Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Adverse drug reaction
研究概览
简要总结
Buprenorphine transdermal patch is newly available in Taiwan in June 2017, the trade name is Transtec, and the available dosages are 35 μg/h and 52.5 μg/h. Taiwan is the first Asia country which launched Transtec for cancer pain treatment. Although the efficacy of transdermal buprenorphine has been demonstrated in some randomized, placebo-controlled studies and also conducted a large scale post-marketing surveillance study in Germany, therefore the local scientific data is required for Asia experience. Due to above rationale, this observational study will be initiated in Taiwan, to build up the first real-world scientific data in Asia.
The objective of this study is to collect the safety and effectiveness of transdermal buprenorphine in routine clinical practice, in particular, to collect data in population with controlled cancer pain and stable titration from previous opioid analgesics in Taiwan.
详细描述
The objective of this observational study is to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec 35 μg/h and 52.5 μg/h) under regular and routine clinical conditions in Taiwan for cancer patients with moderate to severe cancer pain (NRS Score>=4) and strong opioids are needed for their pain treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients aged 20 years old and over
- •Moderate or severe pain intensity with stable titration from previous opioid analgesics, 7 days at least prior to enrolment and with the dose equivalent to oral morphine ranging from 60 to 120 mg/day in previous treatment
- •Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
- •Patients who are going to start Transtec treatment per clinical judgment, according to the locally approved labeling, are eligible.
- •Patients who are able to communicate and fill out the questionnaire forms
- •Patient provided signed informed consent
排除标准
- •Patients diagnosed with non-cancer pain or unexplained pain
- •Patients who have constipation (CTCAE grade 3 and above)
- •Patients with uncontrolled or unstable cardiac disease
- •Abnormal lab results, with obvious clinical significance, such as ALT or AST>= 3 fold of upper limit of normal value or liver function of Child C grade prior to study
- •ALT or AST >= 5 fold of upper limit of normal value for patients with liver metastasis or primary liver cancer
- •Pregnant or nursing (lactating) women
- •Patients who are drug or alcohol abuse
- •Patients who have hypersensitivity to buprenorphine
- •Patients who are clinically unstable or have a life expectancy of less than 8 weeks making completion of the trial unlikely
- •With any contraindications or using prohibited medication per locally approved
结局指标
主要结局
Adverse drug reaction
时间窗: Week 3 to Week 4 or early termination
Number and percentage of patients with adverse drug reactions and serious adverse drug reactions
次要结局
- Pain intensity and interference(whole study-1 month)
- Treatment discontinuation and associated reasons(during study period-1 month)
- Daily pain intensity measured by a numerical rating scale (NRS) by patients(1 month)
- Quality of sleep of the patients(1 month)
- Number of breakthrough pain(1 month)
- Quality of life of the patients(1 month)