Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- sedation/drowsiness
研究概览
简要总结
Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Cancer patients with metastatic disease
- •Adult (older than 18 years)
- •Life expectancy of > 3 months
- •Cancer-related pain > 3 on an 11 point Numerical Rating Scale (NRS)
- •In the need of opioids (step II or III)
- •Able to use nasal drugs.
- •Women of child bearing potential using adequate contraception
- •Informed consent given according to applicable requirements before any trial-related activities. Trial-related activities are any procedure that would not have been performed during the routine management of the patient
排除标准
- •History of substance abuse
- •Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
- •Treated with MAO inhibitor within the last 14 days
- •Known hypersensitivity to study drug or specific contraindications to the study drug
- •Nasopharyngeal device such as gastric tube
- •Concomitant participation in any other trials dealing with pain with an investigational drug or device apart from cancer treatment within 14 days prior to inclusion in this trial
- •Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
- •Sleep apnoea syndrome
- •Pregnant or breastfeeding women
- •Psychiatric disease
研究组 & 干预措施
fentanyl
cancer patients with pain
干预措施: fentanyl (Drug)
结局指标
主要结局
sedation/drowsiness
时间窗: 10 days
scores on a 0-10 numerical rating scale; 0=none / 10=intolerable
nausea and vomiting
时间窗: 10 days
nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no
次要结局
- pain intensity(10 days)