A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
2013年9月10日 更新者：Janssen Pharmaceutical K.K.
Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia
The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.
研究概览
详细说明
This is a multicenter (study conducted at multiple sites), open label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel-group (each group of participants will be treated at the same time) study.
Approximately, 60 participants will be enrolled in the study.
This study will consist of a screening phase (maximum 14 days), an observation phase (92 days), and a follow-up phase (98 days).
Participants will be randomly assigned to treatment group A, B, or C.
During the observation phase, participants will receive injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in the deltoid muscle or gluteal muscle as applicable on Days 1, 8, 36, and 64 alternating between sides (left/right).
Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, injection site reaction, drug-induced extrapyramidal symptoms scale, and visual analog scale which will be evaluated throughout the study.
The total study duration for each participant will be approximately 190 days.
研究类型
介入性
注册 (实际的)
76
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:- Participants had to have the capability to provide informed consent in writing to participate in the study
- Participants with a diagnosis of schizophrenia in accordance with the diagnostic criteria for Diagnostic and Statistical Manual of Mental Disorders -IV-TR (DSM-IV-TR)
- Participants whose psychiatric symptom is considered stable by the investigator/subinvestigator at the time of giving informed consent
- Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) in the following 9 items at screening: delusion, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility, uncooperativeness, poor impulse control
- Participants with an experience of taking a risperidone formulation or a paliperidone formulation by 8 days before the initial day (Day 1) of the study treatment
Exclusion Criteria:- DSM-IV-TR diagnosis other than schizophrenia
- DSM-IV-TR diagnosis of substance-related disorders within 180 days before the date of screening
- At a risk of suicide or other-injurious behavior as considered by the investigator/subinvestigator , and participants with a history of suicide attempts
- Concurrent condition of Parkinson's disease (except for drug-induced extrapyramidal syndrome) - Concurrent condition or history of symptomatic cerebrovascular accident
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Treatment A
Participants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
|
Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
其他名称：
|
|
实验性的：Treatment B
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
|
Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
其他名称：
|
|
实验性的：Treatment C
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64.
|
Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
其他名称：
|
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 |
|---|---|---|
|
Plasma concentration of unchanged drug (Paliperidone palmitate)
大体时间：Days 1 to 190
|
Days 1 to 190
|
|
|
Plasma concentration of active metabolite (paliperidone)
大体时间：Days 1 to 190
|
Days 1 to 190
|
|
|
Plasma concentration of enantiomer of paliperidone palmitate (R078543)
大体时间：Days 1 to 190
|
Days 1 to 190
|
|
|
Plasma concentration of enantiomer paliperidone palmitate (R078544)
大体时间：Days 1 to 190
|
Days 1 to 190
|
|
|
Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate
大体时间：Days 1 to 190
|
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
|
Days 1 to 190
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate
大体时间：Days 1 to 190
|
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
|
Days 1 to 190
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of paliperidone palmitate
大体时间：Days 1 to 190
|
The Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) is a measure of the plasma paliperidone concentration from time zero to end of dosing interval.
It is used to characterize drug absorption.
|
Days 1 to 190
|
|
Number of participants with adverse events
大体时间：Up to Day 190
|
Up to Day 190
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
大体时间：Screening, Baseline (Day 1), Days 8, 36, 64, and 92
|
The PANSS is a medical scale that assesses various symptoms of schizophrenia.
The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology).
The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Higher scores indicate worsening.
|
Screening, Baseline (Day 1), Days 8, 36, 64, and 92
|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score
大体时间：Screening, Baseline (Day 1), Days 8, 36, 64, and 92
|
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.
A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants".
Higher scores indicate worsening.
|
Screening, Baseline (Day 1), Days 8, 36, 64, and 92
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年4月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2010年3月1日
研究注册日期
首次提交
2013年9月10日
首先提交符合 QC 标准的
2013年9月10日
首次发布 (估计)
2013年9月16日
研究记录更新
最后更新发布 (估计)
2013年9月16日
上次提交的符合 QC 标准的更新
2013年9月10日
最后验证
2013年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.