A Prospective, Randomized, Multi-center, Double-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vibrant Ltd.
- 入组人数
- 349
- 试验地点
- 16
- 主要终点
- CSBM1 & CSBM2 Success Rate
研究概览
简要总结
The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
详细描述
Subjects came for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks
Three arms were assessed:
- Vibrant Capsule mode A administered 5 times per week
- Vibrant Capsule mode B administered 5 times per week
- Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time.
Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm.
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
- Double (Participant, Investigator)
盲法说明
This was a double blind, placebo controlled study and both the participant and the investigator were masked. The study investigators, sponsors and participants were all blinded throughout the study. A research pharmacist/investigator who was not involved with evaluating patients or conducting the study, provided training to the participants and dispensed the correct study arm allocation. This individual had no other role in the study.
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 (osmotic and stimulant laxatives used for at least one month at recommended dose)
- •Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week
- •Normal colonoscopy performed within 5 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 blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record [i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)]; in these circumstances, a pregnancy test will not be necessary
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-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): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
- •Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history
- •Participation in another clinical study within one month prior to screening.
- •Women who are pregnant or lactating
- •Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules
- •Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage
- •Subject participated in a previous Vibrant study
- •Subjects planning to undergo MRI during the study
- •Any known allergy to soybean or beeswax or Calcium Carbonate
- •Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
结局指标
主要结局
CSBM1 & CSBM2 Success Rate
时间窗: 8 weeks of treatment
CSBM1Success Rate: defined as the number of subjects with 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. CSBM2 success rate: defined as the number of subject with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment. The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis (Vibrant Capsule Mode A), than in the placebo arm NOTE: * A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. * A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.
次要结局
- Change From Baseline in Average Bloating(8 weeks of treatment)
- Change From Baseline in Average Straining(8 weeks of treatment)
- Change From Baseline in Average Stool Consistency(8 weeks of treatment)