A Phase II, Randomized, Placebo-controlled, Double-blind, Multicenter, 12 Week Study to Assess the Efficacy and Safety of Mesalamine Granules 750 mg and 1,500 mg Capsules Administered Once Daily in the Treatment of Irritable Bowel Syndrome With Diarrhea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 148
- 主要终点
- The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
研究概览
简要总结
The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria
- •Meet the following IBS symptom scores in all categories during the diary eligibility period:
- •An average daily score of greater than or equal to 3 for abdominal pain
- •An average daily score of greater than or equal to 3 for bloating
- •An average daily score of 5 or greater for stool consistency using the Bristol Stool Scale
- •Does not have adequate relief of IBS symptoms (weekly reported) over the past 7 days on the first day of screening and on the day of randomization
排除标准
- •Present with hard or lumpy stools (Type 1 or Type 2) on the Bristol Stool form Scale during the diary eligibility period
- •history of inflammatory bowel disease
- •has Type 1 or 2 diabetes
- •pregnant or lactating
- •history of HIV or hepatitis B or C
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Mesalamine Granules 750 mg
干预措施: Mesalamine Granules 750 mg (Drug)
Mesalamine Granules 1500 mg
干预措施: Mesalamine Granules 1500 mg (Drug)
结局指标
主要结局
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
时间窗: 3 months
A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.
次要结局
- Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period(3 months)