Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 主要终点
- Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain
研究概览
简要总结
The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants with cancer.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) dose-ascending study to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance caused by cancer pain.Total duration of study will be 3 weeks. The study consists of 3 phases: Screening phase (up to 1 week), Treatment phase (2 weeks), and Extension phase (12 weeks). The study will include 6 visits: Day -7, Day 1, Day 15, Day 43, Day 71, and Day 99. During screening phase, potential participants will receive strong oral (long acting) opioid analgesic (for 7 days) until Day 1 and the participants will be evaluated for participation in clinical study on Day 1. During treatment phase, participants will receive hydromorphone OROS (8 milligram [mg] to greater than or equal to 32 mg), once daily for 2 weeks, and the dose will be adjusted every 2 days from Day 3 at the Investigator's discretion and according to the strong oral (long acting) opioid analgesic administered from screening phase to Day 1 (the initial dose of the study drug will be determined by converting the dose of the previously administered analgesic to that of the daily dose of oral morphine with the equivalent analgesic effect to the study drug [dose with equivalent analgesic effect; Hydromorphone OROS dose: oral morphine dose =1:5]). Participants who completed treatment phase and suffer from continuing cancer pain will be enrolled to extension phase and study drug will be administered as per Investigator discretion for 99 days. Participants primarily will be evaluated for improvement in sleep disturbance measured by Korean Brief Pain Inventory (KBPI). Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Participants who are currently receiving strong opioid analgesic (drug used to control pain) for their cancer pain management
- •Participants whose arithmetical mean of sleep disturbance caused by pain measured with Numeric Rating Scale for 3 days before Visit 2 (Day 1) is equal to or greater than 4 points
- •Participants who are able, in the opinion of Investigator, to comply fully with the trial requirements including completion of the Korean-Brief Pain Inventory
- •Participants who have signed an informed consent form
排除标准
- •Participants with pain who are not likely to response to opioid analgesics
- •Participants who are intolerant or hypersensitive to hydromorphone
- •Participants with the following digestive tract diseases which is serious enough to interfere action of an oral analgesic; diseases which can affect absorption and transit of oral drugs such as dysphagia (trouble swallowing), vomiting, no bowel movement, intestinal obstruction, serious intestinal stenosis (narrowing of a duct, tube, or 1 of the valves in the heart), etc
- •Female participants of childbearing potential who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions
- •Participants in whom the risks of treatment with morphine/hydromorphone outweigh the potential benefits, including such risk categories as raised intracranial pressure, hypotension, hypothyroidism, asthma, compromised respiratory function compromised liver function, convulsive (an involuntary contraction or series of contractions of the voluntary muscles) disorder and Addison disease (disorder that occurs when the adrenal glands do not produce enough of their hormones)
研究组 & 干预措施
Hydromorphone OROS
Participants will receive hydromorphone OROS (8 milligram [mg] up to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain
时间窗: Day 15 or Early withdrawal
Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.
次要结局
- Sleep Disturbance Questionnaire: Analgesic Administration(Baseline and Day 15)
- Sleep Disturbance Questionnaire: Frequency of Waking Up(Baseline and Day 15)
- Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain(Baseline and Day 15)
- Korean Brief Pain Inventory (K-BPI) Questionnaire Score(Baseline and Day 15)
- Participant's Pain Intensity(Baseline and Day 15)
- Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain(Baseline and Day 15)
- Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score(Baseline and Day 15)
- Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score(Day 15)
- Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants(Day 15)
- Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators(Day 15)
- Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug(Day 15)
- Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug(Day 15)