EUCTR2015-000944-41-IT进行中（未招募）1 期
A PILOT STUDY TO TEST THE FEASIBILITY OF A TWO-ARM, DOUBLE BLIND, PARALLEL-GROUP, RANDOMIZED CONTROLLED TRIAL FOR THE COMPARISON OF THE DURATION OF THE ANALGESIC EFFICACY OF A SINGLE MATRIX TRANSDERMAL FENTANYL PATCH COMPARED VS A DOUBLE MATRIX TRANSDERMAL FENTANYL PATCH . - FenS-FenD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pain due to active oncological disease
- •Age = 18 years
- •Pain treatment with stable dosage of Durogesic® in the previous six days, in need of substituting the patch at or before 60 hours of treatment.
- •Pain controlled (average pain intensity in the previous 24 hours = 4/10)
- •rescue medications for the treatment of breakthrough pain for a maximum of three daily KPS = 50
- •Written informed consent to study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients using 12,5 mcg/h patch size
- •Radiation therapy and/or chemotherapy within 15 days prior to enrollment
- •Cognitive deficits compromising the ability to assess pain or pain relief
- •Pregnancy or breastfeeding
- •Severe hepatic and/or renal impairment
- •Participation in other clinical trials that might interfere with the study results
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