NCT00822614Unknown3 期
The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- AE Profile
研究概览
简要总结
A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate hte Safety of Fentanyl TAIFUN Treatment after titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 Years or older
- •A medically documented diagnosis of cancer
- •Use of a fixed round the clock dose of opioid as maintenance therapy with a dose equivalence of at least 60mg of oral morphine/ day, or at least 25 mcg of transdermal fentanyl/ hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily. Current opioid treatment for at least 7 days prior to randomization
- •Current use of opioid medication for BTP
- •At least 4 episodes of BTP per week, with peak intensity of at least 4 on the NPS at pain onset. No more than 4 BTP episodes per day.
- •PIFR of at least 20L/min
- •Karofsky Performance Status of 40 or better
- •Life expectancy of at least 12 weeks
- •Written Informed Consent
排除标准
- •Uncontrolled or rapidly increasing BTP
- •Symptomatic intracranial tumors or cerebral metastases
- •Persistent symptomatic asthma
- •Patients unable to use the inhaler
- •Inadequate lung function, as defined by PEFR <60%
- •Hypersensitivities, allergies or contraindications to fentanyl or the study medication components
- •A recent history of alcohol or substance abuse (in the past 1 year)
- •Radiotherapy to the thorax within 30 days of the beginning of the titration phase
- •Cognitive impairment or any neurological of psychiatric disease which could compromise the ability of the patient to complete the assessments
- •Participation in any clinical study with an experimental drug within 30 days of randomization
- •Any clinical condition or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug
- •Pre-menopausal women who are not surgically sterile and/or have a positive pregnancy test at baseline visit and/ or are of child bearing potential and are not using a reliable method of birth control or do not plan to continue using this method throughout the study and/or who are nursing
研究组 & 干预措施
Active Comparator
Active Comparator
Current BTP Medication
干预措施: Opioid (Drug)
Fentanyl TAIFUN
Experimental
Titration for dose confirmation followed by observation period
干预措施: Fentanyl TAIFUN (Drug)
结局指标
主要结局
AE Profile
时间窗: 28 Days
To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile
时间窗: 28 days
次要结局
- To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN(28 Days)
- To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose(28 Days)
- To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication(28 Days)
- To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment(28 Days)
研究者
研究点 (1)
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