NCT00605644已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain
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
- 128
- 主要终点
- Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).
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, Investigator, Outcomes Assessor)
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
- •Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
- •Taking oral, transdermal, intravenous, or subcutaneous opioids.
- •Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.
排除标准
- •History of chronic constipation before the initiation of opioid therapy.
- •Other GI disorders known to affect bowel transit.
- •Women who are pregnant, breast feeding, or plan to become pregnant.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
150 mg
Experimental
MOA-728
干预措施: MOA-728 (Drug)
300 mg
Experimental
MOA-728
干预措施: MOA-728 (Drug)
450 mg
Experimental
MOA-728
干预措施: MOA-728 (Drug)
600 mg
Experimental
MOA-728
干预措施: MOA-728 (Drug)
结局指标
主要结局
Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment
时间窗: 3 hours
次要结局
未报告次要终点
研究者
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