Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate efficacy of a twice daily dosage regimen in the treatment of acute otitis media. The study was comparative against amoxIcillin suspension.Albertini et al. (1987-09-11)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Bacterial Infections and Mycoses | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: AMPICILLIN | |||||
ATC code: J01CA01 | |||||
Document link: EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_26.xlsx | |||||
Document date: 2015-02-23 | |||||
Study number: 806-47 AC 011-1 | |||||
EudraCT number: | |||||
Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
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