- Trials with a EudraCT protocol (28)
- 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: 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: 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 expert report on the clinical documentation - P. Grippon - 12 Nov 1991 - |
Active substance: ACETYL SALICYLIC ACID |
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Document reference: 46179 |
Study title: Anwendungsbeobachtung zu Wirksamkeit und Verträglichkeit von Imupret Tropfen oder Dragees zur Behandlung von rezidivierenden Atemwegserkrankungen bei Kindern und Jugendlichen |
Active substance: alcoholic-aqueous extract (extracting agent: ethanol 59 vol. %) derived from marshmallow root chamomile flowers horstail herb walnut leaves yarrow herb oak bark dandelion herb |
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Document reference: 39777 |
Study title: Anwendungsbeobachtung zu Wirksamkeit und Verträglichkeit von Imupret Tropfen oder Dragees zur Behandlung von rezidivierenden Atemwegserkrankungen bei Kindern und Jugendlichen |
Active substance: aqueous extract (extracting agent: ethanol 59 % ), 0.4 g marshmallow root (Althaeae radix), 0.4 g walnut leaves (Juglandis folia), 0.3 g chamomile flowers (Chamomillae flores), 0.5 g horsetail herb (Equiseti herba), 0.4 g common yarrow (Achillea millefolium), 0.2 g oak bark (Quercus cortex), 0.4 g dandelion herb (Taraxaci herba). |
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Document reference: 39795 |
Study title: Burlina-A-B, Dermikol-M, Mantau-A, Piovan-S, Grazian-L, Zacchello-F, Shin-Y. Department of Pediatrics, University of Padova, Italy. Increased plasma biotinidase activity in patients with glycogen storage disease type Ia: effect of biotin supplementation. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 1996, vol. 19, no. 2, p. 209-12, ISSN: 0141-8955.Burlina-A-B, Dermikol-M, Mantau-A, Piovan-S, Grazian-L, Zacchello-F, Shin-Y. Department of Pediatrics, University of Padova, Italy. Increased plasma biotinidase activity in patients with glycogen storage disease type Ia: effect of biotin supplementation. Journal of inherited metabolic disease, {J-Inherit-Metab-Dis}, 1996, vol. 19, no. 2, p. 209-12, ISSN: 0141-8955. |
Active substance: BIOTIN |
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Document reference: 22618 |
Study title: Nothjunge-J, Krageloh-Mann-I, Suormala-T-M, Baumgartner-E-R. Abteilung Allgemeine Padiatrie, Universitats-Kinderklinik, Tubingen, Germany. Biotinidase deficiency: A hereditary metabolic disorder successfully treated with biotin. Monatsschrift fur Kinderheilkunde {MONATSSCHR-KINDERHEILKD}, 1989, Vol/Iss/Pg. 137/11 (737-740), ISSN: 0026-9298.Nothjunge-J, Krageloh-Mann-I, Suormala-T-M, Baumgartner-E-R. Abteilung Allgemeine Padiatrie, Universitats-Kinderklinik, Tubingen, Germany. Biotinidase deficiency: A hereditary metabolic disorder successfully treated with biotin. Monatsschrift fur Kinderheilkunde {MONATSSCHR-KINDERHEILKD}, 1989, Vol/Iss/Pg. 137/11 (737-740), ISSN: 0026-9298. |
Active substance: BIOTIN |
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Document reference: 22634 |
Study title: Usefulness of Bisacodyl dragees for preparation of patients for radiographic procedures |
Active substance: BISACODYL |
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Document reference: 22711 |
Study title: Ozen H, Ciliv G, Koçak N, Saltik IN, Yüce A, Gürakan F. Short-term effect of captopril on microalbuminuria in children with glycogen storage disease type Ia. J Inherit Metab Dis. 2000 Jul;23(5):459-63. PMID: 10947200 [PubMed - indexed for MEDLINE]Ozen H, Ciliv G, Koçak N, Saltik IN, Yüce A, Gürakan F. Short-term effect of captopril on microalbuminuria in children with glycogen storage disease type Ia. J Inherit Metab Dis. 2000 Jul;23(5):459-63. PMID: 10947200 [PubMed - indexed for MEDLINE] |
Active substance: CAPTOPRIL |
