NCT01993875已完成3 期
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 164
- 主要终点
- Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
研究概览
简要总结
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
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
- •Medically-confirmed diagnosis of chronic idiopathic constipation
- •Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
- •Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors
排除标准
- •Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
- •Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
研究组 & 干预措施
Lubiprostone
Experimental
干预措施: Lubiprostone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
时间窗: within 1 week
SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
次要结局
- Overall Stool Consistency at Week 1(at Week 1)
- Mean Change From Baseline in Stool Consistency at Week 1(Baseline and Week 1)
- Mean Change From Baseline in Straining at Week 1(Week 1)
- Overall Straining at Week 1(Week 1)
- Consistency of SBMs at Week 1(at Week 1)
研究者
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