- Trials with a EudraCT protocol (681)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (533)

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: Clinical Study to Investigate the Efficacy and Tolerability of Acarbose (BAY g 5421) Versus Placebo in Diabetic Children (PH 23433) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0634_study_synopsis.pdf |
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Document reference: 46155 |
Study title: Salicylémie chez le nourisson hyperthermique (évolution des taux plasmatiques après absorption de salicylés) - D. Rigal, E. Hartemann, P. Baltassat-1982 |
Active substance: ACETYL SALICYLIC ACID |
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Document reference: 46176 |
Study title: Ballmer−Weber−B−K, Gex−Collet−C, Wüthrich−B. Inhibition of histamine or allergen−induced wheals by a single dose of acrivastine, fexofenadine or cetirizine. Journal of investigational allergology & clinical immunology : official organ of the International Association of Asthmology (INTERASMA) and Sociedad Latinoamericana de Alergia e Inmunología, Nov−Dec 1999, vol. 9, no. 6, p. 351−5.Ballmer−Weber−B−K, Gex−Collet−C, Wüthrich−B. Inhibition of histamine or allergen−induced wheals by a single dose of acrivastine, fexofenadine or cetirizine. Journal of investigational allergology & clinical immunology : official organ of the International Association of Asthmology (INTERASMA) and Sociedad Latinoamericana de Alergia e Inmunología, Nov−Dec 1999, vol. 9, no. 6, p. 351−5. |
Active substance: ACRIVASTIN |
Study summary document link (including results): |
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Document reference: 46229 |
Study title: A MULTI-CENTER, INVESTIGATOR-MASKED, RANDOMIZED, ACTIVE CONTROLLED, PARALELL GROUP SUPERIORITY STUDY TO COMPARE THE CLINICAL EFFICACY OF ADAPALENE GEL, 0.3% VERSUS ADAPALENE GEL, 0.1%, IN THE TREATMENT OF ACNE VULGARIS - PHASE III |
Active substance: ADAPALENE |
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Document reference: 46279 |
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 |
Study summary document link (including results): |
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Document reference: 46290 |
Study title: A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ZENTEL IN THE TREATMENT OF INTESTINAL HELMINTHIASIS IN KENYAN CHILDREN LESS THAN 2 YEARS OF AGE |
Active substance: ALBENDAZOLE |
Study summary document link (including results): Study AL-MEA-0172-Albendazole.xls |
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Document reference: 46322 |
Study title: An open label study to investigate the pharmacokinetic profile of alendronate in paediatric patients with osteogenesis imperfecta. |
Active substance: ALENDRONIC ACID |
Study summary document link (including results): |
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Document reference: 46328 |
Study title: An Open-Labeled Study to Investigate the Pharmacokinetic Profile of Alendronate in Glucocorticoid-Treated Pediatric Patients |
Active substance: ALENDRONIC ACID |
Study summary document link (including results): |
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Document reference: 46326 |
Study title: International clinical study to investigate the incidence of inhibitors in previously untreated patients with severe haemophilia A treated with Octate (=Wilate). |
Active substance: ALGINIC ACID COMBINATIONS |
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Document reference: 46426 |
Study title: The use of silicones as an approach to the management of infantile colic. Dugger J.A., Inchaustegui S.R., J. Michigan State Medical Soc. 62, 46-49, 1963. The use of silicones as an approach to the management of infantile colic. Dugger J.A., Inchaustegui S.R., J. Michigan State Medical Soc. 62, 46-49, 1963. |
Active substance: ALGELDRATE + MAGNESIUM HYDROXIDE + SIMETICONE/ ALDEGRATE+ MAGNESIUM HYDROXIDE |
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Document reference: 46393 |
Study title: Pharmacoclinical investigation of the DA hypothesis in child autism with Amisulpride and Bromocriptine - Dollfus S. - 15/11/1989 |
Active substance: AMISULPRIDE |
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Document reference: 21683 |
Study title: "Effect of prophylactic amiodarone on mortality after acute myocardial infarction and in congestive heart failure: meat-analysis of individual data from 6500 patients in randomised trials. - ATMA investigators. - 1997 (Lancet, 350: 1417-1424) ; - Publicati" "Effect of prophylactic amiodarone on mortality after acute myocardial infarction and in congestive heart failure: meat-analysis of individual data from 6500 patients in randomised trials. - ATMA investigators. - 1997 (Lancet, 350: 1417-1424) ; - Publicati" |
Active substance: AMIODARONE |
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Document reference: 45201 |
Study title: An Open-Label Study to Investigate the Pharmacokinetics of Losartan in Hypertensive Children and Infants |
Active substance: AMPICILLIN AND SULBACTAM |
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Document reference: 21776 |
Study title: Pharmacoclinical investigation of the DA hypothesis in child autism with Amisulpride and Bromocriptine - Dollfus S. - 15/11/1989 |
Active substance: AMISULPRIDE |
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Document reference: 21685 |
Study title: "Clinical efficacy and safety of intravenous amiodarone in infants and children. - Figa FH et al. - 1994 (Am. J. Cardiol., 74: 573-577) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Clinical efficacy and safety of intravenous amiodarone in infants and children. - Figa FH et al. - 1994 (Am. J. Cardiol., 74: 573-577) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" |
Active substance: AMIODARONE |
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Document reference: 45194 |
Study title: A multi-investigator randomized trial comparing the efficacy of BMY28100 versus amoxicillin/clavulanate potassium in the treatment of acute otitis media in children. |
Active substance: AMOXICILLIN |
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Document reference: 46587 |
Study title: A randomized, investigator blinded, multicenter, comparative study of cefprozil versus high dose amoxicillin/clavulanate in the treatment of otitis media in children. |
Active substance: AMOXICILLIN |
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Document reference: 46589 |
Study title: A randomized, investigator blinded, multicenter, comparative study of Gatifloxacin versus amoxicillin/clavulanate in the treatment of recurrent otitis media and acute otitis media treatment failures in children. |
Active substance: AMOXICILLIN |
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Document reference: 46591 |
Study title: A randomized, investigator blinded, multicenter, comparative study of Gatifloxacin versus high dose amoxicillin/clavulanate in the treatment of recurrent otitis media and acute otitis media treatment failures in children. |
Active substance: AMOXICILLIN |
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Document reference: 46590 |
Study title: A Randomized , Investigator-Blind, Multicenter Study to Asses the efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 days Versus Oral Zithromax Once daily for 5 days in the treatment of Acute Otitis Media in Infants and Children |
Active substance: AMOXICILLIN AND CLAVUNALIC ACID |
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Document reference: 46631 |