A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Summed pain intensity difference at 30 min
研究概览
简要总结
Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent in the treatment of breakthrough cancer pain.
详细描述
Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.
This study will compare the time of onset and degree of pain relief of Nasalfent to that of Placebo. The safety of the two treatments groups (Nasalfent, Placebo) will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Able and willing to give consent
- •Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception
- •Diagnosis of cancer
- •Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain
- •Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication
- •Able (or via caregiver)to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary
- •Able to be up and about for 50% of the day or greater
排除标准
- •Intolerance to opioids or fentanyl
- •rapidly increasing/uncontrolled pain
- •pain that is not cancer related
研究组 & 干预措施
Nasalfent, Fentanyl Citrate Nasal Spray
干预措施: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) (Drug)
Placebo Spray
干预措施: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) (Drug)
结局指标
主要结局
Summed pain intensity difference at 30 min
时间窗: 30 min after dosing
次要结局
- SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief(Various timepoints)