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    【ChiCTR-TNRC-09000742】Efficacy of TTS-fentanyl given after weak opioid in patients with cancer related pain without stabilization phase: An open label study

    基本信息
    登记号

    ChiCTR-TNRC-09000742

    试验状态

    暂停或中断

    药物名称

    /

    药物类型

    /

    规范名称

    /

    首次公示信息日的期

    2009-08-13

    临床申请受理号

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    靶点

    /

    适应症

    Cancer pain

    试验通俗题目

    Efficacy of TTS-fentanyl given after weak opioid in patients with cancer related pain without stabilization phase: An open label study

    试验专业题目

    Efficacy of TTS-fentanyl given after weak opioid in patients with cancer related pain without stabilization phase: An open label study

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    临床试验信息
    试验目的

    To assess the efficacy of TTS-fentanyl given after weak opioid in patients with cancer related pain without stabilization phase.

    试验分类
    试验类型

    非随机对照试验

    试验分期

    其它

    随机化

    Non-randomized, single group

    盲法

    /

    试验项目经费来源

    Department of Anaesthesia and Intensive Care, CUHK

    试验范围

    /

    目标入组人数

    72

    实际入组人数

    /

    第一例入组时间

    2009-09-01

    试验终止时间

    2014-09-05

    是否属于一致性

    /

    入选标准

    1. With pain secondary to cancer; 2. Must have a histologically confirmed malignancy that has either recurred after potentially curative therapy or is not amenable to curative therapy at presentation; 3. Must have pain caused by the presence of malignant disease; 4. Must require analgesic according to Step III of the WHO analgesic ladder; 5. Have cancer-related pain with average 24hour pain score > 4; 6. Aged >= 18 years; 7. Estimated life expectancy of at least 3 months; 8. Ability to communicate effectively with the study personnel about the nature of their pain and be able to complete their diary; 9. Ability to read and sign informed consent; 10. Women of childbearing age must take adequate contraception.；

    排除标准

    A patient will be excluded from the study if he/she has any of the following: 1. A history of opioid allergy; 2. A history of narcotic abuse prior to the diagnosis of cancer; 3. Active skin disease that precludes the use of transdermal patches; 4. Clinically relevant CO2 retention (e.g. COPD); 5. Abnormal laboratory values*: 6. Serum bilirubin level > 34 umol/L (>2.0 mg/ dL); 7. Serum creatine >177 umol/L (> 2.0 mg/dL); 8. Any co-existing neuropathic pain; 9. Receiving regular treatment with an strong opioid for their pain before entering the study; 10. Received radiation therapy or changes in hormonal and/or chemotherapy within 7 days prior to study entry; 11. Participated in an investigational drug trial 30 days prior to the selection; 12. Any co-existing medical condition that is likely to interfere with the study process; 13. Palliative Performance Scale (PPS) of less than 70.；

    研究者信息
    研究负责人姓名
    试验机构

    Chinese University of Hong Kong

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

    Chinese University of Hong Kong的其他临床试验

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