- Trials with a EudraCT protocol (27)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (264)
Query did not match any clinical trials.
| 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: A double-blind, multicenter, multi-dose, parallel group, placebo-controlled study on the efficacy and safety of a homeopathic combination remedy vs.placebo over 14 days of treatment in children with acute otitis media. |
| Active substance: Aconitum napellus Dil. D6 0,075 ml; Capsicum annuum Dil. D4 0,075 ml; Chamomilla recutita Ø 0,225 ml; Echinacea purpurea Ø 0,75 ml; Hydrargyrum bicyanatum Dil. D6 0,075 ml; Hydrastis canadensis Dil. D4 0,075 ml; Iodum Dil. D4 0,075 ml; Natrium tetraboracicum Dil. D4 0,075 ml; Sambucus nigra Ø 0,225 ml; Sanguinaria canadensis Ø 0,075 ml. |
| Study summary document link (including results): |
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| Document reference: 39772 |
| 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: US: A MULTI-CENTER RANDOMIZED DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ADAPALENE 0.1% AND BENZOYL PEROXIDE 2.5% (ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL) GEL COMPARED TO EACH MONAD AND TOPICAL GEL VEHICLE IN SUBJECTS WITH ACNE VULGARIS - PHASE II / III THERAPEUTIC CONFIRMATORY |
| Active substance: ADAPALENE |
| Study summary document link (including results): |
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| Document reference: 46287 |
| Study title: Reduction of side-effects from ultrarush immunotherapy with honeybee venom by pretreatment with fexofenadine: a double-blind, placebo-controlled trial |
| Active substance: APIS MELIFERA-LYOPHILISED BEE VENOM |
| Study summary document link (including results): |
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| Document reference: 21825 |
| Study title: Development of Immunocytochemical Methods for Luivac Tablets Bio-Medical Consulting Group Toronto-Munich, Bowmanville, Ontario, Canada (1997) |
| Active substance: Bacterial lysate |
| Study summary document link (including results): |
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| Document reference: 41835 |
| Study title: Casado-de-Frias-E, Campos-Castello-J, Careaga-Maldonado-J, Perez-Cerda-C. Department of Pediatrics, Hospital Universitario San Carlos UCM, Madrid, Spain. Biotinidase deficiency: result of treatment with biotin from age 12 years. European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society, {Eur-J-Paediatr-Neurol}, 1997, vol. 1, no. 5-6, p. 173-6, ISSN: 1090-3798.Casado-de-Frias-E, Campos-Castello-J, Careaga-Maldonado-J, Perez-Cerda-C. Department of Pediatrics, Hospital Universitario San Carlos UCM, Madrid, Spain. Biotinidase deficiency: result of treatment with biotin from age 12 years. European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society, {Eur-J-Paediatr-Neurol}, 1997, vol. 1, ... |
| Active substance: BIOTIN |
| Study summary document link (including results): |
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| Document reference: 22614 |
| Study title: Mann JR et al, UKCCSG's germ cell tumour (GCT) studies: improving outcome for children with malignant extracranial non-gonadal tumours--carboplatin, etoposide, and bleomycin, are effective and less toxic than previous regimens. United Kingdom Children's Cancer Study Group, Med Pediatr Oncol. 1998 Apr;30(4):217-27Mann JR et al, UKCCSG's germ cell tumour (GCT) studies: improving outcome for children with malignant extracranial non-gonadal tumours--carboplatin, etoposide, and bleomycin, are effective and less toxic than previous regimens. United Kingdom Children's Cancer Study Group, Med Pediatr Oncol. 1998 Apr;30(4):217-27 |
| Active substance: BLEOMYCIN |
| Study summary document link (including results): |
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| Document reference: 22805 |
| Study title: Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin diseaseDecreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease |
| Active substance: BLEOMYCIN |
| Study summary document link (including results): |
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| Document reference: 22814 |
| Study title: Clinical assessment of Chlorchinaldin lozenges |
| Active substance: CHLORQUINADOLUM |
| Study summary document link (including results): |
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| Document reference: 47177 |
| Study title: Combined growth Hormone and Gonadotropin releasing Hormone analogue tretment in adopted girls with precocious or early puberty. Tuvemo et. Al 1998.Combined growth Hormone and Gonadotropin releasing Hormone analogue tretment in adopted girls with precocious or early puberty. Tuvemo et. Al 1998. |
