Study title: A double-blind single dose evaluation of the efficacy and safety of acetaminophen 1000 mg, ibuprofen 200 mg, ibuprofen 400 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 52. Protocol 4-403, Unpublished Report 164.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia | |||||
Brands: | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: IBUPROFEN AND PARACETAMOL | |||||
ATC code: | |||||
Document link: ibuprofen_paracetamol 4-403.pdf | |||||
Document date: 2011-09-27 | |||||
Study number: 4-403 | |||||
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) |
- | - | - | - | - |