Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)

Study Overview
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Brief Summary
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The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.

Detailed Description
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Visit 1 -Screening: Subjects will be screened to the study at the screening visit, PAC-QOL questionnaire will be completed and subject will have a run-in time for a period of 2-3 weeks, assuring 14 consecutive days of eDiary with an average of < 3 SBM per week. Visit 2 - Baseline: After the run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be randomized to either Vibrant or Vibrant placebo for a treatment period of 8 weeks. Subjects, in both arms, will have their first administration of Vibrant capsule / Vibrant placebo on site at the day of baseline visit and will be instructed on their treatment administration at home and will be requested to ingest the capsules at a specific time of the day. At baseline, subjects will also be trained on how to use the base unit at home. Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study (including the run-in period). The eDiary will include questions on: Daily BM, SBM, CSBM Change of their diet, if applicable (NOTE: the protocol will not ask/require the subjects to change anything in his/her diet) Change in sympotms as: brisol stool consistancy, straining, bloating, and the other questions in the eDiary Medication AE (including diarhrea) The first 2 weeks of treatment will be considered as a subjects' training period. Visit 3 -after 4 weeks of treatment - an on site visit will take place to evaluate subject's safety and treatment efficacy and additional capsule dispencing. Visit 4 Final visit -after another 4 weeks of treatment - an on site visit will take place to evaluate subject's safety and treatment efficacy and collect the base unites and remaning capsules. PAC-QOL, Ease of use and TSQM questionnaires will be completed. During the entire study period, data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period. Subjects will receive phone calls at least once a week and subject compliance will be monitored throughout the 8 weeks of the study. Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement. Data about time of activation of the capsules will be automatically registered and transmitted by the base unit for Vibrant capsules

Official Title
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A Prospective, Multicenter, Randomized, Single Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)

Conditions
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Chronic Idiopathic Constipation

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


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 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 <3 Spontaneous Bowel Movements (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 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) 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 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Activr capsule | Device: Vibrant capsule<br>* The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility<br>* Other names: medical device;|
| Placebo Comparator: Placebo<br>Placebo capsule | Drug: Placebo<br>* A biodegradable capsule, which visually similar to the Vibrant active capsule<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSBM success rate: An increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) | The primary efficacy endpoint is CSBM 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 | change from baseline to 8 weeks | 
| all adverse events related and unrelated to the study treatment | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBM success rate | an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 weeks of treatment | change from baseline to 8 weeks | 
| average stool consistency | the stool consistency is evaluated using the Bristol scale | change from baseline to 8 weeks | 
| average straining | A sacle of 0-10 | change from baseline to 8 weeks | 
| PAC-QoL | patient's questionnaire to evaluate quality of life | change from baseline to 8 weeks |