A Prospective, Open-Label, Multicenter, Single-Arm, Interventional Study to Evaluate the Efficacy and Tolerability of Once-Daily Oros Hydromorphone for Cancer Pain Treatment in Korean Cancer Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Number of patients with 50% or more average Pain Intensity Difference (PID) from 1st evaluation day (Day 1) to the 2nd evaluation day (Days 15±2)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily OROS ("Osmotic Release Oral System" [a controlled release oral medication delivery system in the form of a tablet]) hydromorphone for cancer pain treatment in Korean cancer patients.
详细描述
This is a prospective (expected to happen), open-label (type of clinical study in which both the researchers and participants know which treatment is being administered), multicenter (conducted at multiple centers), single-arm (only one group), study to evaluate the effectiveness and tolerability (capable to tolerate) of Once-Daily OROS hydromorphone for cancer pain treatment. This is a 14-week study consisting of 2-week efficacy evaluation period (1st evaluation on Day 1 and 2nd evaluation on Days 15±2) and a 12-week extension phase. 99 patients will receive Once-Daily OROS hydromorphone for 2 weeks .After 2 weeks, if a patient has continuous cancer pain and the investigator deems it necessary to administer the same medicine as the study medication then the patient may participate voluntarily in the 12 weeks extension phase. At the extension phase, other continuous-type strong opioid analgesics (painkiller) may be administered at the same time for the adjustment of cancer pain based on the discretion of the investigator.
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
- •Cancer pain and require opioid analgesics
- •Average pain intensity measured at the baseline (patient's medical status before any treatment or research is done) for the past 24 hours over Numeric Rating Scale (NRS) is 4
- •Never taken continuous-type strong opioid analgesics
- •Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control
排除标准
- •Acute digestion related disease, such as dysphagia (difficulty in swallowing), vomiting, no enterokinesia (movements of intestine), intestinal obstruction, acute intestinal stricture (narrowing of a passageway)
- •Expected to undergo radioactive treatment (radiation therapy) between Day 1 and Day 15 of study
- •Being administered with monoamine oxidase inhibitor (eg, moclobemide, selegiline, toloxatone, etc) or within 2 weeks of administration thereof
研究组 & 干预措施
OROS hydromorphone
Once-Daily OROS (Osmotic release oral system [a controlled release oral drug delivery system in the form of a tablet]) hydromorphone
干预措施: OROS hydromorphone (Drug)
结局指标
主要结局
Number of patients with 50% or more average Pain Intensity Difference (PID) from 1st evaluation day (Day 1) to the 2nd evaluation day (Days 15±2)
时间窗: up to 17 days
Average pain intensity is calculated (on 1st and 2nd evaluation days) for the past 24 hours of the patient using the NRS (Numeric Rating Scale) (0 = No pain, 10 = Unimaginably acute pain). PID (pain intensity difference) %= \[NRS (1st evaluation day) - NRS (2nd evaluation day)\]/ NRS (1st evaluation day).
次要结局
- Korean Brief Pain Inventory (K-BPI) scores(up to 17 days)
- European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) scores(up to 17 days)
- Patient's Global Assessment (PGA) scores(up to 17 days)
- Investigator's Global Assessment scores(up to 17 days)