| Active substance: Buserelin |
| Study summary document link (including results): |
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| Document reference: 41849 |
| Study title: Probable Benadryl withdrawal manifestations in a newborn infant, Parkin, D.E., J. Pediatr. 1974; 85: 580Probable Benadryl withdrawal manifestations in a newborn infant, Parkin, D.E., J. Pediatr. 1974; 85: 580 |
| Active substance: CAFFEINE AND DIMENHYDRINATE |
| Study summary document link (including results): |
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| Document reference: 23118 |
| Study title: Benador D. Randomised controlled trial of three day versus 10 day intravenous antibiotics in acute pyelonephritis: effect on renal scarring (J Paediatr 2001; 139 (3): 467-468); Titz B. Benador D. Randomised controlled trial of three day versus 10 day intravenous antibiotics in acute pyelonephritis: effect on renal scarring (J Paediatr 2001; 139 (3): 467-468); Titz B. |
| Active substance: CEFIXIME |
| Study summary document link (including results): |
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| Document reference: 23447 |
| Study title: Effects of fexofenadine, diphenhydramine, and placebo on performance of the test of variables of attention, Mansfield, L., Ann. Allergy Asthma Immunol. 2003 May; 90(5): 554-559Effects of fexofenadine, diphenhydramine, and placebo on performance of the test of variables of attention, Mansfield, L., Ann. Allergy Asthma Immunol. 2003 May; 90(5): 554-559 |
| Active substance: CAFFEINE AND DIMENHYDRINATE |
| Study summary document link (including results): |
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| Document reference: 23117 |
| Study title: Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with over-the counter antihistamines, ibuprofen and clemasine, Pratt, C.M., Am. J. Cardiol. 1994; 73: 346-352Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with over-the counter antihistamines, ibuprofen and clemasine, Pratt, C.M., Am. J. Cardiol. 1994; 73: 346-352 |
| Active substance: CAFFEINE AND DIMENHYDRINATE |
| Study summary document link (including results): |
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| Document reference: 23119 |
| Study title: 1 Month Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal Sprague Dawley Rat. AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Montreal Inc, Senneville, Canada). May 2006. |
| Active substance: ESOMEPRAZOLE |
| Study summary document link (including results): |
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| Document reference: 26622 |
| Study title: A 3-Month Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal Beagle Dog (a Second Complementary Study). AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Montreal Inc, Senneville, Canada). |
| Active substance: ESOMEPRAZOLE |
| Study summary document link (including results): |
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| Document reference: 26611 |
| Study title: Open, controlled, randomised, parallel and multicentre study of the tolerability and the safety of ebastine 2,5 mg once a day in comparison with terfenadine 15 mg twice a day in the sympthomatic treatment of allergic rhinitis and/or allergic conjunctivitis in patients aged from 2 to 5 years old |
| Active substance: EBASTINE |
| Study summary document link (including results): 090-103_Ebastine_EUdraCT_reduced datafields-CP-Almirall.xls |
| View full study record |
| Document reference: 48067 |
| Study title: Evaluation of the potential cardiotoxicity of the antihistamines terfenadine, astemizole, loratadine, and cetirizine in atopic children. Delgado L F, Pferferman A, Solé D, Naspitz C K. Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, Apr 1998, vol. 80, no. 4, p. 333 7. |
| Active substance: ERYTHROMYCIN |
| Study summary document link (including results): |
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| Document reference: 26452 |
| Study title: Mann JR et al, UKCCSG's germ cell tumour (GCT) studies: improving outcome for children with malignant extracranial non-gonadal tumours--carboplatin, etoposide, and bleomycin are effective and less toxic than previous regimens. United Kingdom Children's Cancer Study Group, Med Pediatr Oncol. 1998 Apr;30(4):217-27. Review |
| Active substance: ETOPOSIDE |
| Study summary document link (including results): |
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| Document reference: 26863 |
| Study title: Nadkarni V et al. Paediatric Life Support. Resuscitation (1997) 34: 115-127 |
| Active substance: EPHINEPHRINE |
| Study summary document link (including results): |
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| Document reference: 26380 |
