Pharmacological treatment of insomnia in palliative care A randomized, double-blind, placebo controlled, parallel-group, multicenter trial investigating the short time effectiveness of zopiclone on self-reported sleep quality in patients with advanced cancer who use opioids and who report insomnia - Sleep RCT

St. Olavs Hospital, trondheim University Hospital0 个研究点目标入组 100 人开始时间: 2016年2月3日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•Histologically verified malignant disease
•Presence of metastatic / disseminated disease
•Presence of insomnia syndrome
•Must be at least 18 years of age
•Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment dose corresponding to step III at the WHO pain ladder with a stable dose for at least 2 days
•Able to comply with all study procedures
•Signed 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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•On-going treatment or previous treatment (within 4 weeks) for more than consecutive 3 days with medications given for insomnia.
•Adverse reactions to zopiclone
•History of substance abuse
•Concomitant use of rifampicin and erythromycin
•Any other contraindication for zopiclone
•Unfit for participation for any reason as judged by the investigator
•Severe cognitive impairment as assessed by the investigator
•Pregnancy or lactation
•Scheduled surgery within the next week
•In the need of change in opioid dose at baseline (study visit 1)
•Scheduled intravenous administration of chemotherapy during the study period (from baseline to day 8) or intravenous administration of chemotherapy during the last week
•Change in corticosteroid dose last week before baseline or planned dose change within 7 days from baseline

发起方

St. Olavs Hospital, trondheim University Hospital