- Trials with a EudraCT protocol (280)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (20)

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: Intranasal and subcutaneous treatment of central precocious puberty in both sexes with a long-acting analog of luteinizing hormone-releasing hormoneIntranasal and subcutaneous treatment of central precocious puberty in both sexes with a long-acting analog of luteinizing hormone-releasing hormone - A.S. Luder et al. - 1984 (J. Clin. Endocrinol. Metab. ; 58: 966) |
Active substance: Buserelin |
Study summary document link (including results): Buserelin STUDY Luder 1984.xls |
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Document reference: 41850 |
Study title: Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Meltzer EO. Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34.Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Meltzer EO. Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34. |
Active substance: BUDESONIDE |
Study summary document link (including results): Clinical and antiinflammatory effects of intranasal budesoni.pdf |
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Document reference: 45090 |
Study title: A comparison of the efficacy and tolerability of budesonide given intranasally as a dry powder (via Turbuhaler) to placebo in children with seasonal allergic rhinitis. |
Active substance: BUDESONIDE |
Study summary document link (including results): 05-3003 Study Synopsis.pdf |
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Document reference: 22969 |
Study title: A comparison of the efficacy and tolerability of budesonide given intranasally as a dry powder (via Turbuhaler) to placebo in children with seasonal allergic rhinitis. |
Active substance: BUDESONIDE |
Study summary document link (including results): 05-2172 Study Synopsis.pdf |
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Document reference: 22985 |
Study title: Single Dose Pharmacokinetics of Intranasal Budesonide (Rhinocort Aqua®) in 2-5 Year-Old Children with Allergic Rhinitis. |
Active substance: BUDESONIDE |
Study summary document link (including results): D5360C03043 Study Synopsis.pdf |
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Document reference: 22978 |
Study title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Long-term Treatment with RHINOCORT AQUA (budesonide) Nasal Spray in Children with Perennial Allergic Rhinitis. Single Dose Pharmacokinetics of Intranasal Budesonide (Rhinocort Aqua®) in 2-5 Year-Old Children with Allergic Rhinitis. |
Active substance: BUDESONIDE |
Study summary document link (including results): D5360C03043 Study Synopsis.pdf |
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Document reference: 22966 |
Study title: Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. BMJ. 2000 Jul 8;321(7253):83-6.Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. BMJ. 2000 Jul 8;321(7253):83-6. |
Active substance: DIAZEPAM |
Study summary document link (including results): |
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Document reference: 25946 |
Study title: Mahmoudian T, Zadeh MM. Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children. Epilepsy Behav. 2004 Apr;5(2):253-5.Mahmoudian T, Zadeh MM. Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children. Epilepsy Behav. 2004 Apr;5(2):253-5. |
Active substance: DIAZEPAM |
Study summary document link (including results): |
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Document reference: 25942 |
Study title: Efficacy and safety of intranasally applied dimetindene maleate solution. Bauer, C.P. and Unkauf, M. (2001) Drug. Res. 51 (1), 232-237 Efficacy and safety of intranasally applied dimetindene maleate solution. Bauer, C.P. and Unkauf, M. (2001) Drug. Res. 51 (1), 232-237 |
Active substance: DIMETINDENE |
Study summary document link (including results): |
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Document reference: 26163 |
Study title: A multicenter, double-blind, randomized, placebo-controlled study to compare concomitant Montelukast and Loratadine with intranasal Beclomethasone in patients with seasonal allergic rhinitis |
Active substance: MONTELUKAST |
Study summary document link (including results): |
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Document reference: 32418 |
Study title: Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. |
Active substance: HYDROXYZINE |
Study summary document link (including results): ADPE96L1314.pdf |
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Document reference: 29285 |
Study title: A double-blind, 2x2 Factohal Study to evaluate the effects of treatment with intranasal fluticasone propionate and use of Otovent mechanical ventilation of the middle ear on the need for surgery in children aged 4-8 with chronic or recurrent otitis media. |
Active substance: FLUTICASONE |
Study summary document link (including results): Study FLNL45-Fluticasone_Flixonase.xls |
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Document reference: 28363 |
Study title: A placebo controlled trial during the pollen season comparing the effects of intranasal Beclomethasone dipropionate and intranasal Fluticasone propionate in children and young adults with asthma and allergic rhinitis. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FNM40054-ICHE3.pdf |
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Document reference: 28366 |
Study title: Lack of effect of erythromycin and ketoconazole on the pharmacokinetics and pharmacodynamics of steady state intranasal levocabastine. Tran J Q, Di Cicco R A, Sheth S B, Tucci M, Peng L, Jorkasky D K, Hursting M J, Benincosa L J. Journal of clinical pharmacology, {May 1999, vol. 39, no. 5, p. 513 9. |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): |
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Document reference: 26441 |
Study title: Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996Comparison of intranasal midazolam and sufentanil premedication pediatric outpatients. Clinical Pharmacology and Therapeutics 59, p. 314-348, 1996 |
Active substance: SUFENTANYL |
Study summary document link (including results): |
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Document reference: 42622 |
Study title: Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470) Ghigo E et al.: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. Journal of Clinical Endocrinology and Metabolism (J. CLIN. ENDOCRINOL. METAB. ) (United States) , May 24, 1991, 72/2 (467-470) |
Active substance: NEOSTIGMINE |
Study summary document link (including results): |
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Document reference: 47052 |
Study title: Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children.Intranasal administration of neostigmine potentiates both intravenous and intranasal growth hormone (GH)-releasing hormone-induced GH release in short children. |
Active substance: NEOSTIGMINE |
Study summary document link (including results): |
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Document reference: 47054 |
Study title: Publication in Rapport d'Expert sur la documentation clinique - Braunstein GL - 17/11/1995 Short-term growth in children with allergic rhinitis treated with oral antihistamine, depot and intranasal glucocorticoids - Wolthers OD - 1993 (Acta Paediatr 82:635-640) |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): |
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Document reference: 46836 |
Study title: Efficacy and safety of intranasally applied dimetindene maleate solution. Multicenter study in children under 14 years suffering from seasonal allergic rhinitisBauer 2001 |
Active substance: PHENYLEPHRINE AND DEMETHINDENE MALEATE |
Study summary document link (including results): 2011-EMA spreadsheet - Vibrocil - Bauer_2001.xls |
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Document reference: 48026 |
Study title: An Open-Label, Repeat Dose, Multicenter Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Intranasally Administered Triamcinolone Acetonide (Nasacort AQ) in Pediatric Allergic Rhinitis Patients 2 to 5 Years of Age Compared to Adult Patients 18 to 50 Years of Age |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone Acetonide-Study 2.pdf |
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Document reference: 46830 |