NCT00454688已完成2 期
A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome
Tioga Pharmaceuticals106 个研究点 分布在 1 个国家目标入组 596 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 596
- 试验地点
- 106
- 主要终点
- Relief of IBS Pain - total months
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.
详细描述
A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-79
- •Must sign an ICF
- •Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
- •Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
- •Must demonstrate a willingness to comply with daily telephone diary entry
排除标准
- •Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
- •Pregnant or breastfeeding females
- •Refusal to discontinue prohibited concomitant medications
- •Use of an investigational drug or participation in an investigational study within 30 days of screening
- •Inability or unwillingness to use the touch-tone telephone data entry system
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Asimadoline 0.15 mg
Experimental
干预措施: Asimadoline (Drug)
Asimadoline 0.5 mg
Experimental
干预措施: Asimadoline (Drug)
Asimadoline 1.0 mg
Experimental
干预措施: Asimadoline (Drug)
结局指标
主要结局
Relief of IBS Pain - total months
时间窗: 12 weeks
The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.
次要结局
- Relief of IBS Pain - percent of patients(12 weeks)
- Relief of IBS Symptoms(12 weeks)
- Lower GI function - change from baseline(12 weeks)
- Abdominal Pain Score - change from baseline(12 weeks)
- Abdominal Discomfort Score - change from baseline(12 weeks)
研究者
研究点 (106)
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