A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 1
- 主要终点
- Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (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
- •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 diagnosis of IBS-C
- •Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain
- •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
Placebo
干预措施: Linaclotide or Matching Placebo (Drug)
290 μg Linaclotide
干预措施: Linaclotide or Matching Placebo (Drug)
结局指标
主要结局
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
时间窗: Change from Baseline to Week 12
A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.
Abdominal Pain Responder, 9 Out of 12 Weeks
时间窗: Change from Baseline to Week 12
A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
时间窗: Change from Baseline to Week 12
A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. 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.
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks
时间窗: Change from Baseline to Week 12
A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.
次要结局
- Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment(Change from Baseline to Week 12)
- Abdominal Pain Responder for 6 Out of 12 Weeks(Change from Baseline to Week 12)
- 12-Week Percent of Abdominal Pain-free Days(Change from Baseline to Week 12)
- 12-Week Spontaneous Bowl Movement (SBM) Frequency(Change from Baseline to Week 12)
- 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency(Change from Baseline to Week 12)
- 12-Week Change in Severity of Straining(Change from Baseline to Week 12)
- 12-Week Change in Abdominal Pain Score(Change from Baseline to Week 12)
- 12-Week Change in Stool Consistency(Change from Baseline to Week 12)
- 12-Week Change in Abdominal Discomfort(Change from Baseline to Week 12)
- 12-Week Change in Bloating(Change from Baseline to Week 12)