NCT00401362已完成3 期
A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Efficacy of SC MNTX compared with placebo in inducing laxation
研究概览
简要总结
To test the effectiveness of MNTX in advanced illness subjects.
详细描述
To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Advanced medical illness with a life expectancy of 1 to 6 months
- •No clinically significant laxation within 48 hours prior to the first dose of study drug
- •On stable opioid and laxative regimen for a least 3 days prior to treatment
- •Age greater than 18years
- •Females of child-bearing age must have a negative pregnancy test.
排除标准
- •Females who are pregnant or nursing.
- •Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
- •Any disease process suggestive of gastrointestinal obstruction
- •Fecal ostomy.
研究组 & 干预措施
Arm 1
Experimental
干预措施: SC Methylnaltrexone (Drug)
Arm 3
Placebo Comparator
干预措施: SC Placebo (Drug)
Arm 2
Experimental
干预措施: SC Methylnaltrexone (Drug)
结局指标
主要结局
Efficacy of SC MNTX compared with placebo in inducing laxation
时间窗: 29 days
The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.
次要结局
未报告次要终点
研究者
研究点 (1)
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