NCT02030756已完成不适用
Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device 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
- 144
- 试验地点
- 18
- 主要终点
- Frequency of bowel movements
研究概览
简要总结
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).
- •Patients with more than 1 bowel movement/2 weeks and < 3 bowel movement/week.
- •Colonoscopy performed in the past 10 years prior to study participation, unless the patients are <50 years old and without alarming signs and symptoms
- •Patient signed ICF
- •For women with childbearing potential, adequate contraception
排除标准
- •History of complicated/obstructive diverticular disease
- •History of intestinal or colonic obstruction.
- •History of significant GI disorder.
- •Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids
- •Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.
- •Presence of pacemaker.
- •History of, or current eating disorders, such as anorexia, 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 GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.
- •History of Zenker's diverticulum, dysphagia or a known esophageal stricture
- •Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
- •Participation in another clinical study in the last 4 months prior to screening.
- •Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.
- •Women who are pregnant or lactating.
研究组 & 干预措施
Vibrating capsule
Active Comparator
patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
干预措施: vibrating capsule (Device)
sham non-vibrating capsule
Sham Comparator
patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
干预措施: sham non-vibrating capsule (Device)
结局指标
主要结局
Frequency of bowel movements
时间窗: 3 months
change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups
次要结局
未报告次要终点
研究者
研究点 (18)
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