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Clinical trials for Paracetamol

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   44349   clinical trials with a EudraCT protocol, of which   7376   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 ).  
     
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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: 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 phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Stat Rpt 32. Protocol 9-106, Unpublished Report 136.
    Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL
    Study summary document link (including results): acetylsalicylic acid_paracetamol 9-106.pdf
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    Document reference: 47203
    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
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    Document reference: 47205
    Study title: A phase IV double-blind single dose study of the efficacy and safety of acetaminophen 1000 mg, aspirin 1000 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 45. Protocol 3-251, Unpublished Report 157.
    Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL
    Study summary document link (including results): acetylsalicylic acid_paracetamol 3-251.pdf
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    Document reference: 47204
    Study title: A phase IV double-blind single dose study of the safety and efficacy of acetaminophen 1000 mg, Gemnisyn® 1300 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 1-220.pdf
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    Document reference: 47207
    Study title: Phase IV Double-Blind Single Dose Study 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 1-229.pdf
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    Document reference: 47206
    Study title: phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, choline salicylate and placebo in febrile children.
    Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL AND CHOLINE SALICYLATE
    Study summary document link (including results): acetylsalicylic acid_choline salicylate_paracetamol 118.pdf
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    Document reference: 47208
    Study title: A Randomized, Double-Blind Multicenter Study of the Efficacy and Safety of Tylenol® Allergy Sinus (AS) Compared with Claritin® in the Treatment of Seasonal Allergic Rhinitis
    Active substance: CHLORPHENIRAMINE + PARACETAMOL+PSEUDOEPHEDRINE
    Study summary document link (including results): chlorpheniramine_paracetamol_pseudoephedrine 97-033.pdf
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    Document reference: 47426
    Study title: A Randomized, Double-Blind Multicenter Study of the Efficacy and Safety of Tylenol® Allergy Sinus (AS) Compared with Claritin® in the Treatment of Seasonal Allergic Rhinitis
    Active substance: CHLORPHENIRAMINE + PARACETAMOL+PSEUDOEPHEDRINE
    Study summary document link (including results): chlorpheniramine_paracetamol_pseudoephedrine 97-034.pdf
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    Document reference: 47427
    Study title: An Evaluation of the Efficacy and Safety of C-9-7 Cold Formula in Pediatric Patients with Symptomatology of Upper Respiratory Infection or Allergic Rhinitis. Report 113.
    Active substance: CHLORPHENIRAMINE + PARACETAMOL+PSEUDOEPHEDRINE
    Study summary document link (including results): chlorpheniramine_paracetamol_pseudoephedrine 113.pdf
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    Document reference: 47428
    Study title: Phase IV Efficacy and Safety Study of Reformulated CoTylenol Tablets. Unpublished Report TA5
    Active substance: CHLORPHENIRAMINE + PARACETAMOL+PSEUDOEPHEDRINE
    Study summary document link (including results): chlorpheniramine_paracetamol_pseudoephedrine TA5.pdf
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    Document reference: 47429
    Study title: Götte−R, Liedtke−R. (On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application (author's transl)). {Med−Klin}, 6 Jan 1978, vol. 73, no. 1, p. 28−33
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23989
    Study title: Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23990
    Study title: Joshi−Y−M et al. Comparative evaluation of the antipyretic efficacy of ibuprofen and paracetamol. {Indian−Pediatr}, Aug 1990, vol. 27, no. 8, p. 803−6
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23991
    Study title: Kapoor−S−K et al. Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. {INDIAN−PEDIATR}, 2002, Vol/Iss/Pg. 39/5 (473−477)
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23992
    Study title: Kauffman−R−E et al. Antipyretic efficacy of ibuprofen vs acetaminophen. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (622−625)
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23993
    Study title: Korppi M et al. Antitussives in the treatment of acute transient cough in children. Acta Paediatr Scand 1991; 80(10):969-71
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23994
    Study title: Kramer−M−S et al. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. {Lancet}, 9 Mar 1991, vol. 337, no. 8741, p. 591−4
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23995
    Study title: Lal−A et al. Antipyretic effects of nimesulide, paracetamol and ibuprofen− paracetamol. {INDIAN−J−PEDIATR}, 2000, Vol/Iss/Pg. 67 /12 (865−870)
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23996
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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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