Fda request endo pharmaceuticals10/2/2023 ![]() To participate in the PK Period, subjects had: Had been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s)/legal guardian(s) and subject, respectively, in accordance with IRB requirements. Were able to provide pain assessment evaluations using age-appropriate instruments provided in the protocol.Subjects with postsurgical pain were prescribed a parenteral analgesic regimen utilizing a short-acting opioid analgesic AND were anticipated to be switched to an oral opioid for an extended period of time (according to institutions standard of care).Intraoperative (prior to surgical incision) labs were acceptable provided the results had been reviewed by the investigator for study eligibility prior to dosing. Had laboratory results from within 21 days prior to Baseline available including clinical chemistry and hematology laboratory analytes.Were able to swallow oxymorphone ER tablets.Had chronic pain (malignant and/or nonmalignant) or postsurgical pain expected to require ATC opioid analgesia for up to 12 weeks with at least 10 mg per day oxymorphone ER (approximately equal to 30 mg per day oral MSE).For the purpose of this study, all menstruating females were considered to be of childbearing potential unless they were biologically sterile or surgically sterile for more than 1 year. Females of childbearing potential had to be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). Were males or females 7 - ≤17 years of age.Why Should I Register and Submit Results?.
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