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Document reference: 23229 |
Study title: Examination of the cariogenic effect of repeated intake of sucrose-containing beverage and prevention by fluoride containing varnishes |
Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
Study summary document link (including results): Report-Bifluorid 12_Plaque screening_QLF inspector_english.pdf |
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Document reference: 23182 |
Study title: A Multicenter, Randomized, Controlled Trial of Celsior for Flush and Hypothermic Storage of Cardiac AllograftsVega 2001 |
Active substance: CELSIOR |
Study summary document link (including results): Vega 2001.pdf |
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Document reference: 48355 |
Study title: Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 25051 |
Study title: Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 25052 |
Study title: DIECKMANN-K, MAURAGE-C, ROLLAND-J-C, RAMPONI-N, JONVILLE-A-P, ET-AL. CHU CLOCHEVILLE, TOURS, FRANCE. TORTICOLLIS AS A SIDE EFFECT OF CISAPRIDE TREATMENT IN AN INFANT. JOURNAL-OF-PEDIATRIC-GASTROENTEROLOGY-AND-NUTRITION (J-PEDIATR- GASTROENTEROL-NUTR). 22: 336-337, APR 1996.DIECKMANN-K, MAURAGE-C, ROLLAND-J-C, RAMPONI-N, JONVILLE-A-P, ET-AL. CHU CLOCHEVILLE, TOURS, FRANCE. TORTICOLLIS AS A SIDE EFFECT OF CISAPRIDE TREATMENT IN AN INFANT. JOURNAL-OF-PEDIATRIC-GASTROENTEROLOGY-AND-NUTRITION (J-PEDIATR- GASTROENTEROL-NUTR). 22: 336-337, APR 1996. |
Active substance: TRIMEBUTINE |
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Document reference: 46755 |
Study title: CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC ACTIVITY AND TOLERABILITY OF ANAFRANIL 10MG DRAGEES IN CHILDREN SUFFERING FROM DEPRESSION, ANOREXIA, ENURESIS, SCHOOL-PHOBIA, PHOBIA AND OBSESSION OR ANXIETY |
Active substance: CLOMIPRAMINE |
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Document reference: 24388 |
Study title: Coverage and cost of iodized oil capsule distribution in Tanzania. ;Peterson-S. Health Policy and Planning, 1999, Vol/Iss/Pg. 14 /4 (390-399)Coverage and cost of iodized oil capsule distribution in Tanzania. ;Peterson-S. Health Policy and Planning, 1999, Vol/Iss/Pg. 14 /4 (390-399) |
Active substance: IODINE |
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Document reference: 30226 |
Study title: Am J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi RAm J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi R |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44508 |
Study title: Wirksamkeit und Vertraeglichkeit von Rytmonorm 10 mg, Dragees, bei Kindern - Ergebnisse einer multizentrischen Studie - (Efficacy and safety of Rytmonorm 10 mg sugar-coated tablets in children - Results of a multicentre study -) |
Active substance: PROPAFENONE |
Study summary document link (including results): propafenone-m03681.pdf |
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Document reference: 35059 |
Study title: THE NECESSITY FOR GRAM NEGATIVE ANTIMICROBIAL COVERAGE IN THE PREVENTION OF INFECTION FOLLOWING HEAD AND NECK SURGERY |
Active substance: SULBACTAM |
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Document reference: 42628 |
Study title: Clin Nucl Med. 1988 Apr;13(4):286-90. Experience with thallium-201 imaging in head and neck cancer. el-Gazzar AH, Sahweil A, Abdel-Dayem HM, Kubasik H, Halker R, Hassan IM, Jamil M, Rageb A, Abdul-Rahim SM, Mahmoud A, et al. Clin Nucl Med. 1988 Apr;13(4):286-90. Experience with thallium-201 imaging in head and neck cancer. el-Gazzar AH, Sahweil A, Abdel-Dayem HM, Kubasik H, Halker R, Hassan IM, Jamil M, Rageb A, Abdul-Rahim SM, Mahmoud A, et al. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44541 |
Study title: Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8 |
Active substance: MITOXANTRONE |
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Document reference: 32232 |