Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 主要终点
- Brief Pain Inventory (BPI) Average Score at Day 28
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) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.
详细描述
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with histological confirmed malignancy
- •Participant on stable morphine or 25 milligram oxycodone dose equivalent per day. Stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day
- •Life expectancy of at least 3 months
- •Negative urine pregnancy test
- •Participants with signed informed consent
排除标准
- •Participant intolerant or hypersensitive to hydromorphone or other opioid agonist
- •Participant with unstable medical condition
- •Participant with renal dysfunction and liver dysfunction
- •Participant dependence to opiates
- •Inability to take oral medication
研究组 & 干预措施
Osmotic Release Oral System (OROS) Hydromorphone
OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.
干预措施: Osmotic Release Oral System (OROS) hydromorphone (Drug)
结局指标
主要结局
Brief Pain Inventory (BPI) Average Score at Day 28
时间窗: Day 28
The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
Brief Pain Inventory (BPI) Average Score at Baseline
时间窗: Baseline
The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
次要结局
- Number of Participants Given Rescue Pain Medications(Day 28)
- Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician(Day 28)