A 5-day, Multicentre, Randomized, Open-label, Parallel Group, Active Control Pilot Study to Evaluate the Efficacy and Safety of OxyNorm® (Oxycodone Hydrochloride Injection) in Comparison With Morphine Sulfate Through the IV Continuous Infusion Regimen in Patients With Cancer Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.
研究概览
简要总结
The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.
详细描述
5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged 19 years or more
- •Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
- •Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
- •Subjects who voluntarily signed the Informed Consent Form for the study
- •Subjects who are capable of understanding details of the study and verbal communication on pain intensity
排除标准
- •Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)
- •Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
- •Patients who have contraindications and cautions when study drugs administered.
研究组 & 干预措施
Oxycodone Hydrochloride
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
干预措施: Oxycodone Hydrochloride (Drug)
Morphine Sulphate
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
干预措施: Morphine Sulphate (Drug)
结局指标
主要结局
Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.
时间窗: 5 days
For the pain assessment value for efficacy assessment, Subjects perform pain grading through Numeric rating score(NRS) from 1 to 10 for the mean pain intensity over the past 7 days at Screening, and mean pain intensity over the past 24 hours at Baseline (Day 0), Day 1, Day 2, Day 3, Day 4, Day 5. Verbal measurement can be conducted by subjects without using visual data. '0' indicates 'no pain', and as the number increases, the pain gets more severe, and '10' indicates the worst pain.
次要结局
- Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration(5 days)
- Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization(5 days)
- Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization(5 days)