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Clinical trials for AIF

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.
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    Study title: A randomized clinical trial to compare the efficacy of erythromycin, ampicillin and tetracycline for the treatment of cholera in children. Roy S K, Islam A, Ali R, Islam K E, Khan R A, Ara S H, Saifuddin N M, Fuchs G J. Transactions of the Royal Society of Tropical Medicine and Hygiene, Jul Aug 1998, vol. 92, no. 4, p. 460 2.
    Active substance: ERYTHROMYCIN
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    Document reference: 26446
    Study title: Electrocardiographic Findings in Patients with Diphenhydramine Overdose, Zareba, W., Am. J. Cardiol. 1997; 80: 1168-1173Electrocardiographic Findings in Patients with Diphenhydramine Overdose, Zareba, W., Am. J. Cardiol. 1997; 80: 1168-1173
    Active substance: DIPHENHYDRAMINE AND GUAIFENESIN AND L-MENTHOL
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    Document reference: 26175
    Study title: Outcome of prophylactic therapy for idiopathic anaphylaxis, Wong, S., Ann. Intern. Med. 1991; 114: 133-136Outcome of prophylactic therapy for idiopathic anaphylaxis, Wong, S., Ann. Intern. Med. 1991; 114: 133-136
    Active substance: DIPHENHYDRAMINE AND GUAIFENESIN AND L-MENTHOL
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    Document reference: 26174
    Study title: Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.
    Active substance: DIPHENHYDRAMINE AND GUAIFENESIN AND L-MENTHOL
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    Document reference: 26180
    Study title: Russo−R−M, Gururaj−V−J, Allen−J−E. The effectiveness of diphenhydramine HCI in pediatric sleep disorders. Journal of clinical pharmacology, {J−Clin−Pharmacol}, May−Jun 1976, vol. 16, no. 5−6, p. 284−8.Russo−R−M, Gururaj−V−J, Allen−J−E. The effectiveness of diphenhydramine HCI in pediatric sleep disorders. Journal of clinical pharmacology, {J−Clin−Pharmacol}, May−Jun 1976, vol. 16, no. 5−6, p. 284−8.
    Active substance: DIPHENHYDRAMINE AND GUAIFENESIN AND L-MENTHOL
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    Document reference: 26177
    Study title: Kuhn−J−J, Hendley−J−O, Adams−K−F, Clark−J−W, Gwaltney−J−M−Jr. Antitussive effect of guaifenesin in young adults with natural colds. Objective and subjective assessment. Chest, {Chest}, Dec 1982, vol. 82, no. 6, p. 713−8.Kuhn−J−J, Hendley−J−O, Adams−K−F, Clark−J−W, Gwaltney−J−M−Jr. Antitussive effect of guaifenesin in young adults with natural colds. Objective and subjective assessment. Chest, {Chest}, Dec 1982, vol. 82, no. 6, p. 713−8.
    Active substance: DIPHENHYDRAMINE AND MENTHOL
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    Document reference: 26181
    Study title: Korppi M et al. Antitussives in the treatment of acute transient cough in children. Acta Paediatr Scand 1991; 80(10):969-71Korppi M et al. Antitussives in the treatment of acute transient cough in children. Acta Paediatr Scand 1991; 80(10):969-71
    Active substance: GUAIFENESIN
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    Document reference: 29027
    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):1137-42Lee 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: GUAIFENESIN
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    Document reference: 29028
    Study title: Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308. Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.
    Active substance: GUAIFENESIN
    Study summary document link (including results):
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    Document reference: 45237
    Study title: Kuhn−J−J, Hendley−J−O, Adams−K−F, Clark−J−W, Gwaltney−J−M−Jr. Antitussive effect of guaifenesin in young adults with natural colds. Objective and subjective assessment. Chest, {Chest}, Dec 1982, vol. 82, no. 6, p. 713−8.Kuhn−J−J, Hendley−J−O, Adams−K−F, Clark−J−W, Gwaltney−J−M−Jr. Antitussive effect of guaifenesin in young adults with natural colds. Objective and subjective assessment. Chest, {Chest}, Dec 1982, vol. 82, no. 6, p. 713−8.
    Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE
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    Document reference: 29052
    Study title: Latte J & Taverner D. Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5Latte J & Taverner D. Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. Am J Rhinol 2007; 21(4):452-5
    Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE
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    Document reference: 29041
    Study title: Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.
    Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE
    Study summary document link (including results):
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    Document reference: 29051
    Study title: Paul IM et al. Dose-response relationship with increasing doses of dextromethorphan for children with cough. Clin Ther 2004; 26(9):1508-1514 Paul IM et al. Dose-response relationship with increasing doses of dextromethorphan for children with cough. Clin Ther 2004; 26(9):1508-1514
    Active substance: GUAIFENESIN
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    Document reference: 29029
    Study title: Paul IM et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics 2004; 114(1):85-90 Paul IM et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics 2004; 114(1):85-90
    Active substance: GUAIFENESIN
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    Document reference: 29030
    Study title: Paul IM et al. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med 2007; 161(12):1140-1146Paul IM et al. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med 2007; 161(12):1140-1146
    Active substance: GUAIFENESIN
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    Document reference: 29031
    Study title: Taylor AJ et al. Efficacy of cough suppressants in children. J Pediatr 1993; 122(5 Pt 1):799-802 Taylor AJ et al. Efficacy of cough suppressants in children. J Pediatr 1993; 122(5 Pt 1):799-802
    Active substance: GUAIFENESIN
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    Document reference: 29032
    Study title: Yoder KE et al. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clin Pediatr 2006; 45(7):633-640Yoder KE et al. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clin Pediatr 2006; 45(7):633-640
    Active substance: GUAIFENESIN
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    Document reference: 29033
    Study title: Bjerre I, Blennow G. Methocarbamol in the treatment of cerebral palsy in children. Neuropadiatrie. 1971 Oct;3(2):140-6.Bjerre I, Blennow G. Methocarbamol in the treatment of cerebral palsy in children. Neuropadiatrie. 1971 Oct;3(2):140-6.
    Active substance: GUAIFENESIN AND CHLOROCYCLINE
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    Document reference: 29038
    Study title: Chakrabarti A, Pandhi P, Jindal SK, Malik SK, Sharma PL. A comparative randomized doubleblind clinical trial of hexapneumine and clistine as antitussive agents. Int J Clin Pharmacol Ther Toxicol. 1987 Jun;25(6):310-2.Chakrabarti A, Pandhi P, Jindal SK, Malik SK, Sharma PL. A comparative randomized doubleblind clinical trial of hexapneumine and clistine as antitussive agents. Int J Clin Pharmacol Ther Toxicol. 1987 Jun;25(6):310-2.
    Active substance: GUAIFENESIN AND CHLOROCYCLINE
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    Document reference: 29035
    Study title: Falliers CJ, Cato AE, Harris JR. Controlled assessment of oral bronchodilators for asthmatic children. J Int Med Res. 1978;6(4):326-36.Falliers CJ, Cato AE, Harris JR. Controlled assessment of oral bronchodilators for asthmatic children. J Int Med Res. 1978;6(4):326-36.
    Active substance: GUAIFENESIN AND CHLOROCYCLINE
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    Document reference: 29036
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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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