A Verification Study of JNS020QD in Patients With Post-herpetic Neuralgia, Complex Regional Pain Syndrome (CRPS) or Postoperative Pain Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of fentanyl in opioid-naive participants with post-herpetic neuralgia, complex regional pain syndrome or post-operative pain syndrome who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).
详细描述
This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with post-herpetic neuralgia (intense, typically intermittent pain along the course of a nerve caused by the varicella zoster virus), complex regional pain syndrome or post-operative pain syndrome. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 22, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive one-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) of either fentanyl at the dose ranging from 12.5 to 50 microgram/hour or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. 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 whose pain because of post-herpetic neuralgia, Complex Regional Pain Syndrome (CRPS) or post-operative pain syndrome is continuing for at least 12 weeks prior to informed consent
- •Participants who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or at a certain dose (except the use on an as-needed base) on consecutive days or participants who are continuously taking an analgesic adjuvant with a certain dosage and administration (except the use on an as-needed base) for at least 14 consecutive days prior to informed consent
- •Participants showing insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and to requiring a continuous opioid analgesic as per the Investigator or Sub-investigator
- •Participants with an average pain intensity of 50 millimeter or more on the Visual Analog Scale in 24-hour daily living prior to informed consent
- •Participants who can be hospitalized to the 4th day after the initiation of titration period
排除标准
- •Participants who had an operation that may affect the assessment within 30 days before informed consent
- •Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)
- •Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe respiratory function disorders
- •Participants complicated with hepatic dysfunction such as fulminant hepatitis (inflammation of the liver) and liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs), or renal impairment such as nephritic syndrome, acute renal failure, and chronic renal failure
- •Participants with a history of hypersensitivity to fentanyl and other opioid analgesics
研究组 & 干预措施
Fentanyl (Titration period)
One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which will be increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose will be increased up to maximum of 50 mcg/hr. The treatment will continue for 10-29 days and then the eligible participants from this group will be randomly assigned to either of the two groups in the double-blind period.
干预措施: Fentanyl (Drug)
Fentanyl (Double-blind period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, will be administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which will be same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will be continued for 12 weeks.
干预措施: Fentanyl (Drug)
Placebo (Double-blind period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, will be administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) will be gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo will be gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will continue for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
时间窗: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)
Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.
次要结局
- Pain Visual Analog Scale (VAS) Score - Titration Period(Day 12-14 (Screening period) and Day 27-29 (Titration period))
- Pain Visual Analog Scale (VAS) Score - Double-Blind Period(Day 27-29 (Titration period) and Day 83-85 (double-blind period))
- Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period(Day 1 and 29 or final evaluation (Titration period))
- Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period(Day 1 and 85 or final evaluation (double-blind period))
- Number of Doses of Rescue Treatment Per Day - Titration Period(Day 1 and 29 or final evaluation (Titration period))
- Number of Doses of Rescue Treatment Per Day - Double-Blind Period(Day 1 and 85 or final evaluation (double-blind period))
- Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period(Day 1 and 29 or final evaluation (Titration period))
- Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period(Day 1 and 85 or final evaluation (double-blind period))
- Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period(Day 1 and 29 or final evaluation (Titration period))
- Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period(Day 1 and 85 or final evaluation (double-blind period))
- Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period(Day 29 or final evaluation (Titration period))
- Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period(Day 1 and 85 or final evaluation (double-blind period))