A PHASE IV STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF OXYCODONE ORAL SOLUTION IN PEDIATRIC AND ADOLESCENT SUBJECTS
This is a Phase iV study to characterize the pharmacokinetics and to evaluate the safety of oxycodone oral Solution administered to pediatric and adolescent subjects following a surgical procedure. it is an open-label, multicenter study conducted at up to 10 sites. Subjects will be enrolled preoperatively up to 14 days before surgery with the expectation that they will require iV access after the surgery for at least 24 hours and postoperative analgesia with an opiate-level medication. after dosing with oxycodone oral Solution subjects will be carefully monitored for safety. a total of 110 pediatric and adolescent male or female subjects will be enrolled, including a minimum of 20 subjects under age 2, 30 ages 2 to 6 years, 30 ages 7 to 12 years and 30 ages 13 to [Less Than]17 years. Subjects within each age group will be evenly distributed by age and gender.
The study will consist of a Screening period within 14 days of surgery; a predose check in (Day [?]1); a treatment period after surgery (Day 1, Time Zero) an end of Study assessment. The total duration of the study, excluding Screening, will be approximately 1 full day.
eligible subjects who will have study assessments performed at Screening. Following surgery, subjects will receive standard care, including parenteral analgesia with a nonoxycodone, nonoxymorphone medication that will not interfere with the measurement or metabolism of oxycodone. at this time (during Day [?]1), they will have a predose check-in to have eligibility confirmed.
after subjects ages 2 to [Less Than]17 years have been postoperatively cleared to transition to oral pain medication, oxycodone oral Solution will be administered at Time Zero of Day 1 in place of the standard analgesic medication. The first 10 subjects in each of the 2 to 6, 7 to 12 and 13 to [Less Than]17 age groups, who will be included in the first interim analysis, will only receive 1 dose of oxycodone oral Solution. Subjects in these age groups enrolled in the study after the interim analysis is completed may receive additional doses every 4-6 hours as needed. if pain control is inadequate with oxycodone oral Solution, the investigator may administer an iV dose of ketorolac (0.5 mg/kg) every 6 hours or an iV dose of Morphine Sulfate (0.1 mg/kg) every 4 hours as rescue medication for breakthrough pain after dosing. use of other rescue pain medication is permissible in accordance with hospital pain management guidelines or facilities standard of care. any rescue medications used will be provided by the study site pharmacy.
after subjects under age 2 have been postoperatively cleared to transition to oral pain medication, they will receive a single dose of oxycodone oral Solution at Time Zero of Day 1 in place of the standard analgesic medication. The dose will be determined based on PK modeling from the interim analyses. if pain control is inadequate with oxycodone oral Solution, as indicated by a score of moderate to severe (4-10) on the FLaCC pain scale (Faces, Legs, activity, Crying and Consolability), the subject will be given Fentanyl via nCa. The Fentanyl will be provided by the study site pharmacy.
Subjects will undergo an end-of-Study assessment at least 24 hours after dosing with oxycodone oral Solution. at that time, if the study staff determines that it is safe to do so, subjects will be discharged from the study. Subjects who discontinue the study for any reason will not be replaced.
1.Is male or female <17 years of age at the time of dosing.
2.Is generally healthy defined as American Society of Anesthesiologists (ASA) Physical Status classification grade I or II (except for the condition for which the procedure is being performed), documented by medical history; physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; electrocardiogram; clinical laboratory assessments general observations.
3.Has a negative urine pregnancy test predose (for females of childbearing potential).
4.Is an outpatient prior to admission for a surgical procedure and is expected to remain hospitalized for at least 24 hours after dosing with study drug.
5.Is anticipated to have postsurgical pain requiring a parenteral analgesic regimen using a short-acting opioid analgesic and is anticipated to be switched to an oral opioid for at least 1 dose (according to institution standard of care).
6.Has an indwelling access catheter for blood sampling.
7.Agrees to comply with all protocol requirements. If not old enough, the legally responsible parent(s) or legal guardian(s) must agree to comply with all protocol requirements.
8.Has been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s) or legal guardian(s) and the subject, respectively, in accordance with institutional review board requirements.