- Trials with a EudraCT protocol (123)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (344)
Query did not match any clinical trials.
| 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 |
| Study summary document link (including results): |
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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] |
| Study summary document link (including results): |
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| Document reference: 39778 |
| Study title: Therapieerfahrungen mit Arnika und Hydroxyethylsalicylat in einem Akut-Spray |
| Active substance: ARNICA AND SALICYLIC ACID |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |
| Study summary document link (including results): |
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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 |