A Phase 4, Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Abdominal Girth at Week 4
研究概览
简要总结
The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.
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 meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal bloating and abdominal girth
排除标准
- •Patient has history of loose or watery stools
- •Patient has both clinically significant findings and unexplained clinically significant alarm symptoms
- •Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
- •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
290 μg linaclotide
Linaclotide Oral, once daily
干预措施: Linaclotide (Drug)
Matching Placebo
Matching Placebo Oral, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Abdominal Girth at Week 4
时间窗: Baseline, Week 4
Mean change in abdominal girth (physical measure of bloating/distension) as measured by area under the curve (AUC), determined by 24-hour abdominal inductance plesthymography (AIP; with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient's number of hours of measurement included in the AUC. (Therefore, the time element was removed from the standardized AUC, and the unit of measure for this outcome is centimeters \[cm\]).
次要结局
- Change From Baseline in Abdominal Girth at Week 2(Baseline, Week 2)
- Percent Change From Baseline in Maximal Abdominal Girth at Week 4(Baseline, Week 4)
- Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 4(Baseline, Week 4)
- Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1(Baseline, Week 1)
- Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2(Baseline, Week 2)
- Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3(Baseline, Week 3)
- Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 4(Baseline, Week 4)
- Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 2(Baseline, Week 2)
- Change From Baseline in Bristol Stool Form Scale (BSFS) Over Time(Baseline, Week 1, Week 2, Week 3, Week 4)