- Trials with a EudraCT protocol (992)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (38)

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: Sweetman-L, Surh-L, Baker-H, Peterson-R-M, Nyhan-W-L. Clinical and metabolic abnormalities in a boy with dietary deficiency of biotin. Pediatrics, {Pediatrics}, Oct 1981, vol. 68, no. 4, p. 553-8, ISSN: 0031-4005.Sweetman-L, Surh-L, Baker-H, Peterson-R-M, Nyhan-W-L. Clinical and metabolic abnormalities in a boy with dietary deficiency of biotin. Pediatrics, {Pediatrics}, Oct 1981, vol. 68, no. 4, p. 553-8, ISSN: 0031-4005. |
Active substance: BIOTIN |
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Document reference: 22579 |
Study title: Dibba B, Prentice A, Ceesay M, Stirling DM, Cole TJ, Poskitt EM. Effect of calcium supplementation on bone mineral accretion in Gambian children accustomed to a low-calcium diet. Am J Clin Nutr. 2000 Feb; 71(2):544-9. Dibba B, Prentice A, Ceesay M, Stirling DM, Cole TJ, Poskitt EM. Effect of calcium supplementation on bone mineral accretion in Gambian children accustomed to a low-calcium diet. Am J Clin Nutr. 2000 Feb; 71(2):544-9. |
Active substance: CALCIUM CARBONATE |
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Document reference: 23158 |
Study title: National Academy of Sciences, Institute of Medicine Dietary Reference Intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. National Academy Press: Washington, DC, 1997 |
Active substance: CALCIUM COMBINATIONS |
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Document reference: 23174 |
Study title: (Course of dysentery and the specific alteration of the neutrophils in children in the use of monomycin and a diet with an increased protein content). Techenie dizenterii i spetsificheskaia al'teratsiia neitrofilov krovi u detei v usloviiakh primeneniia monomitsina i diety s povyshennym soderzhaniem belka.Vereshchagin I A, Chernichenko A M. Antibiotiki. 1979 Jul;24(7):532-5. Russian |
Active substance: ERYTHROMYCIN |
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Document reference: 26543 |
Study title: |
Active substance: Diclofenac diethylamine |
Study summary document link (including results): 2011-EMA spreadsheet - Voltaren Emulgel - TOPM1.xls |
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Document reference: 47910 |
Study title: |
Active substance: Diclofenac diethylamine |
Study summary document link (including results): 2011-EMA spreadsheet - Voltaren Emulgel - NGB8855.xls |
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Document reference: 47911 |
Study title: |
Active substance: Diclofenac diethylamine |
Study summary document link (including results): 2011-EMA spreadsheet - Voltaren Emulgel - NF113.xls |
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Document reference: 47912 |
Study title: |
Active substance: Diclofenac diethylamine |
Study summary document link (including results): 2011-EMA spreadsheet - Voltaren Emulgel - TOPO1.xls |
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Document reference: 47914 |
Study title: Study back-ground: Demonstration of efficacy of topically applied Voltaren Emulgel in patients with soft tissue rheumatism |
Active substance: Diclofenac diethylamine |
Study summary document link (including results): 2011-EMA spreadsheet - Voltaren Emulgel - NF112.xls |
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Document reference: 47913 |
Study title: Tay CL, Tan S. Diclofenac or paracetamol for analgesia in paediatric myringotomy outpatients. Anaesth Intensive Care. 2002 Feb;30(1):55-9.Tay CL, Tan S. Diclofenac or paracetamol for analgesia in paediatric myringotomy outpatients. Anaesth Intensive Care. 2002 Feb;30(1):55-9. |
Active substance: Diclofenac diethylamine |
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Document reference: 25966 |
Study title: Recommended dietary intakes (RDI) of vitamin C in humans |
Active substance: CHLORPHENAMINE AND FERROUS AND PARACETAMOL |
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Document reference: 24031 |
Study title: Double-Blind Comparative Studies of Ivermectin, Diethylcarbamazine Citrate and Placebo in Patients with Onchocerciasis. |
Active substance: IVERMECTIN |
Study summary document link (including results): Stromectol_Ivermectin_514_Synopsis.pdf |
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Document reference: 30823 |
Study title: Nucl Med Commun. 1999 Mar;20(3):255-61. Positron emission tomography using 18F-fluorodeoxyglucose in advanced stages of malignant melanoma: a comparison of ultrasonographic and radiological methods of diagnosis. Dietlein M, Krug B, Groth W, Smolarz K, Scheidhauer K, Psaras T, Stützer H, Lackner K, Schicha H. |
Active substance: FLUDEOXYGLUCOSE |
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Document reference: 28185 |
Study title: Rofo. 1999 Aug;171(2):87-94. [The lymph node staging of malignant testicular germ-cell tumors] [Article in German] Krug B, Heidenreich A, Dietlein M, Lackner K. |
Active substance: FLUDEOXYGLUCOSE |
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Document reference: 28183 |
Study title: Open clinical study in MRI (Magnetic Resonance Imaging) to demonstrate the tolerance and efficacy of Gd-DTPA (Gadolinium Diethylene triamine penta acetic Acid) in the whole body |
Active substance: GADOPENTETIC ACID |
Study summary document link (including results): Bayer Pharma_Gadopentetate Dimeglumine_87054_study_synopsis.pdf |
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Document reference: 28821 |
Study title: .Hampl JS, Betts NM, Benes BA. The "age+5" rule: comparasion of dietery fiber intake among 4- to 10-year-old children. J Am Diet Assoc. 1998 Dec; 98(12):1418-23. |
Active substance: Ispaghula seed |
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Document reference: 40033 |
Study title: Leis R, Pavon P, Queiro T, Recarey D, Tojo R. Atherogenic diet and blood lipidprofile in children and adolescents from Galicia, NW Spain. The Galinut Study. Acta Paediatr. 1999 Jan; 88(1):19-23. |
Active substance: Ispaghula seed |
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Document reference: 21224 |
Study title: Leis R, Pavon P, Queiro T, Recarey D, Tojo R. Atherogenic diet and blood lipidprofile in children and adolescents from Galicia, NW Spain. The Galinut Study. Acta Paediatr. 1999 Jan; 88(1):19-23. |
Active substance: Ispaghula seed |
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Document reference: 40034 |
Study title: Saldanha LG. Fiber in the diet of US children: results of national surveys. Paediatrics. 1995 Nov; 96 (5 Pt 2): 994-7. |
Active substance: Ispaghula seed |
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Document reference: 40035 |
Study title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Cholesterol-Lowering Efficacy and Safety of Simvastatin as an Adjunct to Diet in Children and Adolescents With Familial Hypercholesterolemia |
Active substance: SIMVASTATIN |
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Document reference: 42224 |