An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants
2013年5月10日 更新者：Janssen Pharmaceutical K.K.
Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain
The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.
研究概览
详细说明
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain.
The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week.
The treatment period will consist of titration period (from the initiation of the study treatment to determination of the individual's maintenance dose) and maintenance period (from completion of the titration period to the completion of the treatment period).
An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety.
Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily.
Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively.
Participants' safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
91
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aichi、日本
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Amagasaki、日本
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Chiba、日本
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Chiba N/A、日本
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Chikushi、日本
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Edogawa、日本
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Fukuoka、日本
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Fukushima、日本
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Hiratsuka、日本
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Kawasaki、日本
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Koto、日本
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Matsudo、日本
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Meguro、日本
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Minato-Ku、日本
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Niigata、日本
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Niigata N/A、日本
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Osaka、日本
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Sagamihara、日本
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Shibuya、日本
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Shinjuku-Ku、日本
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Toshima-Ku、日本
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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 及以上 (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 with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
- Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
- Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
- Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
- Participants who are able to visit the medical institutions throughout the study period
Exclusion Criteria:
- Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
- Participants with current or a history of epilepsy or seizure disorders
- Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
- Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
- Participants with moderate to severe liver dysfunction or severe renal dysfunction
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks.
Dose will be adjusted as per Investigator's discretion.
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实验性的：Tapentadol Hydrochloride
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Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks.
Dose will be adjusted as per Investigator's discretion.
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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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Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
大体时间：Baseline, Week 12
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Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.
The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
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Baseline, Week 12
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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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Change From Baseline in 11-point Numerical Rating Scale (NRS)
大体时间：Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.
The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
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Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
大体时间：Week 12
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Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders.
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.
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Week 12
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Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
大体时间：Week 8, Week 12
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The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention.
The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
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Week 8, Week 12
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Number of Participants With Response Based on Physician's Global Assessment Scale
大体时间：Week 8, Week 12
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Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "not effective".
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Week 8, Week 12
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Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
大体时间：Baseline, Week 12
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BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life).
Item 1 for presence of pain assesses the question: "Do you have any pain today other than everyday kinds of pain?" on a 2-point scale of "yes" or "no".
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Baseline, Week 12
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Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
大体时间：Baseline, Week 12
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BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life).
Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).
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Baseline, Week 12
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
大体时间：Baseline, Week 12
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BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life).
Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine.
Negative change indicates an improvement in pain.
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Baseline, Week 12
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Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
大体时间：Baseline, Week 12
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Sleep Latency was addressed by the question: "How long after bedtime/lights out did you fall asleep last night?"
and the change from Baseline in sleep latency was reported.
Decrease in time indicated improvement.
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Baseline, Week 12
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Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
大体时间：Baseline, Week 12
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Time slept was addressed by the question: "How long did you sleep last night?"
and the change from Baseline in time slept was reported.
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Baseline, Week 12
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Number of Participants With Awakenings Based on Sleep Questionnaire
大体时间：Baseline, Week 12
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Number of awakenings was addressed by the question: "How many times did you wake up during the night?''
and lesser number signified better sleep.
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Baseline, Week 12
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Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
大体时间：Baseline, Week 12
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Overall quality of sleep was addressed by the question: "Please rate the overall quality of your sleep last night" and participants could choose one of the following options: excellent, good, fair or poor.
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Baseline, Week 12
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Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
大体时间：Baseline, Week 12
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SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary).
Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both.
All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
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Baseline, Week 12
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Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
大体时间：Baseline, Week 12
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WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee.
It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items).
Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96.
Higher scores indicate that a symptom is bothersome and physically disabling.
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Baseline, Week 12
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Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
大体时间：Baseline, Week 12
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RDQ scale is used to assess the impact of low back pain on daily activities by participants.
The scale consists of 24 item questionnaire with options as "Yes"/"No" where "Yes" is counted as 1 point.
The total score ranged from 0 to 24, with higher scores indicating greater disability.
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Baseline, Week 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
大体时间：Week 12
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COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms.
Total score is calculated by adding the scores of all the 11-items.
The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.
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Week 12
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Serum Concentration of Tapentadol
大体时间：Week 2, 4, 8, 12
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Week 2, 4, 8, 12
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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。
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
2010年4月1日
初级完成 (实际的)
2010年12月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2010年4月22日
首先提交符合 QC 标准的
2010年5月13日
首次发布 (估计)
2010年5月17日
研究记录更新
最后更新发布 (估计)
2013年5月14日
上次提交的符合 QC 标准的更新
2013年5月10日
最后验证
2013年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR016999
- JNS024ER-JPN-N21 (其他标识符：Janssen Pharmaceutical K.K., Japan)
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.