A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vibrant Ltd.
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
研究概览
简要总结
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Two arms will be assessed:
- Vibrant Capsule administered 5 times per week
- Sham Capsule administered 5 times per week
详细描述
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Two arms will be assessed:
- Vibrant Capsule administered 5 times per week
- Sham Capsule administered 5 times per week
Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks.
Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 22 years and older
- •Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies
- •Subjects with an average of <3 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week
- •Normal colonoscopy performed within 10 years prior to study participation, unless the subjects are <50 years old and without alarm signs and/or symptoms
- •Subject signed the Informed Consent Form (ICF)
- •Female subjects must have a negative pregnancy test
排除标准
- •History of complicated/obstructive diverticular disease
- •History of intestinal or colonic obstruction, or suspected intestinal obstruction.
- •History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
- •History of gastroparesis
- •Use of any of the following medications:
- •Medications that may affect intestinal motility, prokinetics, anti-depressants, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
- •With the exception of antidepressants, thyroid or hormonal replacement therapy, when the subject has been on a stable dose for at least 3 months prior to enrollment.
- •Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.
- •Presence of cardiac pacemaker or gastric electrical stimulator.
- •History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
- •Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
- •History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia
- •Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
- •Subjects with pelvic floor dysfunction/defecatory disorder
- •Participation in another clinical study within one month prior to screening.
- •Women who are pregnant or lactating
结局指标
主要结局
CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
时间窗: 8 Weeks
CSBM2 success rate, defined as an increase from the run-in period of at least 2 weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
时间窗: 8 weeks
CSBM1 success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
次要结局
未报告次要终点