- Trials with a EudraCT protocol (198)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (58)

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: Ballmer−Weber−B−K, Gex−Collet−C, Wüthrich−B. Inhibition of histamine or allergen−induced wheals by a single dose of acrivastine, fexofenadine or cetirizine. Journal of investigational allergology & clinical immunology : official organ of the International Association of Asthmology (INTERASMA) and Sociedad Latinoamericana de Alergia e Inmunología, Nov−Dec 1999, vol. 9, no. 6, p. 351−5.Ballmer−Weber−B−K, Gex−Collet−C, Wüthrich−B. Inhibition of histamine or allergen−induced wheals by a single dose of acrivastine, fexofenadine or cetirizine. Journal of investigational allergology & clinical immunology : official organ of the International Association of Asthmology (INTERASMA) and Sociedad Latinoamericana de Alergia e Inmunología, Nov−Dec 1999, vol. 9, no. 6, p. 351−5. |
Active substance: ACRIVASTIN |
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Document reference: 46229 |
Study title: Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142. |
Active substance: ACRIVASTIN |
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Document reference: 46222 |
Study title: Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142. |
Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE |
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Document reference: 46231 |
Study title: Clinical evaluation of a new antihistamine, buclizine hydrochloride (vibrazine). |
Active substance: Buclizine |
Study summary document link (including results): DE55G261P - Buclizine hydrochloride.pdf |
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Document reference: 42009 |
Study title: Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with over-the counter antihistamines, ibuprofen and clemasine, Pratt, C.M., Am. J. Cardiol. 1994; 73: 346-352Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with over-the counter antihistamines, ibuprofen and clemasine, Pratt, C.M., Am. J. Cardiol. 1994; 73: 346-352 |
Active substance: CAFFEINE AND DIMENHYDRINATE |
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Document reference: 23119 |
Study title: Sedation and performance impairment of diphenhydramine and secon-generation antihistamines: a meta-analysis, Bender, B.G., J. Allergy Clin. Immunol. 2003; 111:770-776Sedation and performance impairment of diphenhydramine and secon-generation antihistamines: a meta-analysis, Bender, B.G., J. Allergy Clin. Immunol. 2003; 111:770-776 |
Active substance: CAFFEINE AND DIMENHYDRINATE |
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Document reference: 23102 |
Study title: Evaluation of the potential cardiotoxicity of the antihistamines terfenadine, astemizole, loratadine, and cetirizine in atopic children. Delgado L F, Pferferman A, Solé D, Naspitz C K. Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, Apr 1998, vol. 80, no. 4, p. 333 7. |
Active substance: ERYTHROMYCIN |
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Document reference: 26452 |
Study title: Prevention and treatment of serous otitis media with an oral antihistamine. A double−blind study in pediatric practice.Klein S W, Olson A L, Perrin J, Cunningham D, Hengerer A, Hoekelman R A, Roghmann K J. Clinical pediatrics, {Clin−Pediatr−Phila}, May 1980, vol. 19, no. 5, p. 342−7, ISSN: 0009−9228. |
Active substance: ERYTHROMYCIN |
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Document reference: 26540 |
Study title: Do antihistamines impair school performance in children? Marsland TW, Newton WP. J Fam Pract. 2001 Sep;50(9):738. No abstract available.Do antihistamines impair school performance in children? Marsland TW, Newton WP. J Fam Pract. 2001 Sep;50(9):738. No abstract available. |
Active substance: DIPHENHYDRAMINE_OR DIPHENHYDRAMINE AND CHLORHEXIDINE |
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Document reference: 26199 |
Study title: Marsland TW, Newton WP Do antihistamines impair school performance in children? . J Fam Pract. 2001 Sep;50(9):738. No abstract available.Marsland TW, Newton WP Do antihistamines impair school performance in children? . J Fam Pract. 2001 Sep;50(9):738. No abstract available. |
