A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 109
- 主要终点
- Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline
研究概览
简要总结
The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic 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
- 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
- •The patient has advanced active cancer for which there is no known curative therapy.
- •The patient is able (in the investigators opinion) and willing to comply with all study requirements.
- •The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
- •The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the World Health Organization (WHO) analgesic ladder.
- •The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.
排除标准
- •The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain.
- •Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- •Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug.
- •The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure).
- •The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.
研究组 & 干预措施
Sativex Low Dose
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
干预措施: Sativex Low Dose (Drug)
Sativex Medium Dose
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
干预措施: Sativex Medium Dose (Drug)
Sativex High Dose
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
干预措施: Sativex High Dose (Drug)
结局指标
主要结局
Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline
时间窗: 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)
A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening.
次要结局
- Change in Cumulative Average Pain Response Curves(Baseline to end of treatment (Week 5))
- Change in Mean Daily NRS Pain Score (Average Pain).(5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5))
- Change in Mean Daily NRS Pain Score (Worst Pain).(5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5))
- Change in Sleep Disruption NRS(5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5))
- Change in Brief Pain Inventory - Short Form (BPI-SF)(Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination))
- Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)(Baseline (Visit 2) and End of Treatment (Week 5 or premature termination))
- Change in Patient Global Impression of Change - PGIC(End of Week 5)
- Change in Montgomery Asberg Depression Rating Scale (MADRS)(Baseline and End of Treatment (Week 5 or premature termination))