EUCTR2009-016529-32-CZ进行中（未招募）1 期
A multicenter, non-comparative, open-label extension study to assess the long term safety of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in patients with uncontrolled persistent chronic cancer related pain.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For inclusion in the study patients must fulfill ALL of the following criteria:
- •- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •The patient may not enter the study if ANY of the following apply:
- •- 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), current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug.
- •- 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.
- •- Female patient of child-bearing potential or male patient 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, intrauterine 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).
- •- Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- •- Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study.
- •- Has significantly impaired hepatic function at the 'End of Treatment' Visit of the parent study, this patient should not enter the study. This criterion can only be confirmed once 'End of Treatment' Visit laboratory results are available; patients that entered the study and are later found not to meet this criterion should be withdrawn from the study.
- •If the parent study 'End of Treatment' Visit laboratory results raise any safety concerns, the investigator should consider whether it will be appropriate for the patient to continue to participate in the extension study, or if the patient should be withdrawn.
研究者
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