Active substance: DIPHENHYDRAMINE_OR DIPHENHYDRAMINE AND CHLORHEXIDINE |
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Document reference: 26191 |
Study title: Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with over-the counter antihistamines, ibuprofen and clemasine, Pratt, C.M., Am. J. Cardiol. 1994; 73: 346-352Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with over-the counter antihistamines, ibuprofen and clemasine, Pratt, C.M., Am. J. Cardiol. 1994; 73: 346-352 |
Active substance: DIPHENHYDRAMINE_OR DIPHENHYDRAMINE AND CHLORHEXIDINE |
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Document reference: 26219 |
Study title: Seasonal allergic rhinitis and antihistamine effects on children's learning. Vuurman EF, van Veggel LM, Uiterwijk MM, Leutner D, O'Hanlon JF. Ann Allergy. 1993 Aug;71(2):121-6.Seasonal allergic rhinitis and antihistamine effects on children's learning. Vuurman EF, van Veggel LM, Uiterwijk MM, Leutner D, O'Hanlon JF. Ann Allergy. 1993 Aug;71(2):121-6. |
Active substance: DIPHENHYDRAMINE_OR DIPHENHYDRAMINE AND CHLORHEXIDINE |
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Document reference: 26200 |
Study title: Sedation and performance impairment of diphenhydramine and secon-generation antihistamines: a meta-analysis, Bender, B.G., J. Allergy Clin. Immunol. 2003; 111:770-776Sedation and performance impairment of diphenhydramine and secon-generation antihistamines: a meta-analysis, Bender, B.G., J. Allergy Clin. Immunol. 2003; 111:770-776 |
Active substance: DIPHENHYDRAMINE_OR DIPHENHYDRAMINE AND CHLORHEXIDINE |
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Document reference: 26207 |
Study title: N. Huberman (1962) Clinical evaluation of an effective, new antihistamine, dimethpyrindene maleate. Medical times, 7, 725-727. N. Huberman (1962) Clinical evaluation of an effective, new antihistamine, dimethpyrindene maleate. Medical times, 7, 725-727. |
Active substance: DIMETINDENE |
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Document reference: 26161 |
Study title: USPDI Parenteral Dosage Forms, Antihistamines (Systemic) Diphenhydramine Hydrochloride Injection USP, United States Pharmacopoeia Dispensing InformationUSPDI Parenteral Dosage Forms, Antihistamines (Systemic) Diphenhydramine Hydrochloride Injection USP, United States Pharmacopoeia Dispensing Information |
Active substance: DIPHENHYDRAMINE_OR DIPHENHYDRAMINE AND CHLORHEXIDINE |
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Document reference: 26225 |
Study title: Vuurman EF, van Veggel LM, Uiterwijk MM, Leutner D, O'Hanlon JF. Seasonal allergic rhinitis and antihistamine effects on children's learning. Ann Allergy. 1993 Aug;71(2):121-6Vuurman EF, van Veggel LM, Uiterwijk MM, Leutner D, O'Hanlon JF. Seasonal allergic rhinitis and antihistamine effects on children's learning. Ann Allergy. 1993 Aug;71(2):121-6 |
Active substance: DIPHENHYDRAMINE_OR DIPHENHYDRAMINE AND CHLORHEXIDINE |
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Document reference: 26192 |
Study title: A Comparison of Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine |
Active substance: FEXOFENADINE |
Study summary document link (including results): Fexofenadine - Study 9.pdf |
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Document reference: 45687 |
Study title: A study of an antihistamine with delayed action in the treatment of pruritic dermatoses |
Active substance: Buclizine |
Study summary document link (including results): ADPE95H2410-translation.pdf |
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Document reference: 42011 |
Study title: Clinical evaluation of a new antihistamine, buclizine hydrochloride |
Active substance: Buclizine |
Study summary document link (including results): CE61E151.pdf |
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Document reference: 42012 |
Study title: Evaluation of the potential cardiotoxicity of the antihistamines terfenadine, astemizole, loratadine, and cetirizine in atopic children |
Active substance: CETIRIZINE |
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Document reference: 23688 |