A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,722
- 试验地点
- 1
- 主要终点
- 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
研究概览
简要总结
This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand.
The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).
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
- Double (Participant, Investigator)
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 signed an Informed Consent Form(ICF).
- •Patient Must not be pregnant or breastfeeding and agree to use birth control
- •Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
- •Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
- •Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms
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
- •Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
- •Surgery to the gastrointestinal tract
- •Usage of prohibited medications
研究组 & 干预措施
controlled arm
干预措施: Placebo (Drug)
treatment arm
干预措施: Linaclotide (Drug)
结局指标
主要结局
12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
时间窗: Baseline and Weeks 1-12 during the Treatment Period
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
时间窗: Baseline and Weeks 1-12 during the Treatment Period
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
次要结局
- Change From Baseline in 12-week Severity of Straining(Baseline and 12-week Treatment Period)
- Change From Baseline in 12-week Abdominal Pain(Baseline and 12-week Treatment Period)
- Change From Baseline in 12-week Stool Consistency(Baseline and 12-week Treatment Period)
- Change From Baseline in 12-week Abdominal Bloating(Baseline and 12-week Treatment Period)
- Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate(Baseline and 12-week Treatment Period)
- Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate(Baseline and 12-week Treatment Period)
- Change From Baseline in 12-week Abdominal Discomfort(Baseline and 12-week Treatment Period)