Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).
研究概览
简要总结
Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?
详细描述
This is a randomized double-blind placebo-controlled pilot study that will use validated bowel questionnaires to evaluate the effects of ranolazine administered orally twice daily in patients with diarrhea predominant IBS (IBS-D). The study will consist of a 2 week run in period, followed by 4 weeks of treatment period with oral ranolazine 1000 mg twice daily. Primary endpoint of the study will be the average Bowel Symptom Scale (BSS) scores for diarrhea and adequate relief of IBS pain and discomfort are secondary end points.
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, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ranolazine
tablet, 1000 mg twice daily for four weeks
干预措施: Ranolazine (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).
时间窗: baseline to 4 weeks
BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.
次要结局
- Mean Abdominal Pain(baseline to 4 weeks)
研究者
Yuri A. Saito Loftus
Associate Professor of Medicine
Mayo Clinic