- Trials with a EudraCT protocol (37)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)

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: 251: Esposito S, Marchisio P, Bosis S, Droghetti R, Mattina R, Principi N; Short Therapy Study Group. Comparative efficacy and safety of 5-day cefaclor and 10-day amoxycillin treatment of group A streptococcal pharyngitis in children. Int J Antimicrob Agents. 2002 Jul;20(1):28-33. |
Active substance: AMOXICILLIN |
Study summary document link (including results): |
View full study record |
Document reference: 46611 |
Study title: 319: Aguilar A, Tinoco JC, Macias M, Huicho L, Levy J, Trujillo H, Lopez P, Pereira M, Maqbool S, Bhutta ZA, Sacy RA, Deacon S. Clinical and bacteriologic efficacy of amoxycillin b.d. (45 mg/kg/day) versus amoxycillin t.d.s (40 mg/kg/day) in children with group A beta-hemolytic streptococcal tonsillopharyngitis. J Chemother. 2000 Oct;12(5):396-405. |
Active substance: AMOXICILLIN |
Study summary document link (including results): |
View full study record |
Document reference: 46615 |
Study title: 405: Feder HM Jr, Gerber MA, Randolph MF, Stelmach PS, Kaplan EL. Once-daily therapy for streptococcal pharyngitis with amoxicillin. Pediatrics. 1999 Jan;103(1):47-51. |
Active substance: AMOXICILLIN |
Study summary document link (including results): |
View full study record |
Document reference: 46617 |
Study title: 441: Gopichand I, Williams GD, Medendorp SV, Saracusa C, Sabella C, Lampe JB, Garcia RE, Lebrun L, Goldfarb J. Randomized, single-blinded comparative study of the efficacy of amoxicillin (40 mg/kg/day) versus standard-dose penicillin V in the treatment of group A streptococcal pharyngitis in children. Clin Pediatr (Phila). 1998 Jun;37(6):341-6. |
Active substance: AMOXICILLIN |
Study summary document link (including results): |
View full study record |
Document reference: 46620 |
Study title: A Controlled Study on the Effect of a Soluble Insert on Keratoconjunctivitis Sicca |
Active substance: ARTIFICIAL TEARS |
Study summary document link (including results): |
View full study record |
Document reference: 21867 |
Study title: Long Term Study of the Effect of a Sustained Release Artificial Tear Substitute (SR-AT) on Keratoconjunctivitis Sicca; |
Active substance: ARTIFICIAL TEARS |
Study summary document link (including results): |
View full study record |
Document reference: 21868 |
Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in childrenClinical efficacy and tolerance of bacampicillin and amoxycillin suspensions in children with acute otitis media; J Int Med Res. 1989 Jan-Feb;17(1):41-7. |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): |
View full study record |
Document reference: 22276 |
Study title: Randomized, multicenter pilot study comparing the efficacy of potassium-phenoxymethylpenicillin granules for oral suspension 100.000 IU /kg/day tid for 10 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 7 days versus benzathine-phenoxymethylpenicillin suspension 100.000 IU /kg/day bid for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyngitis in childrenEffect on urogenital flora of antibiotic therapy for urinary tract infection; Scand J Infect Dis. 1990;22(1):43-7. |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): |
View full study record |
Document reference: 22275 |
Study title: Randomized, multicenter open study comparing the efficacy of potassium-phenoxymethylpenicillin V three times daily for 10 days versus benzathine penicillin V twice daily for 5 days in the treatment of acute group A ß-hemolytic streptococcal tonsillopharyn |
Active substance: BENZATHINE PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): DV 2-99_Final Report_010531.pdf |
View full study record |
Document reference: 41960 |
Study title: Zaffanello-Marco, Zamboni-Giorgio, Fontana-Elena, Zoccante-Leonardo, Tato-Luciano. Regional Center for Neonatal Congenital Errors of Metabolism, Department of Pediatrics, University of Verona, Verona, Italy. A case of partial biotinidase deficiency associated with autism. Child neuropsychology : a journal on normal and abnormal development in childhood and adolescence, {Child-Neuropsychol}, Sep 2003, vol. 9, no. 3, p. 184-8, ISSN: 0929-7049.Zaffanello-Marco, Zamboni-Giorgio, Fontana-Elena, Zoccante-Leonardo, Tato-Luciano. Regional Center for Neonatal Congenital Errors of Metabolism, Department of Pediatrics, University of Verona, Verona, Italy. A case of partial biotinidase deficiency associated with autism. Child neuropsychology : a journal on normal and abnormal development in childho... |
