- Trials with a EudraCT protocol (25)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)

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: 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Document reference: 24022 |