EUCTR2004-004395-36-BE进行中（未招募）不适用
A Multi-Centre, Open Label, Follow-on Study to Assess the Maintenance of Effect, Tolerance and Safety of Sativex in the Treatment of Subjects with Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 416
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
- •1. Subject is willing and able to give informed consent for participation in the study (see Section 15.2)
- •2. Male or female, aged 18 years or above
- •3. Subject has participated in a GW clinical study to investigate the effects of Sativex on their neuropathic pain and has completed the study. This must have been within the last seven days
- •4. Subject has complied with all of the study requirements in the preceding GW parent study, including the completion of diary cards and study questionnaires
- •5. Subject has shown tolerability to the study medication in a preceding GW study
- •6. Subject is expected, in the opinion of the investigator, to gain clinical benefit from receiving Sativex therapy
- •7. Subject is willing and able (in the investigators opinion) to comply with all study requirements, including the completion of diary cards and study questionnaires
- •8. Subject is willing for his or her name to be notified to the responsible authorities for participation in this study, according to local laws and regulations
- •9. Subject is willing to allow his or her primary care physician and consultant, if appropriate, to be notified of participation in the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has uncontrolled diabetes with HbA1c blood levels of more than 11% at Visit 1 (Day 0)
- •2. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying disease
- •3. Any know or suspected history of alcohol or substance abuse
- •4. Any history of epilepsy or recurrent seizures
- •5. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication
- •6. Subject has evidence of cardiomyopathy
- •7. Subject 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 subject at risk of a clinically relevant arrhythmia or myocardial infarction
- •8. Subject has a QT interval; of > 450 ms (male) or > 470 ms (females) at Visit 1
- •9. Subject has a secondary or tertiary AV block or sinus bradycardia (HR < 50 bpm) or sinus tachycardia (HR >110 bpm) at Visit 1
- •10. Subject has a diatolic blood pressure of < 50 mmHg or > 105 mmHg in a sitting position at rest for 5 minutes prior at Visit 1
- •11. Subject has impaired renal function i.e., creatinine clearance is lower than 50 ml/min at Visit 1
- •12. Subject has significantly impaired hepatic function, at Visit 1, in the investigator's opinion
- •13. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter
- •14. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
- •15. Subjects who have received an IMP within the 12 weeks before Visit 1 (except the prerequisite study medication from the GW parent study
- •16. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study
- •17. Following a physical exam, the subject has any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study
- •18. Unwilling to abstain form donation of blood during the study
- •19. Subjects previously entered into this study
研究者
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