An Open-label, Multi-center, Non-interventional Study to Investigate Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 648
- 主要终点
- Change in pain intensity score (where 0 is worst and 10 is best) as measured on the Numeric Rating Scale (NRS) from baseline to Day 36
研究概览
简要总结
This study aims to collect clinical information and to examine the usefulness and safety of ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients with drug is as per physician discretion and that doses are determined based upon approved labeling recommendations and physician discretion.
详细描述
The primary purpose of this observational study is to collect clinical data on cancer pain control using OROS (ORal Osmotic Active System) hydromorphone and to investigate the clinical usefulness of OROS hydromorphone for Korean cancer patients. Information on the effectiveness of cancer pain control and any adverse events reported by those patients using OROS Hydromorphone will be reported. In addition, clinical usefulness of OROS hydromorphone will be evaluated through assessing sleep disturbance due to pain, breakthrough pain, and end-of-dose failure before and after the study drug administration and examining the patient's satisfaction with study drug and the investigator's global assessment. This is a multi-center, open-label, prospective, exploratory, and observational study with approximately 770 patients. Efficacy endpoints will be analyzed to examine the difference between before and after the treatment. Since this is an observational study under the condition of routine practice, OROS Hydromorphone dosage should be adjusted at the discretion of the investigator, based on patient response. It is recommended that the dosage be conservative at first and adjusted appropriately considering the adverse events and analgesic effect for all the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 are in need OROS hydromorphone to relieve cancer pain
排除标准
- •Patients with serious gastrointestinal diseases that may interfere with oral analgesic effects, such as dysphagia, vomiting, absence of periastalsis, intestinal obstruction, and/or severe strangulation, in which case the absorption and passage of orally-administered medication may be unduly influenced
研究组 & 干预措施
001
OROS Hydromorphone 8 16 32 mg once a day for 4 weeks
干预措施: OROS Hydromorphone (Drug)
结局指标
主要结局
Change in pain intensity score (where 0 is worst and 10 is best) as measured on the Numeric Rating Scale (NRS) from baseline to Day 36
时间窗: Between Visit 1 (day 1) and the last visit (day 29 ± 7: from day 22 to day 36)
次要结局
- Breakthrough pain experience(between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day)))
- Patient satisfaction with study drug and detailed reason(at the last visit (DAY29 ± 7: from 22 day to 36 day)))
- End-of-dose failure experience(between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day)))
- Change in sleep disturbance(between Visit 1 (DAY 1) and the last visit (DAY29 ± 7: from 22 day to 36 day)))
- Investigator's global assessment(the last visit (DAY29 ± 7: from 22 day to 36 day))
