A Randomized, Open-Labeled, Multi-Center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Comparing With Morphine SR in Cancer Pain Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhone HCl compared to twice daily morphine SR, in Taiwan participants with cancer pain. The study consists of 3 phases: Screening phase (14 days before administration of study drug), Dose titration phase (3 to 14 days) and Dose maintenance phase (14 days). This study will include 8 visits (Visit 1 [Day 1], Visit 2 [Day 1-13 telephonic], Visit 3 [Day 14], Visit 4 [Day 15 to Day 21 telephonic], Visit 5 [Day 22], Visit 6 [Day 23 to 27 telephonic] and Visit 7 [Day 28]). In dose titration phase, participants will be randomly assigned to 1 of the 2 treatments, OROS hydromorphone or morphine SR and dose of study medication will be adjusted every 48 hours at Investigator's discretion according to participant's analgesic (drug used to control pain) requirements. Morphine HCl will be used as rescue medication (maintained at 3 doses per day or less) for breakthrough pain. Participants primarily will be evaluated for equivalence of efficacy using the "worst pain" item of the brief pain inventory (BPI). Participants' safety will be monitored throughout the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with cancer pain and experiencing inadequate pain control on or approaching Step 2 of the World Health Organisation (WHO) analgesic ladder
- •Participants with pain scores greater than and equal to 4 on the average in the last 24 hours
- •Participants requiring or are expected to require not more than 540 milligram of oral morphine or morphine equivalent every 24 hours for the management of chronic cancer pain
- •Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial
- •Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial
排除标准
- •Participants with pure or predominantly neuropathic pain or pain of unknown origin (where a mechanism or physical cause cannot be identified)
- •Participants with acute pain or who have pain on movement
- •Participants who have received a fentanyl patch within the last 5 days
- •Participants intolerant or hypersensitive to hydromorphone or other opioids agonists (chemical substance capable of activating a receptor to induce a full or partial response)
- •Participants with recent past history (within the previous 5 years) or current history of drug abuse or alcohol abuse
研究组 & 干预措施
Hydromprphone Hydrochloride (HCl) OROS
Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase.
干预措施: Hydromprphone Hydrochloride (HCl) OROS (Drug)
Morphine Sustain Release (SR)
Participants will receive morphine SR 8 mg every 24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.
干预措施: Morphine Sustain Release (SR) (Drug)
结局指标
主要结局
Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14
时间窗: Day 14
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
BPI Questionnaire Item 3 "Worst Pain" Score at Day 28
时间窗: Day 28
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 "Worst Pain" will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
次要结局
- BPI Questionnaire Item 6 "How Much Pain You Have Right Now" Score(Baseline, Day 14, Day 22 and Day 28)
- BPI Questionnaire Item "Pain Intensity" Score(Baseline, Day 14, Day 22 and Day 28)
- BPI Questionnaire Item "Pain Relief" Score(Baseline, Day 14, Day 22 and Day 28)
- BPI Questionnaire Item "Pain Interference" Score(Baseline, Day 14, Day 22 and Day 28)
- Patient's Global Assessment on Effectiveness(Day 14, Day 22 and Day 28)
- Investigator's Global Assessment on Effectiveness(Day 14, Day 22 and Day 28)
- Number of Times the Pain Medication Required for Breakthrough Pain(Baseline up to Day 28)
- Mean Total Daily Dose (TDD) of Study Medication(Baseline up to day 28)