NCT00501241终止2 期
A Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
Procter and Gamble4 个研究点 分布在 2 个国家目标入组 214 人开始时间: 2007年7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
- 终止
- 发起方
- 入组人数
- 214
- 试验地点
- 4
- 主要终点
- Total number of spontaneous bowel movements during the first 7 days after randomization
研究概览
简要总结
The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.
详细描述
This study is designed to evaluate the safety and efficacy of ATI 7505 in generally healthy, adult patients who have had symptoms of chronic idiopathic constipation for at least 6 months as defined in the ROME III criteria.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •18 and 75 years of age
- •constipation symptom onset at least 6 months ago & meet ROME III criteria for chronic constipation
- •negative colonoscopy or air contrast barium enema within the past 2 years if ≥50 years of age or within the past 5 years if <50 years of age;
- •are able to refrain from use of medications known to treat constipation or associated symptoms throughout the study
排除标准
- •transabdominal surgery, unstable coronary artery disease, organic gastrointestinal disease, collagen vascular disease, or any alarm symptoms within the 6 months prior to screening;
- •taking prohibited medications (including laxatives, herbal remedies)
- •participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion;
- •QTcB >440 msec, abnormal 12-lead ECG, family history of sudden death at age <40 years or history of long QT syndrome
- •alcohol or drug abuse within the 6 months prior to screening;
- •autonomic dyssynergic defecation
研究组 & 干预措施
1
Placebo Comparator
placebo twice daily
干预措施: ATI-7505 (Drug)
2
Experimental
20 mg ATI-7505, BID for 4 weeks
干预措施: ATI-7505 (Drug)
3
Experimental
40 mg ATI, BID, 4 weeks
干预措施: ATI-7505 (Drug)
4
Experimental
80 mg ATI-4505, BID for 4 weeks
干预措施: ATI-7505 (Drug)
5
Experimental
120 mg ATI-7505, BID for 4 weeks
干预措施: ATI-7505 (Drug)
结局指标
主要结局
Total number of spontaneous bowel movements during the first 7 days after randomization
时间窗: 7 days
次要结局
- Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period(daily and or weekly)
研究者
研究点 (4)
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