Vibrant Capsule vs. Placebo for Patient Suffering From Constipation

Study Overview
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Brief Summary
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The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week

Detailed Description
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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

Official Title
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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

Conditions
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Constipation Chronic Idiopathic

Intervention / Treatment
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* Device: Vibrant capsule
* Device: Placebo capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active capsule<br>The Vibrant non-biodegradable capsule administrated twice a week | Device: Vibrant capsule<br>* Vibrant capsule - Administered twice a week (Monday and Thursday).<br>|
| Placebo Comparator: Placebo<br>The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week | Device: Placebo capsule<br>* Placebo Capsule administered twice a week (Monday and Thursday)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSBM 1 success rate: Increase of at least one Complete Spontaneous Bowel Movement (CSBM) a week from BL. | 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 | up to 8 weeks of treatment | 
| Increase of at least two Complete Spontaneous Bowel Movement (CSBM) a week from BL | CSBM2 success rate, defined as 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 | up to 8 weeks of treatment | 
| adverse events | Safety endpoints include all adverse events related and unrelated to the study treatment | up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Straining based on the subject's assessment recorded in daily diaries (Scale range from 0- No straining to 10 Unbearable straining) | Change from baseline in average straining based on the subject's account in daily diary reports. The straining level reported by the patient on a scale ranged from 0 - No straining to 10 Unbearable straining. The change from baseline in average straining was modeled with an Analysis of Covariance (ANCOVA) mode. | up to 10 weeks | 
| CSBM1 expanded success rate, | CSBM1 expanded success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment | up to 8 weeks of treatment | 
| CSBM2 expanded success rate | defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment | up to 8 weeks of treatment | 
| Bloating based on the subject's assessment recorded in daily diaries (Scale ranged from 0- No bloating to 10 Unbearable bloating) | Change from baseline in average bloating based on the subject's account in daily diary reports. The bloating level reported by the patient on a scale ranged from 0 - No bloating to 10 Unbearable bloating. The change from baseline in average bloating was modeled with an Analysis of Covariance (ANCOVA) mode. | up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Vibrating capsule, Chronic Idiopathic Constipation