A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer-related Pain
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 800
- 试验地点
- 15
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
Clinical study GWCA0999 is a six month, Phase III, non-comparative, follow-on study to evaluate the safety of long-term Sativex therapy in patients with advanced cancer.
Primary Objective is to evaluate the safety of long-term Sativex therapy when used as an adjunctive (not breakthrough) measure in patients with advanced cancer.
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Secondary Objectives are to assess the maintenance of effect through long-term usage of Sativex as adjunctive therapy for the relief of uncontrolled persistent chronic cancer related pain.
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’ & ’maintenance of effect’ 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 65 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
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient has completed the parent study within the last seven days
- •Willing and able to give written informed consent
- •Willing and able to comply with all study requirements.
排除标准
- •The patient is currently using cannabis or cannabinoid based medications, other than the parent study IMP, and is unwilling to abstain for the duration of the study
- •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 substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer)
- •Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year)
- •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
- •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
Incidence of adverse events (AEs)
时间窗: Incidence of adverse events (AEs)
次要结局
- Columbia Suicide Severity Rating Scale (C-SSRS)(Time Frame: 6 months)
- Vital Signs(Time Frame: 6 months)
- Hematology and Biochemistry Assessments(Time Frame: 6 months)
- Weekly average NRS Pain(Time Frame: 6 months)
- Weekly average Sleep Disruption NRS(Time Frame: 6 months)
- Constipation NRS(Time Frame: 6 months)
- Patient Satisfaction Questionnaire (PSQ)(Time Frame: 6 months)