NCT00279344已完成3 期
A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 220
- 主要终点
- Primary:
研究概览
简要总结
Primary objectives:
- To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment
- To assess the safety of FITpatch compared to standard opioid treatment
Secondary objectives:
- To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment
- To assess Quality of life reported with FITpatch compared to standard opioid treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above
- •Subject informed consent given.
- •Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
- •No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
- •No impaired respiratory function nor neurological or psychiatric impairment.
- •No known abuse of drug, narcotic or alcohol.
- •Not pregnant or nursing.
- •Not hypersensitive/allergic to fentanyl or morphine.
- •No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness.
- •Not participating in other clinical trials.
排除标准
- •All exclusion criteria must be answered No for a patient to participate in the trial.
- •Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches?
- •Does the patient have a known abuse of drug, narcotic or alcohol?
- •Is the patient pregnant or nursing?
- •Has the patient neurological or mental impairment that may compromise data collection?
- •Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication?
- •Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness?
- •Does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?
结局指标
主要结局
Primary:
To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment
次要结局
- Secondary:
- To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment
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