Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tapentadol Hydrochloride
干预措施: Tapentadol Hydrochloride (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
时间窗: Baseline, Week 12
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.
次要结局
- Number of Participants With Response Based on Overall Quality of Sleep Questionnaire(Baseline, Week 12)
- Change From Baseline in 11-point Numerical Rating Scale (NRS)(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)(Week 12)
- Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale(Week 8, Week 12)
- Number of Participants With Response Based on Physician's Global Assessment Scale(Week 8, Week 12)
- Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale(Baseline, Week 12)
- Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale(Baseline, Week 12)
- Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12(Baseline, Week 12)
- Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12(Baseline, Week 12)
- Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12(Baseline, Week 12)
- Number of Participants With Awakenings Based on Sleep Questionnaire(Baseline, Week 12)
- Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12(Baseline, Week 12)
- Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12(Baseline, Week 12)
- Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12(Baseline, Week 12)