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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

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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

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

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

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