title: [Outcomes of an Independent Clinical Study to Compare Branded and Generic Formulations of Sustained-Release Oxycodone].
abstract: To evaluate the potential for the adoption of a generic formulation of sustained-release oxycodone(Oxycodone SR Capsules), an independent clinical study was planned to accurately evaluate the efficacy and safety during a 9-day period. After a 3-day pretreatment period, the generic formulation was administered to patients with progressive cancer, who had been treated with a branded formulation(OxyContin®Tablets)of the drug for 5 days at the same dose. This was followed by a 1- day observation period. Drug administration to 3 patients with pulmonary cancer achieved the primary(dose, pain level, and adverse drug reactions)and secondary(rescue dose frequency and quality of life)endpoints, as well as safety goals. The merits of adopting a different dosage form were also noted. Independent data collection using an appropriate evaluation method consequently promoted the understanding of generic opioids in the clinical setting.
authors.affiliation: Dept. of Pharmacy, Hitachi Ltd, Hitachi General Hospital.
authors.forename: Mai
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Saito
authors.forename: Yurika
authors.initials: Y
authors.lastname: Onodera
authors.forename: Masayo
authors.initials: M
authors.lastname: Okawa
authors.forename: Kei
authors.initials: K
authors.lastname: Shimizu
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Yamamoto
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nawa
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Aoyama
mesh_terms: D000368:Aged; D001859:Bone Neoplasms / Q000556:secondary*; D000072716:Cancer Pain / Q000188:drug therapy* / Q000209:etiology; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D010098:Oxycodone / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D016568:Drugs, Generic; D010098:Oxycodone