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Clinical trials for Dextromethorphan

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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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: Blake MJ, et all. Ontogeny of dextromethorphan O- and N-demethylation in the first year of life. Clin Pharmacol Ther. 2007 Apr;81(4):510-6. Epub 2007 Feb 14.Blake MJ, et all. Ontogeny of dextromethorphan O- and N-demethylation in the first year of life. Clin Pharmacol Ther. 2007 Apr;81(4):510-6. Epub 2007 Feb 14.
    Active substance: BENZILIC ALCOHOL + DEXTROMETHORPHAN
    Study summary document link (including results):
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    Document reference: 22287
    Study title: .Paul IM, et all. Dose-response relationship with increasing doses of dextromethorphan for children with cough. Clin Ther. 2004 Sep;26(9):1508-14.
    Active substance: BENZILIC ALCOHOL + DEXTROMETHORPHAN
    Study summary document link (including results):
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    Document reference: 22289
    Study title: Yoder KE, et all.. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clin Pediatr (Phila). 2006 Sep;45(7):633-40. Yoder KE, et all.. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clin Pediatr (Phila). 2006 Sep;45(7):633-40.
    Active substance: BENZILIC ALCOHOL + DEXTROMETHORPHAN
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    Document reference: 22288
    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
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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
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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
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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
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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
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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
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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
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    Document reference: 23996
    Study title: Leary−P−M et al. Antipyretic effect of oral v. rectal paracetamol. {S−Afr−Med−J}, Dec 1997, vol. 87, no. 12, p. 1708
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23997
    Study title: Lee PCL et al. Antitussive efficacy of dextromethorphan in cough associated with acute upper respiratory tract infection. J Pharm Pharmacol 2000; 52(9):1137-42
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 23998
    Study title: Ulukol−B et al. Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. {EUR−J−CLIN−PHARMACOL}, 1999, Vol/Iss/Pg. 55/9 (615−618
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
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    Document reference: 24016
    Study title: Vauzelle−Kervroedan−F et al. Equivalent antipyretic activity of ibuprofen and paracetamol in febrile children. {J−PEDIATR}, 1997, Vol/Iss/Pg. 131/5 (683−687)
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
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    Document reference: 24017
    Study title: Wahba−H. The Antipyretic Effect of Ibuprofen and Acetaminophen in Children. {PHARMACOTHERAPY}, 2004, Vol/Iss/Pg. 24/2 I (280−284)
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
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    Document reference: 24018
    Study title: Walson−P−D et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. {AM−J−DIS−CHILD}, 1992, Vol /Iss/Pg. 146/5 (626−632)
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 24019
    Study title: Walson−P−D et al. Ibuprofen, acetaminophen, and placebo treatment of febrile children. {Clin−Pharmacol−Ther}, Jul 1989, vol. 46, no. 1, p. 9−17
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 24020
    Study title: Walson−P−D. Ibuprofen versus paracetamol for the treatment of fever in children. {BR−J−CLIN−PRACT}, 1990, Vol/Iss /Pg. 44/8 SUPPL. 70 (19−21)
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 24021
    Study title: Weisse−M−E et al. Fever response to acetaminophen in viral vs. bacterial infections. {Pediatr−Infect−Dis−J}, Dec 1987, vol. 6, no. 12, p. 1091−4
    Active substance: CHLORPHENIRAMINE + DEXTROMETHORPHAN + PARACETAMOL
    Study summary document link (including results):
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    Document reference: 24022
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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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