A Double Blind, Randomized, Parallel Group, Placebo Controlled, Comparative Study of the Efficacy, Safety and Tolerability of Cannabis Based Medicine (CBM) Extracts in Patients With Cancer-related Pain.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
研究概览
简要总结
The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.
详细描述
This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).
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
- •Willing and able to give informed consent.
- •Male or female, age 18 years or above.
- •Diagnosed with cancer of any type, which is considered to be terminal.
- •Diagnosed with cancer-related pain which is not wholly alleviated with their current strong opioid treatment and whose level of pain measured on a NRS is ³four on at least one occasion per day, during the two day run-in period, leading up to visit
- •On strong opioid maintenance therapy for at least seven days prior to the screening visit.
- •Willing to abstain from any use of cannabis during the study, other than the study medication.
- •No cannabinoids use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabis during the study.
- •Clinically acceptable blood results at the screening visit.
- •Able (in the investigators opinion) and willing to undertake and comply with all study requirements.
- •Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation.
- •Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only).
排除标准
- •Know history of substance misuse.
- •Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
- •Received any epidural analgesia within 48 hours prior to study entry.
- •Either received, within two weeks of study entry, or due to receive chemotherapy or radiotherapy during the study.
- •Unable to give informed consent.
- •History of any type of schizophrenia, any other psychotic illness, a serious personality disorder, or other significant psychiatric illness other than depression associated with their chronic pain and/or in response to the underlying condition.
- •Currently taking levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®).
- •Had a serious cardiovascular disorder, including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia.
- •Significant renal or hepatic impairment, who in the opinion of the investigator, were unsuitable for treatment with study medication.
- •History of epilepsy.
- •Had oral cavity cancers or whose previous treatments had included radiotherapy to the floor of the mouth.
- •Female subjects who were pregnant or lactating or of child-bearing potential and were inadequately protected against conception during the study and for three months thereafter.
- •Male subjects who were sexually active and who were not using adequate forms of contraception during the study and for three months thereafter.
- •Subjects who had participated in a clinical research study in the past four weeks, prior to study entry.
- •Planned travel outside the UK during the study (applicable to the UK centres only).
- •Subjects who, in the opinion of the investigator, were unsuitable to participate in the study for any other reason, not mentioned in the entry criteria.
研究组 & 干预措施
Placebo
Placebo control
干预措施: Placebo (Drug)
Sativex
Active treatment
干预措施: Sativex® (Drug)
THC Alone
Active treatment
干预措施: THC Alone (Drug)
结局指标
主要结局
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
时间窗: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
The pain NRS was complete at the same time each day, i.e. bedtime in the evening. 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. A negative value indicates an improvement in pain score from baseline.
The Consumption of Escape Analgesic Medication.
时间窗: 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Subjects recorded their use of escape medication each day on their diary card.
次要结局
- Sleep Disturbance 0-10 Numerical Rating Scale(2 weeks: baseline to end of week 2 (last 3 days of treatment))
- Nausea 0-10 Numerical Rating Scale(2 weeks; baseline - end of week 2 (last 3 days of treatment))
- Memory 0-10 Numerical Rating Scale(2 weeks: baseline - end of week 2 (last 3 days of treatment))
- Appetite 0-10 Numerical Rating Scale(2 weeks: baseline - end of week 2 (last 3 days of treatment))
- Concentration 0-10 Numerical Rating Scale(2 weeks: baseline - end of week 2 (last 3 days of treatment))
- EORTC Quality of Life Questionnaire (EORTC-QLQC30)(2 weeks; baseline and end of treatment (2 weeks))
- Brief Pain Inventory Short Form(End of 2 weeks)