A Two-part, Placebo-controlled, Study of the Safety and Efficacy of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Relieving Uncontrolled Persistent Chronic Pain in Patients With Advanced Cancer, Who Have Inadequate Analgesia Even With Optimized Chronic Opioid Therapy.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 540
- 试验地点
- 8
- 主要终点
- Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRS
研究概览
简要总结
Clinical study GWCA1103 is a Phase III therapeutic confirmatory study, of up to 11 weeks duration, to be carried out in patients with advanced cancer and who are experiencing cancer-related pain that is not fully alleviated by their current opioid therapy. They are patients who are likely to have a limited life expectancy. GWCA1103 is a two-part (Part A and B), placebo-controlled, study of the safety and efficacy of Sativex oromucosal spray (Sativex®; Nabiximols). The study’s primary objective is to evaluate the efficacy of Sativex, compared with placebo, when used as an adjunctive measure, in relieving uncontrolled persistent chronic pain (not breakthrough pain) in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
In xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India thousands of cases related to cancer pain are reported every year. This molecule has been studied previously and there are no concerns with respect to the safety profile of the molecule. The conduct of this study in India will help generate data on safety & efficacy of Sativex. The data will support the use of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patients with advanced cancer who have inadequate analgesia even with optimized chronic opioid therapy.
This trial is likely to benefit about 162 patients that will participate in the study and further may provide a new treatment to patients with cancer pain if the molecule is found to be successful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The patient has advanced cancer for which there is no known curative therapy.
- •The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
- •The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations
- •The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
- •The patient is using no more than one type of break-through opioid analgesia.
排除标准
- •Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
- •The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
- •Has experienced myocardial infarction or clinically significant 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 significant arrhythmia or myocardial infarction 4.Has significantly impaired renal function
- •Has significantly impaired hepatic function
- •Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective).
结局指标
主要结局
Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRS
时间窗: Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRS
次要结局
- Percentage improvement in NRS average pain score from baseline to the end of treatment(Time Frame: 7 weeks)
- Mean 11-point NRS worst pain score from baseline to the end of treatment(Time Frame: 7 weeks)
- Mean sleep disruption NRS score from baseline to the end of treatment(Time Frame: 7 weeks)