A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vibrant Ltd.
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- CSBM1- an Increase of at Least One 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 pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Three arms that assessed:
- Vibrant Capsule with vibrating mode 1 administered 5 times per week
- Vibrant Capsule with vibrating mode 2 administered 5 times per week
- Sham Capsule administered 5 times per week
详细描述
Subjects will be followed continuously for at least a 2 weeks run-in period and then be randomized to either Vibrant or Sham capsules for a treatment period of 8 weeks. The first 2 weeks of treatment will be considered as a subjects' training period.
Data reporting will be done on an electronic Case Report Form and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period.
After the run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit.
Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period.
Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.
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 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 per week and ≥1 Spontaneous Bowel Movements 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
- •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
- •History of gastroparesis
- •Use of any of the following medications:
- •Medications that may affect intestinal motility, prokinetics, 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
研究组 & 干预措施
Active Comparator-Vibrating Mode 1
Patients will receive vibrating capsule Vibrating Mode 1 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
干预措施: Vibrating Capsule (Device)
Active Comparator-Vibrating Mode 2
Patients will receive vibrating capsule Vibrating Mode 2 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions
干预措施: Vibrating Capsule (Device)
Sham Comparator
Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week). The Sham capsule is visually similar to the active capsules (Active Mode 1 and Active Mode 2, which differ in their vibration sessions) but without the active components.
干预措施: Sham capsule (Device)
结局指标
主要结局
CSBM1- 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 base line of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
CSBM2- an Increase of at Least Two Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
时间窗: 6-8 weeks
CSBM2 success rate, defined as an increase from the base line of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.
次要结局
- SBM 1- Success Rate, Defined as as an Increase From the Base Line of at Least One Weekly Spontaneous Bowel Movement (SBM) During at Least 6 of the 8 Weeks of Treatment.(6-8 weeks)