Phase II Study of JNS024PR in Cancer Pain Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.
详细描述
This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period (3 to 14 days), Fixed dose period (5 days) and Follow-up period (7 days). Tapentadol PR will be administered orally (taken by mouth; to be swallowed) twice daily before meal. For participants previously using opioids, the initial dose of tapentadol PR will be selected depending on the daily dose of opioid at the completion of Screening period. For opioid-naive (moderate to severe cancer pain that is not controlled adequately with non-opioid medications) participants, the initial dose of tapentadol PR will be 25 milligram (mg) twice daily. Participants will receive the same dose of tapentadol PR for the first 2 days of the dose adjustment period and from Day 3, the dose can be titrated as per the Investigator's discretion up to Day 14. After that participants will receive fixed dose regimen for 5 days at the same dose as that used at the end of the dose adjustment period. Efficacy will primarily be evaluated by sustained pain control for the 5 day fixed dose phase. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations [120 milligram per day {mg/day} or less], oxycodone hydrochloride sustained release tablets [80 mg/day or less], fentanyl transdermal [through the skin] application system [4.2 mg or less]) c) had achieved adequate pain control with opioid therapy
- •Opioid naive participants should meet the following criteria from a to b: a) Participants with cancer pain b) should not have received any pain control therapy with opioids (excluding narcotic antagonist analgesics [drug used to control pain])
- •Definite diagnosis of any type of cancer, which has been notified to the participant
- •Participants who can be hospitalized during the treatment period
- •Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter (mm) Visual Analog Scale (VAS) scores appropriately throughout the study
排除标准
- •Participants with bradyarrhythmia (slow, irregular heartbeats)
- •History of mild or moderate traumatic (causing damage, like a toll used to crush tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a tissue [usually because of decreased blood flow]) attack within 1 year before informed consent
- •Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied by disturbance of consciousness
- •Previous or concurrent alcohol dependence or narcotic abuse
- •History of active hepatitis (inflammation of the liver) B or C within 3 months before informed consent
研究组 & 干预措施
Opioid-Naive Participants (Tapentadol PR)
Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
干预措施: Tapentadol PR (Drug)
Opioid-Switch Participants (Tapentadol PR)
Opioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
干预措施: Tapentadol PR (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase
时间窗: Day 15 up to Day 19
Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.
次要结局
- Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale(Baseline (Average of Day -1 and Day 0 morning scores), Day 20)
- Pain Assessment Using Visual Analog Scale (VAS) Score(Baseline and Day 19)
- Percentage of Participants Who Achieve Dose Adjustment(Day 3 up to Day 14)
- Rescue Doses(Day 12, 13, 14, 15, 16, 17, 18 and 19)
- Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy(Baseline up to 7 days after last dose of study treatment)
- Sleep Questionnaire Regarding Time to Sleep and Total Time Slept(Pre-dose (Day 1) and Day 20)
- Sleep Questionnaire Regarding Number of Awakenings(Pre-dose (Day 1) and Day 20)
- Sleep Questionnaire Regarding the Quality of Sleep(Pre-dose (Day 1) and Day 20)
- Patient's Global Impression of Change (PGI-C)(Day 19)