NCT00813098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 LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
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
- 155
- 试验地点
- 36
- 主要终点
- Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-70 years old
- •Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria
- •Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods
- •Normal structural evaluation of the colon within 5 years prior to screening
- •Ability to provide written informed consent
排除标准
- •Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study
- •Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility
- •Lactose intolerance
- •Major psychological disorder
- •Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)
研究组 & 干预措施
High dose
Experimental
A high dose of LX1031; daily oral intake for 28 days
干预措施: LX1031 High Dose (Drug)
Low Dose
Experimental
A low dose of LX1031; daily oral intake for 28 days
干预措施: LX1031 Low Dose (Drug)
Placebo
Placebo Comparator
Matching placebo dosing with daily oral intake
干预措施: Placebo (Drug)
结局指标
主要结局
Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
时间窗: Week 4
The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,"In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"
次要结局
- Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate(Baseline to Week 4)
- Change From Baseline at Week 4 in Stool Consistency Scores(Baseline to Week 4)
- Change From Baseline at Week 4 on the Severity of Bloating(Baseline to Week 4)
- Change From Baseline at Week 4 on the Global Improvement Score.(Baseline to Week 4)
- Change From Baseline at Week 4 in Stool Frequency(Baseline to Week 4)
研究者
研究点 (36)
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