The Efficacy and Safety of Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Moderate to Severe Cancer Pain：A Multicenter Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 916
- 试验地点
- 1
- 主要终点
- The proportion of patients with effective pain relief
研究概览
简要总结
The goal of this real world study is to observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets in the treatment of moderate to severe cancer pain participants in real clinical practice.
After entering the study, participants will take Oxycodone Hydrochloride Sustained-release Tablets. The investigators need to observe and record relevant data, and finally analyze and summarize the data to understand the efficacy and safety.
详细描述
This study is a prospective, single arm, multicenter real world study, the investigators didn't set up a control group. After the participant is enrolled, the participant will enter a 14 day treatment cycle, where the medication will be proportionally converted into Oxycodone Hydrochloride Sustained-release Tablets. The daily medication dose will be adjusted based on the number of pain outbreaks and pain scores (According to the drug increment principle of NCCN), and various information (Daily oxycodone dose, average pain score, minimal pain score, most severe pain score, number of breakout pain, name of rescue drugs, number of rescue, heart rate, blood pressure, respiratory rate, SPO2, combination of drugs, pain control satisfaction, etc) about the participant's medication will be recorded. The participant will not be limited to whether to combine medication. Observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
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
- •Voluntarily sign an informed consent form;
- •Age ≥ 18 years old;
- •Patients with moderate to severe (NRS ≥ 4 points) cancer pain;
- •Patients with oral equivalent Oxycodone Hydrochloride Sustained-release Tablets ≥ 80mg/d.
排除标准
- •Patients with severe mental illness who cannot cooperate with follow-up
结局指标
主要结局
The proportion of patients with effective pain relief
时间窗: From the 1st to 14th day of treatment
Effective pain relief is defined as a decrease of 30% or more in average pain intensity from day 1 to day 14 compared to the baseline period.
Mean difference in pain intensity after treatment
时间窗: From the 1st to 14th day of treatment
Use the Numeric Rating Scale（NRS, 0 to 10 points, lower scores indicate better pain control） to evaluate the average pain score per day over the past 24 hours. Calculate the daily difference in pain intensity (PID) by subtracting the daily NRS score from the baseline NRS score. Divide the sum of PID on days 1 to 14 by 14 to obtain the mean difference in pain intensity (MPID).
次要结局
- The proportion of patients with effective pain control(From the 1st to 14th day of treatment)
- The improvement of patient symptoms(On the 3rd, 7th, and 14th days after treatment)
- The satisfaction with pain control(On the 3rd, 7th, and 14th days after treatment)
- The time for the patient's pain to be effectively controlled(From the 1st to 14th day of treatment)