Study title: A single dose study to compare the efficacy and side effects of ibuprofen suspension to placebo in children 5 through 11 years of age with post-operative pain secondary to either inguinal or umbilical herniorrhaphy. CSR 187 Revised. Protocol 90-048, Unpublished Report 385.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia | |||||
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 90-048.pdf | |||||
Document date: 2011-09-27 | |||||
Study number: 90-048 | |||||
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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