Study title: A phase IV multicenter clinical investigation of the safety and efficacy of APAP 1000 mg (total daily dose of 4 grams), ibuprofen 400 mg (total daily dose of 1200 mg), and placebo in the management of the symptoms of primary dysmenorrhea. Stat Rpt 73. Protocol 4-400, Unpublished Report 193.
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 4-400.pdf | |||||
Document date: 2011-09-27 | |||||
Study number: 4-400 | |||||
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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