Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
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 Average Numerical Rating Scale (NRS) Score at Week 12
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting after condition has healed).
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), and parallel-group (each group of participant will be treated at the same time) comparison study in Japanese participants with chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia. The duration of study will be 14 weeks. The study consists of 3 parts: Screening (1 Week before study commences on Day 1); Treatment (12 weeks and will include 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 up to12 week]); and Follow-up (1 Week). Tapentadol hydrochloride ER oral tablet or matching placebo will be administered twice daily for 12 weeks. Efficacy of the participants will primarily be evaluated through Numerical Rating Scale (NRS). 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 painful diabetic neuropathy or postherpetic neuralgia continuing for at least 12 weeks before consent
- •Participants with adjuvant analgesics (antidepressants, antiepileptics and diabetic peripheral neuropathy drugs) or non-opioid treatment and dissatisfied with current treatment (in sense of efficacy and/or safety) for at least consecutive 14 days during the 12 weeks before consent
- •Participants have not experienced treatment with conventional opioids, except for the following cases: Short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent; and temporal use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (for example, for antitussive) more than 2 days before consent
- •Mean pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale during 48 hours before consent and the Investigator or Sub-investigator considers that the participant should be treated with an opioid analgesic
- •HbA1c within 4 weeks before consent less than or equal to 11percent (in participants with diabetic neuropathic pain)
排除标准
- •Participants have been treated or treated with a monoamine oxidase inhibitor within 14 days before consent
- •Current or a history of epilepsy or convulsive disorders or hypersensitivity to opioid analgesics
- •Suggested of intracranial hypertension (for example, traumatic encephalopathy)
- •Participants who have complicated condition with uncontrolled or clinically significant arrhythmia, or neuropsychiatric disorders
- •Participants with moderately to severely impaired hepatic function, or severely impaired renal function
研究组 & 干预措施
Tapentadol
Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
干预措施: Tapentadol (Drug)
Placebo
Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12
时间窗: Baseline and Week 12
Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.
次要结局
- Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale(Week 8 and Week 12)
- Number of Participants With Categorical Scores on Physician's Global Assessment Scale(Week 8 and Week 12)
- Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
- Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)(Week 12)
- Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale(Baseline and Week 12)
- Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale(Baseline and Week 12)
- Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12(Baseline and Week 12)
- Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12(Baseline and Week 12)
- Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12(Baseline and Week 12)
- Number of Participants With Awakenings Based on Sleep Questionnaire(Baseline and Week 12)
- Number of Participants With Response Based on Overall Quality of Sleep Questionnaire(Baseline and Week 12)
- Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12(Baseline and Week 12)