Study title: Multicentre, randomised, comparative double-blind and double placebo study in two parallel groups, of the efficacy and safety of ketoprofen (0.5 mg/kg/dose), versus ibuprofen (5 mg/kg/dose), in repeated doses, in the treatment of febrile conditions in children aged 1 year to 6 years.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Musculoskeletal Diseases | |||||
Brands: Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: KETOPROFEN | |||||
ATC code: | |||||
Document link: Ketoprofen-Study 3.pdf | |||||
Document date: 2011-10-17 | |||||
Study number: Doc. Ref. N°4.5 (KET 396 501) | |||||
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) |
- | - | Y | Y | - |