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Clinical trials for SAFETY

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   44352   clinical trials with a EudraCT protocol, of which   7379   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: 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: Medical report of a double-blind, placebo-controlled, crossover study, to evaluate the efficacy and safety of 3 daily doses of 4 mg BW825C in children (6-13 yrs) exhibiting the symptoms of perennial allergic rhinitis, conducted by Dr. E.G. Weinberg, Cape Town, South Africa. Report No. BRAH/85/0011/00
    Active substance: ACRIVASTIN
    Study summary document link (including results): Study H40-082-C86-Acrivastine.xls
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    Document reference: 46227
    Study title: Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.
    Active substance: ACRIVASTIN
    Study summary document link (including results):
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    Document reference: 46222
    Study title: Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.
    Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE
    Study summary document link (including results):
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    Document reference: 46231
    Study title: Phase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold FormulaPhase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold Formula
    Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE
    Study summary document link (including results):
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    Document reference: 46248
    Study title: A STUDY OF THE EFFICACY AND SAFETY OF ADAPALENE 0.1% AND 0.3% GEL IN THE TREATMENT OF ACTINIC KERATOSES IN ORGAN TRANSPLANT PATIENTS
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46293
    Study title: AN OPEN LABEL, CLINICAL SAFETY AND EFFICACY STUDY OF DIFFERIN (ADAPALENE) GEL IN THE TREATMENT OF FACIAL ACNE VULGARIS IN DARK PIGMENTED SKIN – SOUTH AFRICA
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46261
    Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1 % GEL VERSUS TRETINOIN 0.025 % GEL (WITH PARTICULAR REFERENCE TO ONSET OF ACTION) IN THE TREATMENT OF ACNE VULGARIS
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46253
    Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1% GEL VERSUS ISOTRETINOIN 0.05% GEL IN THE TREATMENT OF ACNE VULGARIS
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46292
    Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1% GEL VERSUS TRETINOIN 0.025% GEL IN THE TREATMENT OF ACNE VULGARIS – PHASE IV – CHINA
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46262
    Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1% GEL VERSUS VEHICLE IN THE TREATMENT OF ACNE VULGARIS – Mexico
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46259
    Study title: CLINICAL STUDY PROTOCOL - EFFICACY AND SAFETY OF ADAPALENE GEL IN TWO CONCENTRATIONS (0.1% AND 0.03%) AND ITS VEHICLE IN THE TREATMENT OF JAPANESE SUBJECTS WITH ACNE VULGARIS
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46289
    Study title: COMPARISON OF EFFICACY AND SAFETY OF TETRALYSAL 300MG PLUS DIFFERIN GEL 0.1% VERSUS TETRALYSAL 300MG PLUS DIFFERIN GEL VEHICLE IN SUBJECTS WITH ACNE VULGARIS
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46285
    Study title: HALF-FACE COMPARISON OF THE SAFETY AND EFFICACY OF DIFFERIN (ADAPALENE GEL) GEL, 0.1% VERSUS TAZORAC (TAZAROTENE GEL) GEL, 0.1% AND RETIN-A MICRO (TRETINOIN GEL) GEL, 0.1% IN SUBJECTS WITH ACNE VULGARIS - PHASE IV
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46272
    Study title: SAFETY AND EFFICACY COMPARISON OF DIFFERIN (ADAPALENE GEL) GEL, 0.1% AND RETIN-A GEL, 0.025% IN THE TREATMENT OF ACNE VULGARIS - PHASE IV
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46267
    Study title: SAFETY AND EFFICACY COMPARISON OF DIFFERIN (ADAPALENE GEL) GEL, 0.1 % VERSUS RETIN-A CREAM, 0.05 % IN SUBJECTS WITH ACNE VULGARIS – PHASE IV
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46258
    Study title: US - A LONG TERM SAFETY AND EFFICACY STUDY OF ADAPALENE GEL, 0,3% IN SUBJECTS WITH ACNE VULGARIS
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46277
    Study title: US - A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO DEMONSTRATE THE EFFICACY AND SAFETY OF ADAPALENE/BENZOYL PEROXIDE TOPICAL GEL COMPARED WITH ADAPALENE TOPICAL GEL, 0.1%; BENZOYL PEROXIDE TOPICAL GEL, 2.5% AND TOPICAL GEL VEHICLE IN SUBJECTS WITH ACNE VULGARIS
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46284
    Study title: US - EFFICACY AND SAFETY OF ADAPALENE GEL, 0.3% COMPARED TO TAZAROTENE GEL, 0.1% IN THE TREATMENT OF ACNE VULGARIS - PHASE IIIB
    Active substance: ADAPALENE
    Study summary document link (including results):
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    Document reference: 46283
    Study title: A phase IV double-blind single dose evaluation of the safety and efficacy of acetaminophen 1000 mg, aspirin 650 mg, and placebo in the treatment of pain following oral surgery.
    Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL
    Study summary document link (including results): acetylsalicylic acid_paracetamol 2-231.pdf
    View full study record
    Document reference: 47205
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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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