临床试验/NCT02101554

NCT02101554终止4 期

AN OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PF-06412528 IN CHILDREN 7-17 YEARS FOR THE TREATMENT OF MODERATE-TO-SEVERE PAIN

Pfizer19 个研究点分布在 1 个国家目标入组 19 人开始时间: 2015年4月24日最近更新: 2020年7月10日

适应症

干预措施

试验速览

阶段: 4 期
状态: 终止
发起方: Pfizer
入组人数: 19
试验地点: 19
主要终点: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Week 1 to Week 4

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

详细描述

Subjects, once stabilized to Embeda, need only complete a minimum of 2 of the 6 week study duration to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last dose.

研究设计

研究类型: Interventional
主要目的: Treatment
盲法: None

入排标准

年龄范围: 7 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
•Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing.

排除标准

•Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
•Hypersensitivity to morphine, naltrexone.
•A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
•Undergone surgery within 3 days prior to the first day of dosing.

研究组 & 干预措施

Embeda

Experimental

One arm, open label, active

干预措施: Ages 7-11 (Drug)

Embeda

Experimental

One arm, open label, active

干预措施: ages 12-17 (Drug)

结局指标

主要结局

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Week 1 to Week 4

时间窗: Week 1 to Week 4

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Treatment Emergent Treatment Related Adverse Events: Week 1 to Week 4

时间窗: Week 1 to Week 4

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. Relatedness to PF-06412528 was assessed by the investigator.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Week 5 to Week 10

时间窗: Week 5 to Week 10

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Screening Before Day 1

时间窗: At Screening (2 weeks before Day 1 of study)

COWS is a clinician-administered instrument, to assess participants' clinical opiate withdrawal level. The scale ranges from 0 (none symptoms) to 48 (severe symptoms), higher score = more severe withdrawal. Scores category: 0 to 4 = none to minimal, 5 to 12 = mild, 13 to 24 = moderate, 25 to 36 = moderately severe withdrawal and 37 to 48 = severe withdrawal. Participants experiencing a COWS score greater than equal to (\>=) 13 is treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment. In this outcome measure, participants as per COWS score categories are reported. Only those COWS categories are presented which had at least 1 participant for any reporting arm.

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Day 1 of Week 5

时间窗: Day 1 of Week 5

Number of Participants With Treatment Emergent Adverse Events According to Severity: Week 1 to Week 4

时间窗: Week 1 to Week 4

An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function).A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Treatment Emergent Adverse Events According to Severity: Week 5 to Week 10

时间窗: Week 5 to Week 10

An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 4

时间窗: Week 4

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Early Termination Before Week 4

时间窗: Early Termination before Week 4 (anytime between Week 1 to Week 4)

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 8

时间窗: Week 8

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Early Termination Before Week 10

时间窗: Early Termination before Week 10 (anytime between Week 5 to Week 10)

Number of Participants With Treatment Emergent Treatment Related Adverse Events: Week 5 to Week 10

时间窗: Week 5 to Week 10

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Day 1

时间窗: Day 1 (Pre-dose)

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 2

时间窗: Week 2

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 3

时间窗: Week 3

Average Concentration at Steady-state (Css, av) of PF-06412528

时间窗: Anytime post-dose on Visit 4 (Week 4)

Css, av was defines as the average steady state concentration of a drug ("steady state" has been achieved when the rate of drug administration and the rate of drug elimination are equal).

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 1

时间窗: Week 1

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Screening on Week 5

时间窗: Screening before treatment started at Week 5

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 6

时间窗: Week 6

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 10

时间窗: Week 10

Apparent Oral Clearance (CL/F) of PF-06412528

时间窗: Anytime post-dose on Visit 4 (Week 4)

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

次要结局

Number of Participants With Pre-defined Criteria of Vital Signs(Week 1 up to Week 10)
Number of Participants With Laboratory Test Abnormalities(Week 1 up to Week 10)
Apparent Volume of Distribution (Vz/F) of PF-06412528(Anytime post-dose on Visit 4 (Week 4))
Dose-Exposure Relationship of Metabolites of Morphine, Naltrexone and 6-β-Naltrexol(Anytime post-dose on Visit 4 (Week 4))

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (19)

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