A randomised, double-blind controlled trial of ketamine versus placebo in conjunction with best pain management in neuropathic pain in cancer patients - KPS

Greater Glasgow Health Board/University of Glasgow0 个研究点目标入组 214 人开始时间: 2008年6月27日最近更新: 2015年8月4日

试验速览

暂无简介。

•> 18 years of age
•Patient has a histological proven cancer diagnosis
•Written informed consent (to be obtained within 28 days prior to entry into the study)
•Index neuropathic pain (as defined by LANSS) that is related to underlying malignancy or resulting from treatment received for this
•Index neuropathic pain >= 4 on 0-10 (VAS)
•McGill Sensory Scale Score > 5
•Patient has had a trial of at least one adjuvant analgesic (gabapentin, pregabalin, amitriptyline) or has been offered these and declined
•Patient is able to comply with study procedures
•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

•Patients who have received chemotherapy or radiotherapy in the preceding six weeks that is likely to affect neuropathic pain
•Patients who may have a change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study
•Diastolic blood pressure > 100mmHg at screening
•History of seizures in last 2 years
•Patient is currently taking class I anti-arrhythmic drugs
•Life expectancy less than two months
•Patients who are actively hallucinating
•Women of childbearing potential who are not using adequate contraception
•Patients with cerebrovascular disease (strokes)
•Patients with psychotic disorders or cognitive impairment

发起方

Greater Glasgow Health Board/University of Glasgow