EUCTR2011-001140-30-CZ进行中（未招募）不适用
Randomized, placebo-controlled study of Fentanyl Ethypharm for breakthrough pain in opioid-treated patients with cancer. - ETHYFY
aboratoires Ethypharm0 个研究点目标入组 136 人开始时间: 2011年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
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
- •1.Written informed consent form obtained;
- •2.Is at least 18 years of age;
- •3.Has a documented diagnosis of a malignant solid tumor or a hematological malignancy causing cancer-related pain;
- •4.Has an Eastern Cooperative Oncology Group (ECOG) performance status rating ?3;
- •5.Has a life-expectancy of at least 2 months;
- •6.Has been receiving between 60 mg and 1000 mg of oral morphine daily, or at least 25 µg/hour of transdermal fentanyl or at least 30 mg of oxycodone daily, or 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for cancer-related pain at a stable dose for at least a week;
- •7.Has a stable background pain intensity =4/10 in the pain scale for at least a week;
- •8.Experiencing on average, 1 to 4 episodes of breakthrough pain per day that are adequately controlled with a stable dose of standard rescue medication, of which the patient will have an adequate supply throughout the study;
- •9.Is willing and able (personally or with the help of a caregiver) to:
- •a.Evaluate and record pain intensity and pain relief and,
- •b.Record adverse events and,
- •c.Record each intake of study drug and rescue medication in a patient’s diary and,
- •d.Return diaries and study drugs at each visit
- •10.If female of childbearing potential (i.e. not surgically sterile or ?1 year after the onset of amenorrhea due to menopause):
- •a.Has a negative urinary pregnancy test and,
- •b.Is not breastfeeding and,
- •c.Agrees to practice a reliable form of contraception or abstinence during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Hypersensitivity to fentanyl or to any of the excipients;
- •2.Is using intrathecal opioids;
- •3.Has recent history of substance abuse or neurologic or psychiatric impairment that would compromised data collection;
- •4.Has had recent therapy (within 30 days) or will receive a planned therapy during the study that would alter pain or response to analgesics during the study such as palliative radiation therapy or a nerve block;
- •5.Has a known moderate or severe hepatic or renal disease*;
- •6.Has received any other investigational new drug within 30 days before the first study drug administration;
- •7.Has sleep apnea or active brain metastases with increase intracranial pressure;
- •8.Is at risk of increased opioid side effects because of prior or concomitant medications (such as CYP3A4 inhibitors, partial opioid agonists/antagonists);
- •9.Is at risk of significant bradyarrythmia because of underlying heart disease;
- •10.Has primary source breakthrough pain that is not cancer related;
- •11.Treated by Mono Amine Oxydase Inhibitor (MAOI), or last MAOI intake within last 2 weeks;
- •12.Has a severe chronic obstructive pulmonary disease or severe respiratory depression.
研究者
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