Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting
研究概览
简要总结
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain due to cancer or its treatment; controlled baseline pain;
- •episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
- •ast 10 minutes or longer, and
- •are responsive to short acting oral opioids such as morphine or hydromorphone;
- •are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
- •are able to fill out the study forms
排除标准
- •Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
- •prior sensitivity to methadone;
- •currently are being administered methadone;
- •have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
- •new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
- •are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely
研究组 & 干预措施
Pharmacokinetic
One episode of breakthrough pain was to be evaluated per patient. Clinical status and bloodwork was evaluated prior to entering into this phase of the trial, and patients were eligible if bloodwork demonstrated a HgB of >90 g/L with no concurrent bleeding. A peripheral intravenous catheter was inserted and saline locked. When breakthrough pain was experienced, methadone was administered, and the patient completed a pain intensity numeric rating scale at time 0 and every 10 minutes for one hour. A 10 cc specimen of blood was collected prior to administration of methadone, and again every 10 minutes for one hour. Blood was collected without anticoagulant, allowed to clot, separated by centrifugation, and serum samples flash frozen. Serum methadone levels were quantified by LC/MS/MS with comparison to isotopically labeled internal standards
干预措施: Sublingual Methadone (Drug)
结局指标
主要结局
to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting
时间窗: 12 months
次要结局
- to demonstrate proof of concept(Baseline to 5 years)
- to develop a model of PK/PD study of breakthrough pain(Baseline to 5 years)
- to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)(Baseline to 5 years)