Study title: A randomised double blind nultiple-dose study comparing the efficacy and tolerability of Iburprofen versus Paracetamol (both syrup formulations) in the treatment of fever in children known with febrile convulsions
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases [C10] | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: IBUPROFEN | |||||
ATC code: | |||||
Document link: ibuprofen- br1178-vanEsch.xls | |||||
Document date: 2013-07-25 | |||||
Study number: BR1178 | |||||
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 | - |