NCT01306448已完成不适用
Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vibrant Ltd.
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
详细描述
Healthy volunteers will be followed for safety for 7 days after taking the capsule.
Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 18-60 years
- •Ability of subject to understand character and individual consequences of clinical trial
- •Written informed consent must be available before enrollment in the trial
- •For women with childbearing potential, adequate contraception
排除标准
- •Patient with Diverticulosis
- •Patient must not use protocol-defined prohibited medicine
- •History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
- •Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
- •Presents of pacemakers
- •History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
- •Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia.
- •Actively participating in another clinical trial
研究组 & 干预措施
vibrating capsule
Experimental
干预措施: Vibrant capsule (Device)
结局指标
主要结局
Number of patients with adverse events
时间窗: 7.5 weeks of treatment period
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
次要结局
- Patient assessment of capsule tolerability(7.5 weeks of treatment period)
- Change in spontaneous bowel movement per week compared to baseline(9.5 weeks)
研究者
研究点 (3)
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