Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 213
- 主要终点
- Change From Baseline in Mean Highest-Average-Pain Score at Week 4
研究概览
简要总结
This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Irritable Bowel Syndrome
- •Moderate or severe IBS pain
排除标准
- •Any other uncontrolled disease
- •Pregnant or nursing females
研究组 & 干预措施
AGN 203818 3 mg
Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks
干预措施: AGN 203818 (Drug)
AGN 203818 20 mg
Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
干预措施: AGN 203818 (Drug)
AGN 203818 60 mg
Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
干预措施: AGN 203818 (Drug)
Placebo
Part A: Placebo capsule every 12 hours for 4 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Highest-Average-Pain Score at Week 4
时间窗: Baseline, Week 4
Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).
次要结局
- Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4(Week 4)
- Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4(Week 4)
- Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)(Baseline, Week 4)