EUCTR2014-005440-17-DE进行中（未招募）1 期
Tolerability and analgesic efficacy of Loxapine in patients with refractory, chemotherapy-induced neuropathic pain
Private Universität Witten/Herdecke gGmbH0 个研究点目标入组 12 人开始时间: 2015年3月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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
- •- Chemotherapy induced neuropathic pain of at least 3 months refractory to at least one analgesic compound
- •- Neuropathic pain = 4 (11-point numeric pain rating scale) at screening visit (including mixed pain)
- •- Age: =18 years
- •- Body weight between 50 to 150 kg
- •- Given 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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Participation in other interventional studies (current or within the last 3 months)
- •- Parkinson’s disease, movement disorders (extrapyramidal signs and symptoms) associated with antipsychotics, Neuroleptic malignant syndrome, other syndromes associated with antipsychotics
- •- Severe hypotension with a syncope in history, glaucoma, urinary retention, epilepsy or other seizure disorders in history, severe dementia, dementia related psychosis in history, breast cancer in medical history, malignancies with a life expectancy of less than 6 months, other severe and life-threatening diseases
- •- Known drug or alcohol abuse
- •- Concomitant intake of antipsychotics, dopamine agonists (levodopa, bromocriptine, lisuride, pergolide, ropinirole, cabergoline, pramipexole, apomorphine), alpha-receptor blocking compounds or compounds with a known potential for QT interval prolongation
- •- Pregnancy or lactation period
- •- Pre- or perimenopausal females with ineffective contraception
- •- Close affiliation with the investigational site
研究者
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