NCT01367613已完成3 期
A Three-Month Open-Label Treatment Extension of Protocol MNTX 302
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
- 89
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 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
- •Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX
- •Negative pregnancy test
- •Stable vital signs
排除标准
- •Women who are pregnant and/or nursing
- •Received any investigational product, other than MNTX, in the past 30 days
- •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 (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: 3 months
To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302
次要结局
未报告次要终点
研究者
研究点 (1)
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