NCT01367548已完成2 期
A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Time to tolerance of liquids
研究概览
简要总结
A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.
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
- Double
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
- •Males and females, 18 yrs or older
- •Patients who have undergone a segmental colectomy
- •Must be receiving opioids via IV.
排除标准
- •Patients who received any experimental drug in the last 30 days
- •Patients receiving spinal medication for post-operative pain relief
- •Patients who have undergone operations for complications related to inflammatory bowel disease
- •Patients with recent history of abdominal radiation therapy.
研究组 & 干预措施
Arm 1
Experimental
干预措施: IV Methylnaltrexone (MNTX) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to tolerance of liquids
时间窗: 7 days
To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
次要结局
- Time to first micturition post foley catheter removal(7 days)
- Time to hospital discharge(7 days)
- Time to first bowel movement(7 days)
- Time to tolerance of solid foods(7 days)
研究者
研究点 (1)
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