- Trials with a EudraCT protocol (320)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (10)

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: Sleep disordered breathing and daytime quality of life |
Active substance: BUDESONIDE |
Study summary document link (including results): Sleep disordered breathing and daytime quality of life in ch.pdf |
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Document reference: 47748 |
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. |
Active substance: Dextromethorphan + Diphenhydramine + L-Menthol + Pseudoephedrine |
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Document reference: 25905 |
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: Habre-Analgesic and respiratory effect of nalbuphine and pethidine for adenotonsillectomy in children with obstructive sleep disorder. |
Active substance: NALBUPHINE |
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Document reference: 32451 |
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. |
Active substance: CODEINE_AND_DIPHENHYDRAMINE_AND_L-MENTHOL |
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Document reference: 24482 |
Study title: Post-marketing surveillance study on the treatment of restlessness and nervous sleep disorder in children under 14 years of age (Euvegal® forte) |
Active substance: HERB: dry extract from Valerian root (3 - 6 : 1), extraction agent: ethanol 62 % (w/w); dry extract from Balm leaves (4 - 6 : 1), extraction agent: ethanol 30 % (w/w)./ HERB: dry extract from Valerian root (4 - 5 : 1), dry extract from Balm leaves (4 - 6 : 1)./ HERB: Extract of Valerian root, corresp. to 640-800 mg drug; + Extract of Melissa leaf, corresp. 60 320-480 mg drug./ HERB: dry extract... |
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Document reference: 21221 |
Study title: Sleep disorders in Children. Observational study with a high dosage valerian extract.; Hintelmann C. Schweiz. Z. Ganzheitsmed. 2002;14( ): 404-407 |
Active substance: (HERB) Valeriana officinalis L. extract |
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Document reference: 39724 |
Study title: Reimão R, Lefévre AB.: Evaluation of flurazepam and placebo on sleep disorders in childhood. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13. |
Active substance: FLURAZEPAM |
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Document reference: 28345 |
Study title: VALUTAZIONE IN PEDIATRIA DELL'ATTIVITA' IPNOINDUCENTE DEL FLURAZEPAM GOCCE (VAL 779) Rapisarda V.; Germana B. Formazione Psichiatrica, December 1, 1980 , No. 4/- (181-190) Evaluation of flurazepam and placebo on sleep disorders in childhood. Reimão R, Lefévre AB. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13. |
Active substance: FLURAZEPAM |
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Document reference: 28344 |
Study title: "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " |
Active substance: PRAZEPAM |
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Document reference: 34643 |