- Trials with a EudraCT protocol (15)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (46)

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: 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 |
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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 |
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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 |
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Document reference: 41960 |
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 b |
Active substance: BENZATHINE PHENOXYMETHYLPENICILLIN |
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Document reference: 41959 |
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 children |
Active substance: CEFALEXIN |
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Document reference: 23388 |
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 children |
Active substance: CEFALEXIN |
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Document reference: 23387 |
Study title: Effect of phenoxymethylpenicillin and erythromycin prophylaxis on anaerobic bacteraemia after oral surgery. Josefsson K, Heimdahl A, von Konow L, Nord C E. The Journal of antimicrobial chemotherapy, {J−Antimicrob−Chemother}, Aug 1985, vol. 16, no. 2, p.243−51, ISSN: 0305−7453. |
Active substance: ERYTHROMYCIN |
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Document reference: 26518 |
Study title: Erythromycin and phenoxymethylpenicillin (penicillin V) in the treatment of respiratory tract infections as related to microbiological findings and serum C−reactive protein. Söderström M, Blomberg J, Christensen P, Hovelius B. Scandinavian journal of infectious diseases, 1991, vol. 23, no. 3, p. 347−54. |
Active substance: ERYTHROMYCIN |
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Document reference: 26488 |
Study title: A single-blind trial to investigate the ethiology of bacterial respiratory tract infections and the efficacy of penicillin V (Kåvepenin) and erythromycin (Ery-Max) in these infections.Hovelius et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_10.xlsx |
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Document reference: 49041 |
Study title: An open, randomized trila to evaluate if dose and frequency given bt American Heart Association coul be reduced (250 000 units x3 for 10 days)for streptococcal pharyngitis.Breese et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_3.xlsx |
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Document reference: 49034 |
Study title: Compare the effect of treatment with penicillin V in children with AOM for 5 and 10 days respectively and to investigate whether a higher dose of penicillin V is associated with a beneficial result.Ingvarsson et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_11.xlsx |
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Document reference: 49042 |
Study title: Determine concentration of pcV in serum and in middle ear exudate and to isolate bacteria in the ear exsudate during the course of treatment with penicillin V in acute otitis media in children.Ingvarsson et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_15.xlsx |
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Document reference: 49046 |
Study title: determine concentration of pcV in serum and in middle ear exudate at various intervals of administration of different doses and to correlate the susceptibility in vitro of H Infl to pcVKamme et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_5.xlsx |
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Document reference: 49036 |
Study title: Double-blinded, Randomized parallel groups design trial, the primary objective of the study was to evaluate the taste of two formulations of phenoxymethylpenicillin suspension in children. The secondary objectives were to study age-related differences in taste perception, to evaluate the acceptability of the suspensions, and to determine patient compliance.Bagger-Sjöbäck et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_12.xlsx |
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Document reference: 49043 |
Study title: Evaluate in children the taste of two different phenoxymethylpenicillins, one containing aspartame.Norstedt |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_13.xlsx |
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Document reference: 49044 |
Study title: Investigate how absorption is influenced by volume, composition and food intake.Forsman et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_1.xlsx |
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Document reference: 49031 |
Study title: Investigate how absorption is influenced by volume, composition and food intake.Forsman et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_1.xlsx |
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Document reference: 49032 |
Study title: investigate serum concentrations achieved with potassium salt of penicillin V i n2 different galenic forms.Perlhagen et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_2.xlsx |
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Document reference: 49033 |
Study title: Investigate the minimum age limit in children accepting penicillin administered as tablets instead of mixture.Edvardsson et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_14.xlsx |
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Document reference: 49045 |
Study title: Investigate the possibility to administer penicillin V in a twice daily dosage regimen.Edlund et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_6.xlsx |
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Document reference: 49037 |