NCT01117051终止3 期
A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride in Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 174
- 主要终点
- Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week
研究概览
简要总结
The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.
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 (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
Resolor
Active Comparator
prucalopride
干预措施: prucalopride (Drug)
结局指标
主要结局
Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week
时间窗: 12 weeks
A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.
次要结局
- Plasma Concentration of Prucalopride at Week 2(Week 2)
- Plasma Concentration of Prucalopride at Week 8(Week 8)
研究者
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