EUCTR2004-002531-32-DE进行中（未招募）1 期
A double blind, randomised, placebo controlled, parallel group study of Sativex, in the treatment of subjects with peripheral neuropathic pain associated with allodynia - N/a
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 218
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
- •2. Male or female, aged 18 years or above
- •3. Subject is able (in the investigators opinion) and willing to comply with all study requirements
- •4. Diagnosed with peripheral neuropathic pain of at least 6 months duration and in who pain is not wholly relieved with their current therapy
- •5. Subject must have presence of mechanical allodynia within the territory of the affected nerve(s). This should be confirmed by a positive pain response to either stroking the allodynic area with a SENSELAB brush 05 or to force applied by a 5.07 gram Semmes-Weinstein monofilament.
- •6. Subject must have at least one of the following underlying conditions, which causes their peripheral neuropathic pain;
- •- postherpetic neuralgia, peripheral neuropathy, focal nerve lesion, or complex regional pain syndrome (CRPS) type 2. Note: CRPS type 1 is excluded
- •7. Stable dose of regular pain medication and non-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willing for these to be maintained throughout the study. Where patients are taking a medication containing paracetamol please refer to section 8.3
- •8. Has the subject, in the opinion of the investigator, received or is currently receiving the appropriate peripheral neuropathic pain treatments for their condition
- •9. Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries
- •10. Willing to allow his or her general practitioner 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. Concomitant pain thought by the investigator to be of a nature or severity to interfere with the subject's assessment of their peripheral neuropathic pain
- •2. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study
- •3. CRPS type 1, cancer related neuropathic pain or neuropathic pain resulting from diabetes mellitus
- •4. Subjects who haveused within the last year, or who are currently using, either cannabis (either for recreational or medical purposes) or cannabis based medicines and who are unwilling to abstain for the duration of the study
- •5. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
- •6. Any Known or suspected history of alcohol or substance abuse
- •7. Any history of epilepsy or recurrent seizures
- •8. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication
- •9. Subject has evidence of cardiomyopathy
- •10. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction withinthe 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
- •11. Subject has a QT interval of > 450 ms (males) or > 470 ms (females) at visit 1
- •12. Subject has a secondary or tertiary AV block or sinus bradycardia (HR < 50 bpm) or sinus tachycardia (HR > 110 bpm) at visit 1
- •13. Subject has a diastolic blood pressure of < 50 mmHg or >105 mmHg in a sitting position at rest for 5 minutes prior to randomisation
- •14. Subject has impaired renal function i.e. creatinine clearance is lower than 50 ml/min at visit 1
- •15. Subject has significantly impaired hepatic function, at visit 1, in the investigators opinion
- •16. 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
- •17. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
- •18. Subjects who have received an IMP within the 12 weeks before visit 1
- •19. 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
- •20. Following a medical exam, the subject has any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study
- •21. Unwilling to abstain from donation of blood during the study
- •22. Travel outside the country of residence planned during the study
- •23. Subjects previously randomised into this study
研究者
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