NCT03097861已完成3 期
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, 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
- 入组人数
- 552
- 试验地点
- 3
- 主要终点
- Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
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
- Quadruple (Participant, Care Provider, 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
- •Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.
- •Is male or female, 18 or older years of age
- •Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure
排除标准
- •Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
- •Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting
研究组 & 干预措施
Lubiprostone Capsule
Active Comparator
Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.
干预措施: Lubiprostone (Drug)
Lubiprostone Sprinkle
Experimental
Lubiprostone 24 mcg sprinkle BID for 7 days.
干预措施: Lubiprostone (Drug)
Placebo
Placebo Comparator
Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
时间窗: during the 1-week treatment period
Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.
次要结局
- Mean SBM Straining Score Within 1 Week(during the 1-week treatment period)
- Mean SBM Consistency Score Within 1 Week(during the 1-week treatment period)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From first dose of study medication to follow-up (up to 15 days))
研究者
研究点 (3)
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