Active substance: BIOTIN |
Study summary document link (including results): |
View full study record |
Document reference: 22604 |
Study title: Evaluation of the efficacy and tolerance of RU51807 (cefpodoxime proxetil 8mg/kg/day) in children with group a beta haemolytic streptococcal tonsillitis/pharyngitis. A multicenter, international, randomized, open- label, comparative study vs penicillin V 75 000 IU/kg/day |
Active substance: CEFPODOXIME |
Study summary document link (including results): CEFPODOXIME STUDY FF8980737.xls |
View full study record |
Document reference: 47972 |
Study title: Open label, non-comparative study of Cefotaxime (300 mg/kg/day) plus vancomycin (60 mg/kg/day) combination as first line treatment of pneumococcal meningitis in children aged from 3 months to 18 years |
Active substance: CEFOTAXIME |
Study summary document link (including results): Cefotaxime-Study 1.pdf |
View full study record |
Document reference: 47343 |
Study title: A comparison cure and recurrence rates among patients with streptococcal tonsillopharyngitis treated with either cefprozil (500 mg QD) vs Cefaclor (250 mg TID) in the treatment of mild to moderate strep pharyngitis and tonsillitis. |
Active substance: CEFPROZIL |
Study summary document link (including results): |
View full study record |
Document reference: 23581 |
Study title: A multi-center, comparative study of cefprozil and penicillin V in the treatment of mild to moderate streptococcal tonsillopharyngitis (final report on study AI414-084 - pediatric). |
Active substance: CEFPROZIL |
Study summary document link (including results): Protocol ai414-084 Cefprozil.pdf |
View full study record |
Document reference: 23575 |
Study title: Cefpodoxime Proxetil - Mark A. Del Beccaro, MD - 1993 (Pediatric annals 22:3)Cefpodoxime Proxetil - Mark A. Del Beccaro, MD - 1993 (Pediatric annals 22:3) |
Active substance: CEFPODOXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23557 |
Study title: Cefpodoxime Proxetil versus penicillin V in the treatment of streptococcal pharyngitis in children - Nancy E. Kline, Mark W. Kline - 1991 (Current Therapeutic Research, Vol. 49, N° 5 )Cefpodoxime Proxetil versus penicillin V in the treatment of streptococcal pharyngitis in children - Nancy E. Kline, Mark W. Kline - 1991 (Current Therapeutic Research, Vol. 49, N° 5 ) |
Active substance: CEFPODOXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23560 |
Study title: Cefpodoxime Proxetil vs penicillin V in pediatric streptococcal pharyngitis / tonsillitis - Adnan S. Dajani, MD, Susan L. Kessler, MD, Robert Mendelson, MD, Donald L. Udan, PharmD, Wesley Mark Todd, MD - 1993 (Pediatr Infect Dis J; 12: 275 - 279)Cefpodoxime Proxetil vs penicillin V in pediatric streptococcal pharyngitis / tonsillitis - Adnan S. Dajani, MD, Susan L. Kessler, MD, Robert Mendelson, MD, Donald L. Udan, PharmD, Wesley Mark Todd, MD - 1993 (Pediatr Infect Dis J; 12: 275 - 279) |
Active substance: CEFPODOXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23561 |
Study title: Cephalosporins are superior to penicillin for treatment of streptococcal tonsillopharyngitis: is the difference worth it? - Michael E. Pichichero, MD - 1993 (Pediatr Infec Dis J, 12: 268-74)Cephalosporins are superior to penicillin for treatment of streptococcal tonsillopharyngitis: is the difference worth it? - Michael E. Pichichero, MD - 1993 (Pediatr Infec Dis J, 12: 268-74) |
Active substance: CEFPODOXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23563 |
Study title: Boccazzi A, Tonelli P, Bellosta C, Careddu P. Clinical and pharmacological evaluation of a modified cefotaxime bid regimen versus traditional tid in pediatric lower respiratory tract infections. Diagn Microbiol Infect Dis. 1998 Dec;32(4):265-72.Boccazzi A, Tonelli P, Bellosta C, Careddu P. Clinical and pharmacological evaluation of a modified cefotaxime bid regimen versus traditional tid in pediatric lower respiratory tract infections. Diagn Microbiol Infect Dis. 1998 Dec;32(4):265-72. |
Active substance: CEFOTAXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23464 |
Study title: Comparison of cefpodoxime proxetil oral suspension (100 mg / 5 ml) (DoxefTM; U-76252; CS-807) and penicillin V potassium oral suspension in the treatment of acute streptococcal pharyngitis / tonsillitis in infants and children - M-1140-0028 - LM. Paxton |
Active substance: CEFPODOXIME |
Study summary document link (including results): CEFPODOXIME STUDY TR915590018.xls |
View full study record |
Document reference: 23523 |