- Trials with a EudraCT protocol (310)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)

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: Somatostatin receptor subtype 2 is expressed by supratentorial primitive neuroectodermal tumors of childhood and can be targeted for somatostatin receptor imaging : Frühwald MC, Rickert CH, O'Dorisio MS, Madsen M, Warmuth-Metz M, Khanna G, Paulus W, Kühl J, Jürgens H, Schneider P, Müller HL; Clin Cancer Res. 2004 May 1;10(9):2997-3006 |
Active substance: (111In) INDIUM CHLORIDE/PENTETREOTIDE |
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Document reference: 21232 |
Study title: Patients with seasonal allergic rhinitis, conjunctivitis and possobly asthma symptoms so far only statistical analysis, Publication sheduled. Age of patients: 5 - 79 Years |
Active substance: 158 Rye |
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Document reference: 39753 |
Study title: ACARBOSE (BAY G 5421) IN INSULIN-DEPENDENT DIABETES - THE EFFECT ON THE DAILY BLOOD-GLUCOSE PROFILE AND ON THE INSULINCONSUMPTION BY AN ARTIFICIAL PANCREAS (STUDY 0160)(PH-9873) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0160_study_synopsis.pdf |
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Document reference: 46154 |
Study title: Clinical Study on the Efficacy and Tolerability of Acarbose (BAY g 5421) Compared with Placeboin Diabetic Children on Conventional Insulin Treatment, in Particular with Observation of the Glycemic Control Index ( PH-24820 ) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0665_study_synopsis.pdf |
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Document reference: 46158 |
Study title: Double-Blind, Cross-Over Clinical Study at a Single Centre to Compare Acarbose (BAY g 5421) with Placebo in Respect of Efficacy and Tolerability in Patients with Cystic Fibrosis and Pathological Glucose Tolerance (Pilot Study)(PH-26068) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0696_study_synopsis.pdf |
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Document reference: 46159 |
Study title: Blockers and hypoglycaemia (assesment of cadioselective and intrinsic sympathometic properties in relation to severity of hypoglycaemia - No author - 1984 (Current Therapeutic Research 36, n° 2, p. 361-373) ; - Publication in Documentation clinique du dossier d'AMM du 30/10/1987 - |
Active substance: ACEBUTOLOL |
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Document reference: 46182 |
Study title: Clinical and echocardiographic (echo) long-term follow-up of children with severe hypertension (HT) - Loirat C. et al. - No date (Hopital Bretonneau, INSERM U 120, Paris) ; - Publication in Documentation clinique du dossier d'AMM du 30/10/1987 - |
Active substance: ACEBUTOLOL |
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Document reference: 46183 |
Study title: Propanolol as an antihypertensive agent in children - Griswold W.R., Moneal R., Mendoza S.A. et al. - 1978 (Arch. Dis. Child. 537. pp 594-596) - Publication in Expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 - |
Active substance: ACEBUTOLOL |
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Document reference: 46189 |
Study title: Spectral enfant – solution buvable à 40mg/ml – renseignements particuliers – partie V - No author - 01/10/1987 |
Active substance: ACEBUTOLOL |
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Document reference: 46193 |
Study title: Tolérance de 5 jours par voie orale chez le raton et le rat adulte suivie d’une période sans traitement de 15 jours (documentation toxicologique du dossier d’AMM du 30/10/87 du spectral enfant solution buvable 40mg/ml) - Briffaux - 02/10/1987 |
Active substance: ACEBUTOLOL |
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Document reference: 46194 |
Study title: Solcoderm study 006-I1: A double blind clinical comparison of Solcoderm with plain nitric acid of similar acid strnght." M. Weiner, Cincinatti, 1981, Solco-Study A clinical trial with Solcoderm, Authors: Haim S., Cohen A., Dec 1979, Israeli Study (summary) |
Active substance: ACETIC ACID_OXALIC ACID_NITRIC ACID_LACTIC ACID_COPPER (II) NITRATE |
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Document reference: 21248 |
Study title: Solcoderm study 006-I2: "A double-blind evaluation of Solcoderm variants using pairs of comparable skin tumors." |
Active substance: ACETIC ACID_OXALIC ACID_NITRIC ACID_LACTIC ACID_COPPER (II) NITRATE |
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Document reference: 21249 |
Study title: Action antipyrétique de l'acétylsalicylate de lysine (essai comparatif randomisé de trois posologies chez le jeune enfant) - JC Rolland, J. Papoin, C. Maurage, B. Caurier-1986 - Publication in the report N° FILIRF-FRZ0069-EN-E01 - |
Active substance: ACETYL SALICYLIC ACID |
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Document reference: 46165 |
Study title: Etude de l'absorption de l' "aspégic enfants nourissons" selon les modalités d'administration par voie orale - C. Dubray, A. Labbe, EJ Raynaud, M. Paire, J. Lavarenne - 1983 - Publication in the report N° FILIRF-FRZ0069-EN-E01 - |
Active substance: ACETYL SALICYLIC ACID |
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Document reference: 46172 |
Study title: Evaluation of ibuprofen versus Aspirin and Paracetamol on efficacy and comfort in children with fever - E. Autret, J. Reboul-Marty, B. Henry-Launois, C. Laborde, S. Courcier, JM Goehrs, G. Languillat, R. Launois - 1997 - Publication in the CES0079 - L. Baret-Cormel - 05 dec 2002 - |
Active substance: ACETYL SALICYLIC ACID |
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Document reference: 46181 |
Study title: Evaluation of ibuprofen versus Aspirin and Paracetamol on efficacy and comfort in children with fever - E. Autret, J. Reboul-Marty, B. Henry-Launois, C. Laborde, S. Courcier, JM Goehrs, G. Languillat, R. Launois - 1997 - Publication - |
Active substance: ACETYL SALICYLIC ACID |
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Document reference: 46164 |
Study title: Traitement des céphalées de l'encéphalographie gazeuse fractionnée par l'aspirine injectable - M. Sethian, MJ Rosset, JC Manelli, C Raybaud, J Fabre - 1972 - Publication in the report N° FILIRF-FRZ0069-EN-E01 - |
Active substance: ACETYL SALICYLIC ACID |
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Document reference: 46177 |
Study title: Short-time-immunotherapy with Allergoids, results from prospective, open Study in allergergological practices; Allergovit patients with seasonal rhino conjunctivitis and/or asthma symptoms Age of patients: 4 – 75 Years, 2047 Patients Allergologie, Jahrgang 28, Nr. 10/2005, S. 391-400 |
Active substance: 006 Grasses (178 Kentucky Blue Grass, 179 Meadow Fescue, 140 Orchard Grass, 157 Rye Grass, 177 Timothy Grass, 133 Velvet Grass) |
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Document reference: 39754 |
Study title: Bladder pheochromocytoma: case presentation and the use of OctreoScan for localization of extra-adrenal tumour sites in a paediatric patientP R Health Sci J. 2008 Mar; 27(1):107-11 |
Active substance: (111In) INDIUM CHLORIDE/PENTETREOTIDE |
Study summary document link (including results): 2011-09 GE Indium Chloride response List of published articles.doc |
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Document reference: 48291 |
Study title: Clinical use of somatostatin analogues in paediatric oncologyAlbers AR, O'Dorisio MS; . Digestion. 1996;57 Suppl 1:38-41. |
Active substance: (111In) INDIUM CHLORIDE/PENTETREOTIDE |
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Document reference: 21233 |