A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
研究概览
简要总结
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must not be pregnant or breastfeeding and agree to use birth control;
- •Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
- •Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
- •Demonstrates English fluency and has access to a touch-tone telephone.
排除标准
- •Recent history of mushy or watery stools;
- •Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
- •Clinically-significant alarm symptoms;
- •Secondary causes of constipation or evacuation disorders;
- •Surgery to the gastrointestinal tract;
- •Usage of prohibited medications.
研究组 & 干预措施
72 ug linaclotide acetate
干预措施: Linaclotide Acetate (Drug)
145 ug linaclotide acetate
干预措施: Linaclotide Acetate (Drug)
290 ug linaclotide acetate
干预措施: Linaclotide Acetate (Drug)
579 ug linaclotide acetate
干预措施: Linaclotide Acetate (Drug)
Matching Placebo
干预措施: Matching placebo (Drug)
结局指标
主要结局
Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
时间窗: Change from Baseline to Week 12
The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.
次要结局
- CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)(Change from Baseline to Week 12)
- Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period(Change from Baseline to Week 12)
- Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period(Change from Baseline to Week 12)
- Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period(Change from Baseline to Week 12)
- Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period(Change from Baseline to Week 12)
- Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period(Change from Baseline to Week 12)