Study title: A Factorially-Designed Analgesic Efficacy Study Comparing Combinations of Acetaminophen in Doses of 325 mg, 500 mg, and 1000 mg and Dextromethorphan Hydrobromide in Doses of 5 mg, 15 mg and 30 mg, with the Components Alone and Placebo in Post-Operative Dental Pain.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: DEXTROMETHOPRHAN AND PARACETAMOL | |||||
ATC code: | |||||
Document link: dextromethorphan_paracetamol 96-626.pdf | |||||
Document date: 2011-11-23 | |||||
Study number: 96-626 | |||||
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 |