZD7054 and ZD1033: 90 Day Oral Toxicity Study in the Juvenile Male Rat with Assessment and Recovery of Reproductive Function
    Active substance: BICALUTAMIDE
    Study summary document link (including results): 0514GR CSR Synopsis[1].pdf
    View full study record
    Document reference: 41873
    Study title: A marketing comparative study of Benoxyl 5 lotion and four other 5% BPO competitor products; Vixiderm, Benzihex and Vixiderm gel in patients with facial acne.
    Active substance: BENZOYL PEROXIDE
    Study summary document link (including results): Article 45_Ref_C0266_Final for Submission_07Nov2011.xlsx
    View full study record
    Document reference: 22319
    Study title: Study of the efficacy and tolerability of BAY H 4502 cream 1% in the treatment of patients suffering from tinea corporis and/or tinea inguinalis in comparison with a commercial product containing miconazole cream 2%
    Active substance: BIFONAZOLE
    Study summary document link (including results):
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    Document reference: 22413
    Study title: Clinical expert report on the product LA 96 A in pediatrics.
    Active substance: BISACODYL
    Study summary document link (including results): Bisacodyl_U65-0193_synopsis.pdf
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    Document reference: 22719
    Study title: Clinical trial of the product LA 96 A (Dulcolax) suppositories
    Active substance: BISACODYL
    Study summary document link (including results): Bisacodyl_U70-0375_synopsis.pdf
    View full study record
    Document reference: 22720
    Study title: Brewer M et al, Outcome and reproductive function after chemotherapy for ovarian dysgerminoma, J Clin Oncol. 1999 Sep;17(9):2670-75Brewer M et al, Outcome and reproductive function after chemotherapy for ovarian dysgerminoma, J Clin Oncol. 1999 Sep;17(9):2670-75
    Active substance: BLEOMYCIN
    Study summary document link (including results):
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    Document reference: 22753
    Study title: J Int Med Res. 1995 May-Jun;23(3):175-83. Efficacy and tolerability of levodropropizine and dropropizine in children with non-productive cough. Banderali G, Riva E, Fiocchi A, Cordaro CI, Giovannini M. J Int Med Res. 1995 May-Jun;23(3):175-83. Efficacy and tolerability of levodropropizine and dropropizine in children with non-productive cough. Banderali G, Riva E, Fiocchi A, Cordaro CI, Giovannini M.
    Active substance: DROPROPIZINE
    Study summary document link (including results): Banderali G.xls
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    Document reference: 24412
    Study title: A Twelve-Week, Randomized, Double-Blind, Double-Dummy Trial of Symbicort® (40/4.5 mcg) versus its Mono-Products (budesonide and formoterol) in Asthmatic Children Aged Six to Fifteen Years – SEEDLING 40/4.5
    Active substance: BUDESONIDE
    Study summary document link (including results):
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    Document reference: 22953
    Study title: A Twelve-Week, Randomized, Double-Blind, Double-Dummy Trial of Symbicort® (40/4.5 mcg) versus its Mono-Products (budesonide and formoterol) in Asthmatic Children Aged Six to Fifteen Years – SEEDLING 40/4.5
    Active substance: BUDESONIDE AND FORMOTEROL
    Study summary document link (including results): SD-039-0725 CSR Synopsis.pdf
    View full study record
    Document reference: 23021
    Study title: Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000).Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000).
    Active substance: CAMPHOR AND DIPHENHYDRAMINE AND ZINC
    Study summary document link (including results):
    View full study record
    Document reference: 23188
    Study title: A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of SYMBICORT® pMDI (80/4.5 mg) versus its Monoproducts (budesonide and formoterol) in Children (.6 Years of Age) and Adults with Asthma – SPRUCE 80/4.5
    Active substance: BUDESONIDE
    Study summary document link (including results):
    View full study record
    Document reference: 22951
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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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