NCT01367600已完成3 期
A Three-Month Open-Label Treatment Extension of Protocol MNTX 301
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
- 27
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment
- •Negative pregnancy test
排除标准
- •Women who are pregnant and/or nursing
- •Any concurrent experimental drug therapy
- •Evidence of fecal impaction
- •Clinically significant active diverticular disease
研究组 & 干预措施
Arm 1
Experimental
干预措施: SC Methylnaltrexone (MNTX) (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: 3 months
To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.
次要结局
- Change from baseline in pain scores(3 months)
- Number of patients with opioid withdrawal symptoms(3 months)
研究者
研究点 (1)
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