An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain (Palladone)
A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain
研究概览
详细说明
Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analgesics have been studied in children. The benefits to the subjects include contribution of knowledge that will provide for appropriate dosing regimen recommendations for future pediatric subjects.
Treatment consisted of both parenteral and oral hydromorphone. For up to 48 hours immediately following surgery, subjects were administered hydromorphone by IV PCA pump. Dosing with the oral hydromorphone HCl began when the subject was ready to take clear oral liquid. Subjects were administered oral hydromorphone HCl every 6 hours for up to 9 doses. The investigator determined the timing of the first dose based on each subject's clinical condition.
The duration of the treatment phase was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period).
Efficacy was based on the oral hydromorphone treatment. Adverse events were collected for both the oral and parenteral treatments.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72202
- Arkansas Children's Hospital
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California
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Orange、California、美国、92868
- Children's Hospital of Orange County - Pediatric Subspecialty
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Stanford、California、美国、94305
- Stanford University Medical Center
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Colorado
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Aurora、Colorado、美国、80218
- The Children's Hospital
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Connecticut
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New Haven、Connecticut、美国、06510
- Yale-New Haven Children's Hospital
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Florida
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Miami、Florida、美国、33136
- Jackson Memorial Hospital
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa Hospitals and Clinics
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Missouri
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St. Louis、Missouri、美国、63104
- Saint Louis University - Department of Neurology and Psychiatry
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North Carolina
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Chapel Hill、North Carolina、美国、27599-7221
- The University of North Carolina - CH
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Ohio
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Akron、Ohio、美国、44308
- Children's Hospital Medical Center of Akron
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Texas
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Dallas、Texas、美国、75235
- Children's Medical Center
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Houston、Texas、美国、77030
- Texas Children's Hospital / Baylor College of Medicine
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Houston、Texas、美国、77030
- The University of Texas, Health Sciences Center at Houston
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pediatric subjects aged 28 days to 16 years,
- Prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours),
- Prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.
Exclusion Criteria:
- Prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve,
- Prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone,
- Prospective subjects who have received regional anesthetic blockade OR analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone.
Other protocol-specific inclusion/exclusion criteria may apply.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：≥ 28 Days to < 13 Months
infant and toddler
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
其他名称：
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实验性的：≥ 13 months to < 5 years
young child
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
其他名称：
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实验性的：≥ 5 years to < 12 years
older child
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
其他名称：
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实验性的：≥ 12 years to < 17 years
adolescent
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
大体时间：A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.
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Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only. |
A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
大体时间：Immediately prior to first oral dose, up to 54 hours
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There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability.
Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10.
The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.
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Immediately prior to first oral dose, up to 54 hours
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Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time
大体时间：Immediately prior to first oral dose with potentially up to 54 hours duration.
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Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions.
Each face is 25 x 35 mm with 13 mm between faces.
Each subject was asked to point to the face that reflected his or her pain.
The end points are 0 = no pain and 10 = very much pain.
The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.
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Immediately prior to first oral dose with potentially up to 54 hours duration.
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Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time
大体时间：Immediately prior to first oral dose, up to 54 hours
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The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = "no pain" and 10 = "most pain," was used by children ≥ 12 years of age.
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Immediately prior to first oral dose, up to 54 hours
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合作者和调查者
调查人员
- 首席研究员：Gregory B. Hammer, MD、Stanford University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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