A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 711
- 试验地点
- 1
- 主要终点
- Adequate Relief
研究概览
简要总结
The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.
详细描述
We have fulfilled our enrollment requirements for this study.
This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study.
Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).
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
- •fulfilling Rome III criteria for IBS-D
排除标准
- •major cardiovascular disease
- •psychiatric illness except mild or moderate depression
- •pregnancy
- •presence of other GI disease that could explain IBS-like symptoms
- •history of major gastric, hepatic, pancreatic or intestinal surgery or perforation
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
干预措施: Rezular 15mg (Drug)
Rezular 37.5mg
干预措施: Rezular (Drug)
Rezular - 75mg
干预措施: Rezular (Drug)
结局指标
主要结局
Adequate Relief
时间窗: 8 weeks
次要结局
未报告次要终点