Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients
研究概览
简要总结
The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.
详细描述
This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who complain of cancer pain and who require administration of hydromorphone HCl - Patients who can follow the requirements of the overall study, including completion of filling out the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, at the investigator's discretion - Signed informed consent
排除标准
- •Patients who received strong continuous narcotic analgesics (eg morphine, fentanyl, oxycodone, hydromorphone) within 4 weeks prior to administration of the study drug - Patients who have a medical history of receiving drugs in the past or currently, or of drug abuse - Patients who did not agree to conduct the approved methods for contraception during the study - Patients who have sustained injuries in physical functions or diseases which may cause abnormalities in absorbing the study drug, excessive accumulation and metabolic or elimination disorder - Patients who are receiving Monoamine Oxidase Inhibitors (MAO) inhibitors or who are within 2 weeks from discontinuation - Patients who need to be excluded based on precautions in the user manual of the study drug, notice and contradictions, at the investigator's discretion
研究组 & 干预措施
Hydromorphone HCI OROS
干预措施: Hydromorphone HCI OROS (Drug)
结局指标
主要结局
The ratio of patients with % PID (Pain Intensity Difference) over 30% of patients from the first evaluation date until the third evaluation date, following the administration of hydromorphone HCI to cancer pain patients
时间窗: Baseline and at approximately Day 57
次要结局
- Changes in the Karnofsky Performance Rating Scale (KPRS)(Baseline, and at approximately Days 29 and 57)
- Change in pain relief (%)(Baseline, and at approximately Days 29 and 57)
- Frequency of awakening(Baseline, and at approximately Days 29 and 57)
- Level of sleep inconvenience(Baseline, and at approximately Days 29 and 57)
- Satisfaction with sleep(Baseline, and at approximately Days 29 and 57)
- Quality of life assessment measured by the EORTC QLQ-C15 PAL(Baseline, and at approximately Days 29 and 57)
- Investigator's Global Assessment(At approximately Days 29 and 57)
- Patient's Global Assessment(At approximately Days 29 and 57)
- CGI-I (Clinical Global Impression - Improvement)(At approximately Days 29 and 57)