A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, 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
- 100
- 试验地点
- 4
- 主要终点
- CSBM 1 Success Rate
研究概览
简要总结
The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
详细描述
The study is a prospective, randomized, multicenter, adaptive design, double blinded clinical study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
Two arms will be assessed (at a ratio of 1:1 of Vibrant Treatment vs. placebo):
- Vibrant Capsule administered twice a week (Monday and Thursday)
- Placebo Capsule administered twice a week (Monday and Thursday) Subjects will come 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.
During the entire study period subjects will be asked to refrain from taking any medications or supplements to relieve their constipation.
Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement
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 is a double-blind study. The subjects and the evaluators will be blinded to the treatment allocated to each subject. Each site will assign an unblinded person that will handle all issues related to capsule administration and accountability. The unblinded person will not be involved in any subject's assessments. Rest of the site staff will remain blind throughout 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 IV criteria
- •Subjects who have not experienced relief of their symptoms from one or more available therapies (for at least one month at recommended dose) or unable to tolerate these therapies
- •Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week (as a result of at least 1 SBM and not more than 3 SBMs during each of the run-in weeks)
- •Subjects above 50 years old or <50 years old and with alarm signs should have colonoscopy performed within 10 years prior to study participation. Colonoscopy results should exclude GI obstruction and/or GI malignancy
- •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)
- •Clinical evidence of current and significant gastroparesis
- •Use of any of the following medications:
- •Medications that may affect intestinal motility (including but not limited to prokinetics, anti-Parkinsonian medications, opiates, opioids, Verapamil, Nifedipine, iron, magnesium supplements, Tricyclic antidepressants (TCAs), Heparin, Warfarin and Baclofen.
- •With the exception of antidepressants (other than TCAs), 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, gastric electrical stimulator or any electrical implanted device.
- •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 capsule's transit
- •History of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis 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 interventional 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, beeswax, Calcium Carbonate, Gelatin, Glycerin or Titanium dioxide
- •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
CSBM 1 Success Rate
时间窗: up to 8 weeks of treatment
CSBM1 Success Rate: defined as the number of Participants 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. 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.
CSBM2 Success Rate
时间窗: up to 8 weeks of treatment
CSBM2 Success Rate: defined as the number of Participants 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. 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
- CSBM1 Expanded Success Rate,(up to 8 weeks of treatment)
- CSBM2 Expanded Success Rate(up to 8 weeks of treatment)
- Change From Baseline in Stool Consistency(up to 10 weeks)
- Straining Based on the Subject's Assessment Recorded in Daily Diaries(up to 10 weeks)