A Multicenter Study of the Safety, Tolerability, Effectiveness, and Pharmacokinetics of Oxymorphone HCL Extended-Release Tablets in Pediatric Subjects Requiring an Around-The-Clock Opioid for an Extended Period of Time
概览
- 阶段
- 3 期
- 干预措施
- Oxymorphone hydrochloride (HCl)
- 疾病 / 适应症
- Chronic Pain
- 发起方
- Endo Pharmaceuticals
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Pain Intensity Score using FPS-R
- 状态
- 暂停
- 最后更新
- 5年前
概览
简要总结
The purpose of this study was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a continuous, around-the-clock (ATC) opioid treatment for an extended period.
研究者
入排标准
入选标准
- •Were males or females 7 - ≤17 years of age. 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). 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.
- •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).
- •Had a body weight at least 18 kg.
- •Were able to swallow oxymorphone ER tablets.
- •Had laboratory results from within 21 days prior to Baseline available including clinical chemistry and hematology laboratory analytes. Intraoperative (prior to surgical incision) labs were acceptable provided the results had been reviewed by the investigator for study eligibility prior to dosing.
- •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).
- •Were able to provide pain assessment evaluations using age-appropriate instruments provided in the protocol.
- •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.
- •To participate in the PK Period, subjects had:
- •Been hospital inpatients, expected to be hospitalized for up to 72 hours following the initial administration of oxymorphone ER.
排除标准
- •Had known allergies or sensitivities to oxymorphone or other opioid analgesics.
- •Had a known sensitivity to any component of the oxymorphone ER.
- •Had a life expectancy \<3 months.
- •Was pregnant and/or lactating.
- •Had cyanotic heart disease.
- •Had respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study.
- •Had abdominal trauma that would interfere with absorption of oxymorphone ER.
- •Had increased intracranial pressure.
- •Had a respiratory condition requiring intubation.
- •Had a history of uncontrolled seizures that were not managed with anticonvulsants.
研究组 & 干预措施
Pediatric Age Groups: 7 to ≤12 years
Participants expected to require ATC opioids for an extended period of time
干预措施: Oxymorphone hydrochloride (HCl)
Pediatric Age Groups: 13 to ≤17 years
Participants expected to require ATC opioids for an extended period of time
干预措施: Oxymorphone hydrochloride (HCl)
结局指标
主要结局
Pain Intensity Score using FPS-R
时间窗: 14 Days Post Last Dose
Faces Pain Scale - Revised (FPS-R) self-report measure used to assess pain intensity in participants ages 7 - ≤12 years old, consists of 6 faces, visually representing increasing changes in pain intensity bounded on the left by "no pain" and on the right by "very much pain".
Pain Intensity Score using NRS-11
时间窗: 14 Days Post Last Dose
Numerical Rating Scale (NRS-11) is an 11-point categorical numerical rating scale to assess pain intensity in participants ages 13 - ≤17 years old. The scale is anchored on the left with "No Pain" and is anchored on the right with "Worst Possible Pain".