EUCTR2014-005344-17-DE进行中（未招募）1 期
Oral cannabidivarin (CBDV) solution for treatment of HIV-associated neuropathic pain – a randomized, double-blind, placebo-controlled phase II study. - Cannabidivarin (CBDV) for neuropathic pain in HIV
Department of Anesthesiology and Operative Intensive Care Medicine, Charité (CBF)0 个研究点目标入组 32 人开始时间: 2015年1月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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
- •Male and female patients with chronic, painful HIV-associated neuropathy (NRS-score =4); women who are post-menopausal for more than one year can participate in this study; female patients of child-bearing potential are allowed to participate in this study only if they are permanently sterilised (e.g. tubal occlusion, hysterectomy) or if they provide a negative pregnancy test and are willing to use a highly effective method of contraception (e.g. hormonal contraceptives) during the course of the study and for three months thereafter
- •Age: 18-65 years
- •Body mass index (BMI): 18-30 kg/m2
- •Sufficient knowledge of the German language
- •Signed written informed consent
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Individuals dependent on the sponsor, the trial site or the investigator
- •Individuals housed in institutions due to official or judicial orders
- •Co-incident severe diseases of the central nervous system (e.g. dementia)
- •Co-incident major psychiatric conditions
- •Acute disorders with functional limitations and/or limitations of neurological assessment
- •Limited mental capacity or knowledge of the German language
- •Chronic or previous abuse of recreational drugs, drugs and/or alcohol
- •Pregnancy and lactation as well as planning pregnancy during the course of the study and for three months thereafter
- •Men and women of childbearing potential not using adequate contraception during the clinical trial and three months thereafter
- •Intolerance to the study medication or to one of the components of the study medication
- •Hepatic diseases where:
- •- the level of ALT exceeds three times the upper limit of normal or the level of AST exceeds three times the upper limit of normal and the bilirubin exceeds two times the upper limit of normal or the INR exceeds 1,5 times the upper limit of normal
- •- the levels of ALT or AST exceeds three times the upper limit of normal in combination with symptoms (fatigue, nausea, vomiting, pain or tenderness in the right upper quadrant of the abdomen, fever, rash, and/or eosinophilia)
- •- the levels of ALT or AST alone exceed eight times the upper limit of normal
- •- the levels of ALT or AST alone exceed five times the upper limit of normal longer than two weeks
- •Chronic renal insufficiency (with significant deviating levels of normal)
- •EKG-Parameters outside following reference ranges: PR-interval: 120 ms (lower limit), 220 ms (upper limit); QRS-duration: 0 ms (lower limit), 120 ms (upper limit); QT-interval: 0 ms (lower limit), 500 ms (upper limit); QTcF-Interval (males): 0 ms (lower limit), 430 ms (upper limit), QTcF (females): 0 ms (lower limit), 450 ms (upper limit)
- •Clinical significant cardiovascular or metabolic diseases: uncontrollable hypertension (lower limit: 90/40 mmHg, upper limit: 140/90 mmHg (18-45 years), 160/90 mmHg (>45 years)); severe heart insufficiency (NYHA = III); abnormal heart rate (lower limit: 40 min-1 (18-45 years), 50 min-1 (>45 years), upper limit: 90 min-1); heart attack within the past 12 months
- •Active participation in other clinical trials three months before or within this clinical study
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