NCT01714843已完成2 期
Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 559
- 主要终点
- Global assessment of relief of IBS symptoms Responder
研究概览
简要总结
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
详细描述
This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month during the 3 months before screening examination associated with at least 2 out of the following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a change in frequency of stool; and (3) Onset associated with a change in form (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before the screening examination period.
- •Patients with ≥25% of stools hard or lumpy (with each bowel movement occurring without antidiarrheal, laxative, suppository or enema) and <25% of them loose (mushy) or watery during the 3 months before the screening examination.
- •Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of IBS symptom and had no organic changes.
排除标准
- •Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
- •Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function
- •Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort
- •Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the "Severity Criteria for Drug Adverse Reaction" and judged to be clinically significant
研究组 & 干预措施
ASP0456 lowest dose group
Experimental
oral
干预措施: linaclotide (Drug)
ASP0456 low dose group
Experimental
oral
干预措施: linaclotide (Drug)
ASP0456 middle dose group
Experimental
oral
干预措施: linaclotide (Drug)
ASP0456 high dose group
Experimental
oral
干预措施: linaclotide (Drug)
placebo group
Placebo Comparator
oral
干预措施: placebo (Drug)
结局指标
主要结局
Global assessment of relief of IBS symptoms Responder
时间窗: Weekly for 12 weeks
次要结局
- Abnormal bowel habits improvement Responder(Weekly for 12 weeks)
- Abdominal pain/discomfort relief Responder(Weekly for 12 weeks)
- Changes in weekly average of SBM frequency(Weekly for 12 weeks)
- Changes in weekly average of CSBM frequency(Weekly for 12 weeks)
- SBM (Spontaneous Bowel Movement) Responder(Weekly for 12 weeks)
- CSBM (Complete SBM) Responder(Weekly for 12 weeks)
- Changes in weekly average of stool form scores(Weekly for 12 weeks)
- Changes in weekly average of abdominal pain/discomfort severity(Weekly for 12 weeks)
- Changes in weekly average of straining severity(Weekly for 12 weeks)
- Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)(Weekly for 12 weeks)
- Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs(for 12 weeks)
研究者
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