A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.
研究概览
简要总结
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
详细描述
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.
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
- •18 years of age and older
- •Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
- •Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
- •patient must sign ICF
排除标准
- •Women who are pregnant and/or nursing
- •Previous treatment with MNTX
- •Participation in any other studies involving investigational products within 30 days prior to screening
研究组 & 干预措施
Arm 1
干预措施: SC Methylnaltrexone (Drug)
Arm 2
干预措施: SC Placebo (Drug)
结局指标
主要结局
Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.
时间窗: 2 weeks
To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.
次要结局
未报告次要终点