NCT01494233已完成2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
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
- 373
- 试验地点
- 1
- 主要终点
- Change from baseline in stool consistency
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis
- •Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)
- •Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale
- •Ability to provide written, informed consent
排除标准
- •Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.
- •Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
- •Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
- •Any abnormalities or conditions deemed by the investigator as clinically significant
研究组 & 干预措施
Low dose
Experimental
500 mg LX1033 two times daily
干预措施: 250 mg LX1033 tablets (Drug)
Mid dose
Experimental
500 mg LX1033 three times daily
干预措施: 250 mg LX1033 tablets (Drug)
High dose
Experimental
1000 mg LX1033 two times daily
干预措施: 250 mg LX1033 tablets (Drug)
Placebo
Placebo Comparator
Matching placebo dosing
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Change from baseline in stool consistency
时间窗: 4 weeks
次要结局
- Change from baseline in worst abdominal pain in past 24 hours(4 weeks)
- Change from baseline in plasma 5-HIAA levels(4 weeks)
研究者
研究点 (1)
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