- Trials with a EudraCT protocol (436)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (478)

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: 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 |
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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 |
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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 Protocol 9-106, Unpublished Report 136.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 Protocol 3-251, Unpublished Report 157.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 |
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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 |