ISRCTN38250575已完成未知
A double blind, randomised, placebo controlled parallel group study of cannabis based medicine extract (CBME), in the treatment of peripheral neuropathic pain characterised by allodynia
GW Pharma Ltd (UK)0 个研究点目标入组 145 人开始时间: 2005年11月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 145
研究概览
简要总结
2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17997224 (added 26/09/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patient or legal representative is willing and able to give informed consent for participation in the study (if the patient is unable to read or to sign the document, consent procedures as detailed in the Declaration of Helsinki must be followed)
- •2. Male or Female, aged 18 years or above
- •3. Chronic peripheral neuropathic pain of at least 6 months duration
- •4. Presence of mechanical allodynia within the territory of the affected nerve(s)
- •5. Evidence of sensory change in the affected nerve by simple clinical tests
- •6. Pain with a severity score of 4 or more on at least 4 completed BS-11 scores in the baseline week
- •7. Stable dose of current analgesic medication for at least 2 weeks prior to study entry
- •8. Female patients of child bearing potential and male patients whose partner is of child bearing potential are willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- •9. Willing for his or her names to be notified to the Home Office for participation in this study
- •10. Willing to allow his or her General Practitioner and Consultant, if appropriate, to be notified of participation in the study
- •11. No cannabinoid use (cannabis, Marinolâ or Nabilone) at least 7 days before Visit 1 and willing to abstain from any use of cannabis during the study
- •12. Able (in the Investigator?s opinion), and willing to comply with all study requirements
排除标准
- •1. History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
- •2. Concomitant severe non-neuropathic pain or the presence of cancer related neuropathic pain or neuropathic pain resulting from diabetes mellitus
- •3. Known history of alcohol or substance abuse
- •4. Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure
- •5. History of epilepsy
- •6. Female patient who is pregnant, lactating or planning pregnancy during the course of the study
- •7. Male patient who is currently receiving and unwilling to stop sildenafil (Viagra®) and unwilling to stop for the duration of the study
- •8. Regular levodopa therapy within 7 days of study entry
- •9. Significant renal or hepatic impairment
- •10. Known or suspected hypersensitivity to cannabinoids
- •11. Scheduled elective surgery or other procedures requiring general anaesthesia during the study
- •12. Terminal illness
- •13. 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
- •14. Travel outside the UK planned during the study
- •15. Donation of blood during the study
- •16. Patients who have participated in another research study in the past 12 weeks
- •17. Patients previously randomised into this study
研究者
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