- Trials with a EudraCT protocol (123)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (344)

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: A trial of Methyl Polysiloxane in the treatment of abdominal distension - Marks IN - 1965 (S.A. Med. J. 1965; 476-478) - Publication in Part IC3 of the FLATUNYL french dossier 1999 (MAALOX plus) - Bergmann JF - 06/01/1999 -A trial of Methyl Polysiloxane in the treatment of abdominal distension - Marks IN - 1965 (S.A. Med. J. 1965; 476-478) - Publication in Part IC3 of the FLATUNYL french dossier 1999 (MAALOX plus) - Bergmann JF - 06/01/1999 - |
Active substance: ALGELDRATE + MAGNESIUM HYDROXIDE + SIMETICONE/ ALDEGRATE+ MAGNESIUM HYDROXIDE |
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Document reference: 46404 |
Study title: Studie mit Hydro-, Lipo- und Sebonorm Cordes |
Active substance: Allantoin/ Dexpanthenol/Ethyl[(Z/Z)-octadeca-9,12-dienoat] |
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Document reference: 39778 |
Study title: Therapieerfahrungen mit Arnika und Hydroxyethylsalicylat in einem Akut-Spray |
Active substance: ARNICA AND SALICYLIC ACID |
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Document reference: 21831 |
Study title: A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented with Either Extended-Release Methylphenidadte Hydrochloride (Concentra) or Plcebo in Children with Attention-Deficit/Hypractivity Disorder (ADHD) Who Have Not Reponded to Stimula |
Active substance: ATOMOXETINE |
Study summary document link (including results): atomoxetine B4Z-MC-LYBU Clinical study Summary.pdf |
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Document reference: 21990 |
Study title: A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride, Extended-Release Methylphenidate Hydrochloride (Concentra), and Placebo in Pediatric Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder |
Active substance: ATOMOXETINE |
Study summary document link (including results): atomoxetine B4Z-MC-LYBI - clinical study summary.pdf |
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Document reference: 21971 |
Study title: A Randomized, Double-Blind Comparison, Safety and Efficacy Trial of Atomoxetine Hydrochloride and Methylphenidate Hydrochloride in Pediatric Outpaitents with DSM-IV Attention-Deficit/Hypderactivity Disorder |
Active substance: ATOMOXETINE |
Study summary document link (including results): atomoxetine B4Z-MC-LYBR - clinical study summary.pdf |
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Document reference: 21974 |
Study title: Children's Cancer Group 1962 Study : A randomized comparison of native E.coli asparaginase and polyethylene glycol asparaginase for treatment of children ith newly diagnosed standard-risk ALL |
Active substance: ASPARAGINASE |
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Document reference: 21940 |
Study title: A Double-Blind Crossover Study of Atomoxetine Hydrochloride and Methylphenidate Effects on Neural Acticity in Attention-Deficit/Hyperactiviity Disorder |
Active substance: ATOMOXETINE |
Study summary document link (including results): atomoxetine B4Z-MC-LYAU - clinical study summary.pdf |
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Document reference: 21987 |
Study title: Presynaptic catecholamine antagonists as treatment for Tourette syndrome. Effects of alpha methyl para tyrosine and tetrabenazine. |
Active substance: BENZATROPINE |
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Document reference: 22252 |
Study title: Presynaptic catecholamine antagonists as treatment for Tourette syndrome. Effects of alpha methyl para tyrosine and tetrabenazine. |
Active substance: BENZATROPINE |
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Document reference: 41956 |
Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in childrenClinical efficacy and tolerance of bacampicillin and amoxycillin suspensions in children with acute otitis media; J Int Med Res. 1989 Jan-Feb;17(1):41-7. |
Active substance: BENZATHINE BENZYLPENICILLIN |
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Document reference: 22276 |
Study title: Randomized, multicenter pilot study comparing the efficacy of potassium-phenoxymethylpenicillin granules for oral suspension 100.000 IU /kg/day tid for 10 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 7 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in childrenEffect on urogenital flora of antibiotic therapy for urinary tract infection; Scand J Infect Dis. 1990;22(1):43-7. |
Active substance: BENZATHINE BENZYLPENICILLIN |
