A Randomized, Double-Blind, Active Controlled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Once-daily Compared With Oxycodone HCL Controlled-release Twice Daily in Subjects With Cancer Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 主要终点
- Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in participants with cancer-related pain.
详细描述
This is a double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug is assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), comparative, parallel-group (a clinical trial comparing the response in two or more groups of participants receiving different treatments) study of OROS hydromorphone HCl compared with oxycodone HCl controlled-release in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain. The study will consist of 3 phases: a screening period (up to 14 days before randomization), a dose titration phase (up to 8 days), and a dose maintenance phase (28 days). The study visits will be scheduled at weekly intervals. Eligible participants will be randomly assigned to receive either hydromorphone HCl once daily or oxycodone HCl twice daily (placebo will be administered when necessary for blinding). During titration phase, dosage of hydromorphone HCl or oxycodone HCl will be adjusted upward or downward to achieve stable pain control. It can be from 2 days to 8 days. Participants who complete dose titration will enter into the dose maintenance phase and will receive study treatment for 28 consecutive days. Morphine hydrochloride will be given as rescue analgesic (drug used to control pain) medication for breakthrough pain during the study. Primarily efficacy will be evaluated by measuring change in the score of Brief Pain Inventory (BPI) questionnaire item 'worst pain' at end of maintenance period. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants receiving strong oral or transdermal (through the skin) opioid analgesics with inadequate control of moderate to severe (very serious, life threatening) cancer pain or who presented with cancer pain and will be eligible to move to Step 3 of the WHO analgesic ladder when receiving weak opioids
- •Participants who require or are expected to require between 40 mg and 184 mg of oral morphine or morphine equivalents every 24 hours for the chronic management of cancer pain
- •Participants who are reasonably expected to achieve a stable dose of opioid study medication during the study
- •Participants who are not expected to start a course of chemotherapy, radiotherapy, targeted cancer therapy, hormone therapy or diphosphates therapy after enrolment into the study. If participants are receiving long-term treatment including hormone therapy, target cancer therapy and diphosphate, the treatment should be kept stable as much as possible from 2 weeks before randomization and up to the completion of the study, encompassing the titration and maintenance phases
- •Female participants who are premenarchal, postmenopausal, or surgically sterile, abstinent or if sexually active, they must use a medically acceptable method of contraception and must be willing to continue to use the same method of contraception throughout the study
排除标准
- •Participants with neuropathic pain or pain of unknown origin, or acute pain - Participants having pain only on movements
- •Participants requiring other opioid analgesics (apart from morphine hydrochloride (HCl), in immediate release formulation, allowed as rescue medication for breakthrough pain)
- •Participants with a recent history (within the previous 6 months) or current history of drug abuse or alcohol abuse
- •Women of childbearing potential who were pregnant or lactating, seeking pregnancy or failing to use an adequate contraceptive method
研究组 & 干预措施
OROS Hydromorphone hydrochloride (HCl)
OROS Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioid dose.
干预措施: Hydromorphone HCl (Drug)
OROS Hydromorphone hydrochloride (HCl)
OROS Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioid dose.
干预措施: Placebo (Drug)
Oxycodone HCl Controlled release (CR)
Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.
干预措施: Oxycodone HCl CR (Drug)
Oxycodone HCl Controlled release (CR)
Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29
时间窗: Baseline and Day 29
The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.
次要结局
- Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29(Baseline and Day 29)
- Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29(Baseline and Day 29)
- Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29(Baseline and Day 29)
- Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29(Baseline and Day 29)
- Breakthrough Pain Medication (Rescue Medication) Doses Taken(Baseline up to Day 29)