- Trials with a EudraCT protocol (143)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (25)

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: Nisylen Tabletten Beobachtungsstudie |
Active substance: Aconitum Trit. D3 25 mg Gelsemium Trit. D3 25 mg Phosphorus Trit. D5 25 mg Bryonia Trit. D2 25 mg Eupatorium perfoliatum Trit. D1 25 mg |
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Document reference: 39737 |
Study title: A MULTICENTER, RANDOMIZED, INVESTIGATOR-BLINDED, PARALLEL GROUP COMPARISON OF ADAPALENE GEL (CD271G) 0.1% AND ITS VEHICLE IN THE TREATMENT OF ACNE VULGARIS - PHASE III |
Active substance: ADAPALENE |
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Document reference: 46290 |
Study title: Acute toxicity of KWD2183 in young rats after single oral administration |
Active substance: BAMBUTEROL HYDROCHLORIDE |
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Document reference: 22123 |
Study title: General toxicity of KWD2183 given orally to young rats for three months |
Active substance: BAMBUTEROL HYDROCHLORIDE |
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Document reference: 22124 |
Study title: General toxicity of bambuterol (KWD2183) given orally to young rats for three months. Plasma concentration study. (Appendix 4:2 to report T2030) |
Active substance: BAMBUTEROL HYDROCHLORIDE |
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Document reference: 22125 |
Study title: Multinationale und multizentrische Anwendungsbeobachtung mit Tonsiotren® H gemäß §67, 6 AMG bei Patienten mit akuter Angina bzw. akuter Exazerbation einer chronischen rezidivierenden Angina |
Active substance: Atropinum sulfuricum Trit. D5 12,5 mg Hepar sulfuris Trit. D3 (nach Vorschrift 6 HAB) 10,0 mg Kalium bichromicum Trit. D4 50,0 mg Silicea Trit. D2 5,0 mg Mercurius bijodatus Trit. D8 25,0 mg |
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Document reference: 39740 |
Study title: Pharmacokinetic of a 80000 UI Vitamine D2 ampoule in eutrophic newborns |
Active substance: ERGOCALCIFEROL |
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Document reference: 26408 |
Study title: Cetirizin effects on children with atopic dermatitis. correlation among the eosinophil cationic protein (ecp), il2r soluble (cd25), cd23 (b cells) and clinical score. |
Active substance: CETIRIZINE |
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Document reference: 23689 |
Study title: A multi-centre, randomised, double-blind, parallel group study to validate the changes in tidal breathing lung function parameters versus FEV1 and PD20 assessments due to anti-inflammatory treatment in 5 to 10 years old mild to moderately symptomatic children with asthma. Extensive searching has revealed that no clinical report is available for this study. The clinical trial results were reported via publications; see citation below. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FMS30002-ICHE3.pdf |
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Document reference: 28397 |
Study title: Observational study Hypotonie-Gastreu R44 |
Active substance: (HMP) Crataegus D1, Laurocerasus D3, Oleander D3, Spartium scoparium D2 |
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Document reference: 39734 |
Study title: Efficacy of Tonsilotren in the treatment of acute angina catarrhalis. |
Active substance: (Homeopathic) Per tablet: Atropinum sulfuricum D5 12,5 mg Hepar sulfuris D3 10,0 mg Kalium bichromicum D4 50,0 mg Silicea D2 5,0 mg Mercurius bijodatus D8 25,0 mg |
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Document reference: 39745 |
Study title: Modulation of the immediate allergic wheal reaction in the skin by drugs inhibiting the effects of leukotriene C4 and prostaglandin D2. |
Active substance: INDOMETHACIN |
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Document reference: 29970 |
Study title: Application of Intravenous Contrast in PET/CT:Does It Really Introduce Significant Attenuation Correction Error?J Nucl Med 2005; 46:283–291. Yat-Yin Yau, MD1; Wing-Sze Chan, BSc1; Yat-Man Tam, MSc1; Phil Vernon, PhD2; So Wong1; Marc Coel, MD3; and Simon Kwok-Fai Chu1 |
Active substance: Steripet |
Study summary document link (including results): yau-2005.pdf |
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Document reference: 48747 |
Study title: NHS dental epidemology programme for England2010-Rooney |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 2010-Rooney-NHS dental epidemology programme for England.pdf |
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Document reference: 49092 |
Study title: Clinical Performance of PET/CT in Evaluation of Cancer: Additional Value for Diagnostic Imaging and Patient ManagementRachel Bar-Shalom, MD1; Nikolai Yefremov, MD1; Ludmila Guralnik, MD2; Diana Gaitini, MD2,3; Alex Frenkel, DSc1; Abraham Kuten, MD3,4; Hernan Altman, MBA5; Zohar Keidar, MD, PhD1; and Ora Israel, MD1,3. THE JOURNAL OF NUCLEAR MEDICINE • Vol. 44 • No. 8 • August 2003 |
Active substance: Steripet |
Study summary document link (including results): bar-shalom-2003.pdf |
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Document reference: 48623 |
Study title: Comparison of 18F-FDG and 11C-Methionine for PET-Guided Stereotactic Brain Biopsy of GliomasJ Nucl Med 2004; 45:1293–1298. Benoit Pirotte, MD1; Serge Goldman, MD, PhD2; Nicolas Massager, MD1; Philippe David, MD3; David Wikler, MS1; Arlette Vandesteene, MD, PhD4; Isabelle Salmon, MD, PhD5; Jacques Brotchi, MD, PhD1; and Marc Levivier, MD, PhD1 |
Active substance: Steripet |
Study summary document link (including results): pirotte-2004.pdf |
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Document reference: 48742 |
Study title: Effects on the respiratory tract and male reproductive organs in young rats given formoterol fumarate (D2522) in lactose by the inhalation route for 3 months |
Active substance: FORMOTEROL |
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Document reference: 47838 |
Study title: Single dose toxicity of formoterol fumarate (D2522) in young rats after oral administration. |
Active substance: FORMOTEROL |
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Document reference: 47863 |
Study title: Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal”) |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30018-ICHE3.pdf |
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Document reference: 28451 |
Study title: Testicular effects of formoterol fumarate (D2522) given orally to young rats for three months, using salbutamol sulphate as a reference compound |
Active substance: FORMOTEROL |
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Document reference: 47867 |