A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 633
- 试验地点
- 4
- 主要终点
- Complete Spontaneous Bowel Movement (CSBM) Overall Responder
研究概览
简要总结
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder
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
- •Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
- •Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
- •Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
- •Patient demonstrates continued chronic constipation through Pretreatment Period
- •Patient is compliant with IVRS
排除标准
- •Patient has history of loose or watery stools
- •Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
- •Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
- •Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
研究组 & 干预措施
2
Linaclotide 145 micrograms
干预措施: Linaclotide 145 micrograms (Drug)
1
Linaclotide 290 micrograms
干预措施: Linaclotide 290 micrograms (Drug)
3
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
时间窗: Change from Baseline to Week 12
A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
次要结局
- 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate(Change from Baseline to Week 12)
- 12-Week Spontaneous Bowel Movement (SBM) Frequency Rate(Change from Baseline to Week 12)
- 12-Week Stool Consistency(Change from Baseline to Week 12)
- 12-Week Severity of Straining(Change from Baseline to Week 12)
- 12-Week Abdominal Discomfort(Change from Baseline to Week 12)
- 12-Week Bloating(Change from Baseline to Week 12)
- 12-Week Constipation Severity(Change from Baseline to Week 12)