Sublingual methadone for the management of cancer-related breakthrough pain in outpatients: a phase II multicentre, open label, feasibility study

Alberta Cancer Board (Canada)0 个研究点目标入组 42 人开始时间: 2006年7月6日最近更新: 2019年2月11日

适应症

试验速览

暂无简介。

•Patients aged 18 years and older are eligible if they have:
•1. Pain due to cancer or its treatment
•2. Controlled baseline pain
•3. Episodes of breakthrough pain every day that are 4/10 in severity or greater, last ten minutes or longer, and are responsive to short acting oral opioids such as morphine or hydromorphone
•4. Able to hold a volume of 1.0 cc of water under the tongue for a five minute period
•5. Able to provide written, informed consent
•6. Able to fill out the study forms

•1. Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses of opioid
•2. Prior sensitivity to methadone
•3. Currently taking methadone
•4. Breakthrough pain that in the opinion of the investigator is likely to change within the next seven days as a result of any of the following:
•4.1. Recent or imminent radiation therapy to the main site of pain
•4.2. New use of chemotherapy
•4.3. Use of an injectable bisphosphonate likely to alter the pain
•4.4. New use of corticosteroids within the past week with a corresponding change in pain
•4.5. Other interventions judged likely to alter the pain
•5. Are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

发起方

Alberta Cancer Board (Canada)