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Document reference: 22275 |
Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyn |
Active substance: BENZATHINE PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): DV 2-99_Final Report_010531.pdf |
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Document reference: 41960 |
Study title: Randomized, multicenter pilot study comparing the efficacy of potassium-phenoxymethylpenicillin granules for oral suspension 100.000 IU /kg/day tid for 10 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 7 days versus b |
Active substance: BENZATHINE PHENOXYMETHYLPENICILLIN |
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Document reference: 41959 |
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: Lehnert-W, Niederhoff-H, Junker-A, Saule-H, Frasch-W. A case of biotin-responsive 3-methylcrotonylglycin- and 3-hydroxyisovaleric aciduria. European journal of pediatrics, {Eur-J-Pediatr}, Oct 1979, vol. 132, no. 2, p. 107-14, ISSN: 0340-6199.Lehnert-W, Niederhoff-H, Junker-A, Saule-H, Frasch-W. A case of biotin-responsive 3-methylcrotonylglycin- and 3-hydroxyisovaleric aciduria. European journal of pediatrics, {Eur-J-Pediatr}, Oct 1979, vol. 132, no. 2, p. 107-14, ISSN: 0340-6199. |
Active substance: BIOTIN |
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Document reference: 22666 |
Study title: Friebel-D, von-der-Hagen-M, Baumgartner-E-R, Fowler-B, Hahn-G, Feyh-P, Heubner-G, Baumgartner-M-R, Hoffmann-G-F. Department of Neuropaediatrics, Children's Hospital, Technical University of Dresden, Dresden, Germany. The first case of 3-methylcrotonyl-CoA carboxylase (MCC) deficiency responsive to biotin. Neuropediatrics, {Neuropediatrics}, Apr 2006, vol. 37, no. 2, p. 72-8, ISSN: 0174-304X.Friebel-D, von-der-Hagen-M, Baumgartner-E-R, Fowler-B, Hahn-G, Feyh-P, Heubner-G, Baumgartner-M-R, Hoffmann-G-F. Department of Neuropaediatrics, Children's Hospital, Technical University of Dresden, Dresden, Germany. The first case of 3-methylcrotonyl-CoA carboxylase (MCC) deficiency responsive to biotin. Neuropediatrics, {Neuropediatrics}, Apr 2006, vol. 37, no. 2, p. 72-8, ISSN: 0174-304X. |
Active substance: BIOTIN |
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Document reference: 22595 |
Study title: Gompertz-D, Draffan-G-H, Watts-J-L, Hull-D. The Journal of pediatrics, {J-Pediatr}, Jul 1972, vol. 81, no. 1, p. 39-44, ISSN: 0022-3476. Biotin-responsive beta-methylcrotonylglycinuria. Lancet, {Lancet}, 3 Jul 1971, vol. 2, no. 7714, p. 22-4, ISSN: 0140-6736.Gompertz-D, Draffan-G-H, Watts-J-L, Hull-D. The Journal of pediatrics, {J-Pediatr}, Jul 1972, vol. 81, no. 1, p. 39-44, ISSN: 0022-3476. Biotin-responsive beta-methylcrotonylglycinuria. Lancet, {Lancet}, 3 Jul 1971, vol. 2, no. 7714, p. 22-4, ISSN: 0140-6736. |
Active substance: BIOTIN |
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Document reference: 22672 |
Study title: Bartlett-K, Ng-H, Leonard-J-V. A combined defect of three mitochondrial carboxylases presenting as biotin-responsive 3-methylcrotonyl glycinuria and 3-hydroxyisovaleric aciduria. Clinica chimica acta; international journal of clinical chemistry, {Clin-Chim-Acta}, 15 Jan 1980, vol. 100, no. 2, p. 183-6, ISSN: 0009-8981.Bartlett-K, Ng-H, Leonard-J-V. A combined defect of three mitochondrial carboxylases presenting as biotin-responsive 3-methylcrotonyl glycinuria and 3-hydroxyisovaleric aciduria. Clinica chimica acta; international journal of clinical chemistry, {Clin-Chim-Acta}, 15 Jan 1980, vol. 100, no. 2, p. 183-6, ISSN: 0009-8981. |
Active substance: BIOTIN |
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Document reference: 22662 |
Study title: Baumgartner-Matthias-R, Dantas-M-Fernanda, Suormala-Terttu, Almashanu-Shlomo, Giunta-Cecilia, Friebel-Dolores, Gebhardt-Boris, Fowler-Brian, Hoffmann-Georg-F, Baumgartner-E-Regula, Valle-David. Division of Metabolism and Molecular Pediatrics, University Children's Hospital, Zurich, Switzerland.. Isolated 3-methylcrotonyl-CoA carboxylase deficiency: evidence for an allele-specific dominant negative effect and responsiveness to biotin therapy. American journal of human genetics, {Am-J-Hum-Genet}, Nov 2004 (epub: 09 Sep 2004), vol. 75, no. 5, p. 790-800, ISSN: 0002-9297.Baumgartner-Matthias-R, Dantas-M-Fernanda, Suormala-Terttu, Almashanu-Shlomo, Giunta-Cecilia, Friebel-Dolores, Gebhardt-Boris, Fowler-Brian, Hoffmann-Georg-F, Baumgartner-E-Regula, Valle-David. Division of Metabolism and Mo... |
Active substance: BIOTIN |
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Document reference: 22598 |